Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01304251
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2011-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Short-term Fasting on Tolerance to Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072001', 'term': 'Diet, Healthy'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-09', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chemotherapy-induced neutropenia', 'timeFrame': 'approximately 126 days', 'description': 'Neutrophil count after 6 cycles of chemotherapy (6x 21 days)'}], 'secondaryOutcomes': [{'measure': 'chemotherapy-induced DNA damage in leukocytes', 'timeFrame': '21 days', 'description': 'chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)'}, {'measure': 'perceived side effects of chemotherapy', 'timeFrame': '21 days', 'description': 'To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)'}, {'measure': "effect of short-term fasting on the body's inflammatory response to chemotherapy", 'timeFrame': '21 days', 'description': "To determine the effect of short-term fasting on the body's inflammatory response to chemotherapy, inflammation parameters will be measured after each cycle of chemotherapy"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['short-term fasting', 'adjuvant chemotherapy', 'toxicity', 'side-effects'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20157582', 'type': 'RESULT', 'citation': 'Safdie FM, Dorff T, Quinn D, Fontana L, Wei M, Lee C, Cohen P, Longo VD. Fasting and cancer treatment in humans: A case series report. Aging (Albany NY). 2009 Dec 31;1(12):988-1007. doi: 10.18632/aging.100114.'}, {'pmid': '26438237', 'type': 'DERIVED', 'citation': 'de Groot S, Vreeswijk MP, Welters MJ, Gravesteijn G, Boei JJ, Jochems A, Houtsma D, Putter H, van der Hoeven JJ, Nortier JW, Pijl H, Kroep JR. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study. BMC Cancer. 2015 Oct 5;15:652. doi: 10.1186/s12885-015-1663-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients', 'detailedDescription': 'Evidence from experimental animals provides strong support for the concept that caloric restriction (CR) increases resistance to multiple forms of stress. CR decreases plasma levels of growth factors, e.g. insulin-like growth factor-I (IGF-I), thereby diverting energy from growth to maintenance. Accordingly, the currently available information suggests that short-term fasting protects normal cells against the perils of (high dose) chemotherapy. In contrast, cancer cells are not (or less) protected as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of side-effects caused by the toxicity of chemotherapy, without interfering with its effect on reduction of tumour volume or tumour markers. A recent report, sketching a case series of 10 cancer patients, suggests that short term fasting protects against the side effects of chemotherapy in humans. Indeed, the majority of patients preferred fasting over feeding in preparation of their therapy. This study aims to further evaluate the impact of fasting on tolerance to chemotherapy in humans.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female breast cancer patients, receiving adjuvant TAC-chemotherapy\n* Age ≥ 18 years old\n* WHO performance status 0-2\n* Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l\n* Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL\n* Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min\n* Survival expectation \\> 3 months\n* Patients must be accessible for treatment and follow-up\n* Written informed consent according to the local Ethics Committee requirements\n\nExclusion Criteria:\n\n* Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias\n* Diabetes Mellitus\n* body mass index (BMI) \\< 19 kg/m2\n* Pregnancy or lactating\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent'}, 'identificationModule': {'nctId': 'NCT01304251', 'briefTitle': 'Effects of Short-term Fasting on Tolerance to Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'P10.247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short-term fasting', 'description': 'short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients', 'interventionNames': ['Other: Short-term fasting']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy nutrition', 'description': '20 breast cancer patients eat according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy.', 'interventionNames': ['Other: Healthy nutrition']}], 'interventions': [{'name': 'Short-term fasting', 'type': 'OTHER', 'description': 'Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy', 'armGroupLabels': ['Short-term fasting']}, {'name': 'Healthy nutrition', 'type': 'OTHER', 'description': 'Eating according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy. Dietary instructions will be given by a dietician and actual food intake will be recorded in a journal.', 'armGroupLabels': ['Healthy nutrition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Hanno Pijl, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. H. Pijl', 'investigatorFullName': 'Hanno Pijl', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}