Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Leiden University Medical Center

Hanno Pijl, MD PhD

Principal Investigator

Hanno Pijl, MD PhD		Ph: 0031715263738
		Email: H.Pijl@lumc.nl

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01304251
Information obtained from ClinicalTrials.gov on November 20, 2012