Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-04 @ 10:50 PM
Study NCT ID:
NCT01819233
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2013-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D018275', 'term': 'Carcinoma, Lobular'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicole.simone@jefferson.edu', 'phone': '215-955-6702', 'title': 'Dr. Nicole Simone', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline through 5 weeks after completion of study diet.', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 14, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 38, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 38, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Are Adherent to the Diet Restriction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'comment': 'one sided lower confidence limit as one-sided alpha used.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '74.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 12', 'description': 'Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Fat Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-1.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique', 'unitOfMeasure': 'percentage of change in body fat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'patients who did not complete all assessments were not included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time', 'unitOfMeasure': 'percentage of change in BMI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who did not complete all timepoint measurements were not included.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'only participants who completed all timepoints were included'}, {'type': 'SECONDARY', 'title': 'Patterns of Change Over Time in Serum Markers', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'patients who did not complete all questionnaire timepoints were not included in the analysis'}, {'type': 'SECONDARY', 'title': 'Local Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distant Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Sincere efforts were made to gather and report the data, however, no data is available for this endpoint.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient data was collected to conduct survival analysis as there were participants who were lost to follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Dietary Intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.\n\nBehavioral dietary intervention: Receive caloric restricted dietary intervention\n\nTherapeutic conventional surgery: Undergo definitive lumpectomy\n\nRadiation therapy: Undergo radiation therapy\n\nCounseling intervention: Receive dietary counseling\n\nQuality-of-life assessment: Ancillary studies'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-04', 'size': 5432039, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-22T07:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2013-03-22', 'resultsFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-04', 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Are Adherent to the Diet Restriction', 'timeFrame': 'Up to week 12', 'description': 'Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Fat Measurement', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time'}, {'measure': 'Change in Heart Rate Over Time', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression.'}, {'measure': 'Patterns of Change Over Time in Serum Markers', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression.'}, {'measure': 'Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'timeFrame': 'Baseline to 4 weeks after completion of study', 'description': 'Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)'}, {'measure': 'Local Recurrence', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.'}, {'measure': 'Distant Metastases', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 4 weeks after completion of study', 'description': 'Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ductal Breast Carcinoma in Situ', 'Invasive Ductal Breast Carcinoma', 'Invasive Lobular Breast Carcinoma', 'Lobular Breast Carcinoma in Situ', 'Recurrent Breast Cancer', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20097433', 'type': 'BACKGROUND', 'citation': 'Longo VD, Fontana L. Calorie restriction and cancer prevention: metabolic and molecular mechanisms. Trends Pharmacol Sci. 2010 Feb;31(2):89-98. doi: 10.1016/j.tips.2009.11.004. Epub 2010 Jan 25.'}, {'pmid': '12525670', 'type': 'BACKGROUND', 'citation': 'Hursting SD, Lavigne JA, Berrigan D, Perkins SN, Barrett JC. Calorie restriction, aging, and cancer prevention: mechanisms of action and applicability to humans. Annu Rev Med. 2003;54:131-52. doi: 10.1146/annurev.med.54.101601.152156. Epub 2001 Dec 3.'}, {'pmid': '19867833', 'type': 'BACKGROUND', 'citation': 'Rous P. THE INFLUENCE OF DIET ON TRANSPLANTED AND SPONTANEOUS MOUSE TUMORS. J Exp Med. 1914 Nov 1;20(5):433-51. doi: 10.1084/jem.20.5.433.'}, {'type': 'BACKGROUND', 'citation': 'Tannenbaum A. Effects of Varying Caloric Intake Upon Tumor Incidence and Tumor Growth. Annals of the New York Academy of Sciences. 15 Dec 2006 2006;49(1).'}, {'pmid': '12016155', 'type': 'BACKGROUND', 'citation': 'Berrigan D, Perkins SN, Haines DC, Hursting SD. Adult-onset calorie restriction and fasting delay spontaneous tumorigenesis in p53-deficient mice. Carcinogenesis. 2002 May;23(5):817-22. doi: 10.1093/carcin/23.5.817.'}, {'pmid': '10469616', 'type': 'BACKGROUND', 'citation': 'Zhu Z, Jiang W, Thompson HJ. Effect of energy restriction on tissue size regulation during chemically induced mammary carcinogenesis. Carcinogenesis. 1999 Sep;20(9):1721-6. doi: 10.1093/carcin/20.9.1721.'}, {'pmid': '2337899', 'type': 'BACKGROUND', 'citation': 'Lok E, Scott FW, Mongeau R, Nera EA, Malcolm S, Clayson DB. Calorie restriction and cellular proliferation in various tissues of the female Swiss Webster mouse. Cancer Lett. 1990 May 15;51(1):67-73. doi: 10.1016/0304-3835(90)90232-m.'}, {'pmid': '7937932', 'type': 'BACKGROUND', 'citation': 'Grasl-Kraupp B, Bursch W, Ruttkay-Nedecky B, Wagner A, Lauer B, Schulte-Hermann R. Food restriction eliminates preneoplastic cells through apoptosis and antagonizes carcinogenesis in rat liver. 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Epub 2012 Sep 11.'}, {'type': 'BACKGROUND', 'citation': 'National Institutes of Health. http://www.clincaltrials.gov.'}, {'pmid': '22735163', 'type': 'BACKGROUND', 'citation': 'Arguin H, Dionne IJ, Senechal M, Bouchard DR, Carpentier AC, Ardilouze JL, Tremblay A, Leblanc C, Brochu M. Short- and long-term effects of continuous versus intermittent restrictive diet approaches on body composition and the metabolic profile in overweight and obese postmenopausal women: a pilot study. Menopause. 2012 Aug;19(8):870-6. doi: 10.1097/gme.0b013e318250a287.'}], 'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}, {'url': 'http://www.JeffersonHospital.org', 'label': 'Thomas Jefferson University Hospitals'}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\n1. Investigate the feasibility of a clinical trial administering ionizing radiation with concurrent caloric restriction (CR) for the treatment of breast cancer.\n\n SECONDARY OBJECTIVE:\n2. Investigate measurable changes of patient characteristics and tissue and serum from CR conditions to determine a metric for evaluating this treatment in future studies.\n\nOUTLINE:\n\nBeginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy once daily (QD) 5 days a week for 6 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer\n2. Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes\n3. The patient must be female\n4. Age \\>= 18\n5. If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision\n6. Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:\n\n 1. History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry\n 2. Ipsilateral mammogram within 6 months prior to study entry\n7. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry\n8. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy\n9. Patient must capable of and provide study specific informed consent prior to study entry\n10. Body mass index (BMI) \\>= 21\n11. Weight \\>= 100 lbs\n12. No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix\n13. Patient must not have any of the following severe, active co-morbidity, defined as follows:\n\n 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\n 2. Transmural myocardial infarction within the last 6 months\n 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration\n 5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol\n 6. Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism\n14. Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash\n15. No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields\n16. Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator\n\n 1. Inflammatory bowel disease\n 2. Celiac disease\n 3. Chronic pancreatitis\n 4. Chronic diarrhea or vomiting\n 5. Active eating disorder\n17. Creatinine \\< 1.7\n18. Not currently taking steroids\n19. No currently active pituitary secreting tumors up to physician discretion\n20. No history of or current active drug/alcohol dependence\n21. No patients being decisionally impaired\n\nExclusion Criteria:\n\n1. Patient is not a candidate for breast conservation\n2. Patient is male\n3. Age \\< 18 years\n4. Patient requires regional lymph node irradiation therapy\n5. Patient has evidence of distant metastases\n6. Karnofsky performance status less than 80% within 60 days prior to study\n7. Ipsilateral mammogram done greater than 6 months prior to study\n8. Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)\n9. Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines\n10. BMI \\< 21\n11. Weight \\< 100 lbs\n12. Weight loss \\>= 10% in the last 3 months (mos)\n13. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration\n14. Two or more breast cancers not resectable through a single lumpectomy incision\n15. Non-epithelial breast malignancies such as sarcoma or lymphoma\n16. Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields\n17. Severe, active co-morbidity, defined as follows:\n\n 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\n 2. Transmural myocardial infarction within the last 6 months\n 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration\n 5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol\n 6. Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism\n18. Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash\n19. Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator\n\n 1. Inflammatory bowel disease\n 2. Celiac disease\n 3. Chronic pancreatitis\n 4. Chronic diarrhea or vomiting\n 5. Active eating disorder\n20. Creatinine \\>= 1.7\n21. Current use of steroids\n22. Pituitary secreting tumors up to physician discretion\n23. Active drug/alcohol dependence or abuse history\n24. Decisionally impaired patients'}, 'identificationModule': {'nctId': 'NCT01819233', 'acronym': 'CAREFOR', 'briefTitle': 'Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients', 'orgStudyIdInfo': {'id': '12G.616'}, 'secondaryIdInfos': [{'id': '2012-94', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': 'JT 3024', 'type': 'OTHER', 'domain': 'JeffTrial Number'}, {'id': 'P30CA056036', 'link': 'https://reporter.nih.gov/quickSearch/P30CA056036', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral dietary intervention', 'description': 'Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', 'interventionNames': ['Behavioral: Behavioral dietary intervention', 'Procedure: Therapeutic conventional surgery', 'Radiation: Radiation therapy', 'Other: Counseling intervention', 'Procedure: Quality-of-life assessment']}], 'interventions': [{'name': 'Behavioral dietary intervention', 'type': 'BEHAVIORAL', 'description': 'Receive caloric restricted dietary intervention', 'armGroupLabels': ['Behavioral dietary intervention']}, {'name': 'Therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo definitive lumpectomy', 'armGroupLabels': ['Behavioral dietary intervention']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'otherNames': ['Irradiation', 'Radiotherapy', 'Radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Behavioral dietary intervention']}, {'name': 'Counseling intervention', 'type': 'OTHER', 'otherNames': ['Counseling and communications studies'], 'description': 'Receive dietary counseling', 'armGroupLabels': ['Behavioral dietary intervention']}, {'name': 'Quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['Quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Behavioral dietary intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nicole Simone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}