Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-29 @ 3:45 AM
Study NCT ID:
NCT04553666
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Frailty for Older Cancer Survivors Using Supplements
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nikesha_gilmore@urmc.rochester.edu', 'phone': '1-585-275-1275', 'title': 'Dr. Nikesha Gilmore, Assistant Professor', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': "No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions.", 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Indigestion/Dyspesia - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gas/Flatulence - Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gas/Flatulence - Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment Feasibility: Rates of Consent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Participants Consented', 'description': 'Proportion of participants approached compared to those consented onto the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.375', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Since this outcome measure looks at the number of participants approached versus consented, the number of participants analyzed was the 64 approached instead of the 14 that were randomized.'}, {'type': 'PRIMARY', 'title': 'Recruitment Feasibility: Rates of Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Participants Randomized', 'description': 'Proportion of participants consented compared to those randomized onto the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.583', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Since this outcome measure looks at the number of participants consented versus randomized, the number of participants analyzed was the 24 consented instead of the 14 that were randomized.'}, {'type': 'PRIMARY', 'title': 'The Proportion of Participants That Completed the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': "No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week', 'description': 'To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Proportion of Participants That Were Adherent to the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.857', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week', 'description': 'To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \\>70% of study drug).', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety of the EGCG Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': "No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions."}], 'classes': [{'title': 'Gas/Flatulence-Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gas/Flatulence-Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation-Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea-Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion/Dyspepsia-Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea-Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia-Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': "No study pills. Followed Usual Care procedures for a survivor of cancer according to oncology care teams' directions."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients were recruited from clinical sites within Wilmot Cancer Institute between April 2021 and March 2023. Eligible patients were aged 65 or older, diagnosed with Stage I-III solid cancer, completed curative intent treatment 10 years or less before being screened, and had a Fried's Frailty Score (FFS ≥ 2); assessed by measuring grip strength, weight loss, physical activity, fatigue, and a 4-meter walk test. The first participant was consented on April 28, 2021, and randomized on May 6, 2021.", 'preAssignmentDetails': "Sixty four (64) potentially eligible participants were approached and 24 participants were consented. Of the 24 consented subjects: 5 screen failed (participant was consented but didn't fully meet eligibility criteria e.g. meet frailty cut off or liver toxicity screen); 4 screen withdrew (participant was consented but withdrew from the study before the baseline visit for randomization), and 1 was lost to follow up. Fourteen (14) participants were randomized to the treatment groups."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day\n\nEpigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C): 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': "No study pills. Followed Usual Care procedures for an older survivor of cancer according to oncology care teams' directions."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age, Years: Mean', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '90'}, {'value': '72.6', 'groupId': 'BG001', 'lowerLimit': '66', 'upperLimit': '80'}, {'value': '74.5', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Some College', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'College and Above', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Married', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unmarried', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'categories': [{'title': 'Retired', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Employed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Stage', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Stage II', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Cancer stage was reviewed from the patient's medical records and confirmed with their provider to ensure eligibility.\n\nStage 0: abnormal cells are present and have not spread to nearby tissue. Stage 1: the cancer is small and contained within the organ it started in. Stage 2: the cancer has grown and possibly spread to nearby lymph nodes. Stage 3: the cancer has grown more and has spread to surrounding tissues including nearby lymph nodes.\n\nStage 4: the cancer had spread to distant parts of the body.", 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Type', 'classes': [{'categories': [{'title': 'Colon/Rectal/Anal', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Breast', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Prostate', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Treatment', 'classes': [{'categories': [{'title': 'Surgery Alone', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Surgery with Chemotherapy', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Surgery with Radiation', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There were 14 subjects whose baseline measurements were received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-20', 'size': 1133268, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-06T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2020-09-04', 'resultsFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-03', 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Feasibility: Rates of Consent', 'timeFrame': 'Baseline', 'description': 'Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.'}, {'measure': 'Recruitment Feasibility: Rates of Randomization', 'timeFrame': 'Baseline', 'description': 'Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.'}, {'measure': 'The Proportion of Participants That Completed the Study', 'timeFrame': '12 week', 'description': 'To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.'}, {'measure': 'The Proportion of Participants That Were Adherent to the Intervention', 'timeFrame': '12 week', 'description': 'To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \\>70% of study drug).'}, {'measure': 'Safety of the EGCG Intervention', 'timeFrame': '12 weeks', 'description': 'Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be age 65 or over.\n2. Be diagnosed with stage I-III Cancer.\n3. Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.)\n4. Have a Fried's Frailty Score (FFS) of ≥ 2.\n5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control guidelines.\n\nExclusion Criteria: Study subjects must not:\n\n1. Have chemotherapy planned for the during of the study.\n2. Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).\n3. Have uncontrolled or unmanaged liver disease.\n4. Consume more than 6 cups of green tea per day.\n5. Have known allergies to caffeine.\n6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.\n7. Be diagnosed with dementia.\n8. Cannot provide informed consent due to lack of decision making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines."}, 'identificationModule': {'nctId': 'NCT04553666', 'acronym': 'ReFOCUS', 'briefTitle': 'Reducing Frailty for Older Cancer Survivors Using Supplements', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer', 'orgStudyIdInfo': {'id': 'UCCS20081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day', 'interventionNames': ['Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': 'No study pills'}], 'interventions': [{'name': 'Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)', 'type': 'DRUG', 'otherNames': ['EGCG plus Vitamin C'], 'description': '800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14627', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nikesha Gilmore', 'investigatorAffiliation': 'University of Rochester'}}}}