Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
18 Years
N/A
Female
Breast Cancer
Trial Information
Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
chemotherapy-induced neutropenia
Outcome Description:
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
Outcome Time Frame:
approximately 126 days
Safety Issue:
No
Principal Investigator
Hanno Pijl, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leiden University Medical Center
Authority:
Netherlands: Ministry of Health, Welfare and Sport
Study ID:
P10.247
NCT ID:
NCT01304251
Start Date:
March 2011
Completion Date:
April 2012
Related Keywords:
- Breast Cancer
- short-term fasting
- adjuvant chemotherapy
- toxicity
- side-effects
- Breast Neoplasms
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