Breast Cancer
Conditions
Keywords
short-term fasting, adjuvant chemotherapy, toxicity, side-effects
Brief summary
The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients
Detailed description
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.
Interventions
OTHERShort-term fasting
Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
OTHERHealthy nutrition
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.
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy-induced neutropenia | approximately 126 days | Neutrophil count after 6 cycles of chemotherapy (6x 21 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy-induced DNA damage in leukocytes | 21 days | chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days) |
| perceived side effects of chemotherapy | 21 days | To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days) |
| effect of short-term fasting on the body's inflammatory response to chemotherapy | 21 days | 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 |
Countries
Netherlands
Outcome results
None listed