Effects of Short-term Fasting on Tolerance to Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Leiden University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Bronovo Hospital
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01304251
First received: February 24, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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


Condition Intervention
Breast Cancer
Other: Short-term fasting
Other: Healthy nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • chemotherapy-induced neutropenia [ Time Frame: approximately 126 days ] [ Designated as safety issue: No ]
    Neutrophil count after 6 cycles of chemotherapy (6x 21 days)


Secondary Outcome Measures:
  • chemotherapy-induced DNA damage in leukocytes [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)

  • perceived side effects of chemotherapy [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304251

Contacts
Contact: Hanno Pijl, MD PhD 0031715263738 H.Pijl@lumc.nl
Contact: Judith R Kroep, MD PhD 0031715265095 J.R.Kroep@lumc.nl

Locations
Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Hanno Pijl, MD PhD    00715263738    H.Pijl@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Bronovo Hospital
Investigators
Principal Investigator: Hanno Pijl, MD PhD Leiden University Medical Center
  More Information

Publications:
Responsible Party: Professor H. Pijl, MD PhD, Leiden Universiry Medical Center
ClinicalTrials.gov Identifier: NCT01304251     History of Changes
Other Study ID Numbers: P10.247
Study First Received: February 24, 2011
Last Updated: February 24, 2011
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Leiden University Medical Center:
short-term fasting
adjuvant chemotherapy
toxicity
side-effects

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014