Effects of Short-term Fasting on Tolerance to Chemotherapy

Breast Cancer Clinical Trial

Official title:

Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304251
• Other study ID #: P10.247
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: January 9, 2016
• Start date: March 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Short-term fasting
Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
• Healthy 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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemotherapy-induced neutropenia	Neutrophil count after 6 cycles of chemotherapy (6x 21 days)	approximately 126 days	No
Secondary	chemotherapy-induced DNA damage in leukocytes	chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)	21 days	No
Secondary	perceived side effects of chemotherapy	To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)	21 days	No
Secondary	effect of short-term fasting on the body's inflammatory response to chemotherapy	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	21 days	No