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Effects of Short-term Fasting on Tolerance to Chemotherapy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Short-term fasting
Healthy nutrition
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring short-term fasting, adjuvant chemotherapy, toxicity, side-effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Short-term fasting

Healthy nutrition

Arm Description

short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients

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.

Outcomes

Primary Outcome Measures

chemotherapy-induced neutropenia
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)

Secondary Outcome Measures

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)
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)
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

Full Information

First Posted
February 24, 2011
Last Updated
January 9, 2016
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01304251
Brief Title
Effects of Short-term Fasting on Tolerance to Chemotherapy
Official Title
Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
short-term fasting, adjuvant chemotherapy, toxicity, side-effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short-term fasting
Arm Type
Active Comparator
Arm Description
short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients
Arm Title
Healthy nutrition
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Short-term fasting
Intervention Description
Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
Intervention Type
Other
Intervention Name(s)
Healthy nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
chemotherapy-induced neutropenia
Description
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
Time Frame
approximately 126 days
Secondary Outcome Measure Information:
Title
chemotherapy-induced DNA damage in leukocytes
Description
chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)
Time Frame
21 days
Title
perceived side effects of chemotherapy
Description
To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)
Time Frame
21 days
Title
effect of short-term fasting on the body's inflammatory response to chemotherapy
Description
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
Time Frame
21 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanno Pijl, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20157582
Citation
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. doi: 10.18632/aging.100114.
Results Reference
result
PubMed Identifier
26438237
Citation
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.
Results Reference
derived

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Effects of Short-term Fasting on Tolerance to Chemotherapy

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