Effects of Short-term Fasting on Tolerance to Chemotherapy

• ClinicalTrials.gov Identifier: NCT01304251
• Recruitment Status: Completed
• First Posted: February 25, 2011
• Last Update Posted: January 12, 2016
• Sponsor: Leiden University Medical Center
• Information provided by (Responsible Party): Hanno Pijl, Leiden University Medical Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: Short-term fasting; Other: Healthy nutrition	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
• Study Start Date: March 2011
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Short-term fasting; short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients	Other: Short-term fasting; Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
Placebo Comparator: Healthy nutrition; 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. chemotherapy-induced neutropenia [ Time Frame: approximately 126 days ]
   Neutrophil count after 6 cycles of chemotherapy (6x 21 days)

Secondary Outcome Measures :

1. chemotherapy-induced DNA damage in leukocytes [ Time Frame: 21 days ]
   chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)
2. perceived side effects of chemotherapy [ Time Frame: 21 days ]
   To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)
3. effect of short-term fasting on the body's inflammatory response to chemotherapy [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

Leiden University Medical Center

Leiden, Netherlands

Sponsors and Collaborators

Leiden University Medical Center

Investigators

• Principal Investigator: Hanno Pijl, MD PhD; Leiden University Medical Center

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de 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.

• Responsible Party: Hanno Pijl, Prof. dr. H. Pijl, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT01304251 History of Changes
• Other Study ID Numbers: P10.247
• First Posted: February 25, 2011
• Last Update Posted: January 12, 2016
• Last Verified: January 2016

Keywords provided by Hanno Pijl, Leiden University Medical Center:

short-term fasting; adjuvant chemotherapy; toxicity; side-effects

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases