ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Short-term Fasting on Tolerance to Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01304251
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Hanno Pijl, Leiden University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304251


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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

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    Key Record Dates
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