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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

February 24, 2011
February 24, 2011
March 2011
April 2012   (final data collection date for primary outcome measure)
chemotherapy-induced neutropenia [ Time Frame: approximately 126 days ] [ Designated as safety issue: No ]
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Short-term Fasting on Tolerance to Chemotherapy
Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • Other: Short-term fasting
    Short-term fasting, i.e. 24 hours before and 24 hours after 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.
  • 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
    Intervention: Other: Short-term fasting
  • 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.
    Intervention: Other: Healthy nutrition
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Hanno Pijl, MD PhD 0031715263738 H.Pijl@lumc.nl
Contact: Judith R Kroep, MD PhD 0031715265095 J.R.Kroep@lumc.nl
Netherlands
 
NCT01304251
P10.247
No
Professor H. Pijl, MD PhD, Leiden Universiry Medical Center
Leiden University Medical Center
Bronovo Hospital
Principal Investigator: Hanno Pijl, MD PhD Leiden University Medical Center
Leiden University Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP