Clinical trial · Interventional
Effects of Short-term Fasting on Tolerance to Chemotherapy
Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
NCT01304251CI-TRIAL-00020491completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthy nutrition | Other | — | UNRESOLVED |
| Short-term fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
- chemotherapy-induced neutropenia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female breast cancer patients, receiving adjuvant TAC-chemotherapy * Age ≥ 18 years old * WHO performance status 0-2 * Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l * 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 * Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min * Survival expectation \> 3 months * Patients must be accessible for treatment and follow-up * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * Diabetes Mellitus * body mass index (BMI) \< 19 kg/m2 * Pregnancy or lactating * 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
References
Publications (2)
- RESULTSafdie 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 20157582
- DERIVEDde 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. PMID 26438237