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Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial (FIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01954836
First received: September 29, 2013
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
Hypothesis: Fasting before (48h) and one day after chemotherapy may protect normal cells from the adverse effects of chemotherapy. Design: Within a randomized controlled pilot trial 30 female patients with gynecological cancer (ovarian and breast cancer)and 4-6 scheduled chemotherapies will be randomized to fast 60-72 hours during the first half of chemotherapies or during the second half of chemotherapies and to proceed normocaloric food intake during the other cycles.Sequence of fasting and normocaloric food intake will be randomized. Assessments of adverse effects, quality of life and laboratory values take place 24 and 7 days after each chemotherapy. Statistical analyses compare summarized differences of fasted and non-fasted chemotherapy cycles.

Condition Intervention
Neoplasia Cancer Fasting Behavioral: initial fasting Behavioral: Secondary fasting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial

Further study details as provided by Andreas Michalsen, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Quality of life, modified FACT-O [ Time Frame: 24 h and 7 days after chemotherapy cycle ]

Secondary Outcome Measures:
  • Fatigue [ Time Frame: 24 h and 7 days after chemotherapy cycle ]
  • Intensity of adverse effects structured criteria Likert scales [ Time Frame: 24 h and 7 days after chemotherapy cycles ]
  • Laboratory assessments (blood count, liver, renal function) [ Time Frame: 24 h and 7 days after chemotherapy cycles ]

Enrollment: 50
Study Start Date: October 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Initial fasting
Fasting during chemotherapy of the first half of chemotherapy cycles (1 and 2 of four or 1 to 3 of six cycles)
Behavioral: initial fasting
modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the first half of scheduled 4 or 6 chemotherapy cycles
Active Comparator: Secondary fasting
Fasting during the second half of chemotherapy cycles (3 and 4 of four cycles or 4 to 6 of six cycles)
Behavioral: Secondary fasting
modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the second half of scheduled 4 or 6 chemotherapy cycles

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 may reduce the severity of adverse effects caused by chemotherapy, without interfering with its anti-tumoral effects. A first case series of 10 cancer patients, suggested that short-term fasting may also protect against the side effects of chemotherapy in humans. This study aims to further evaluate the impact of short-term fasting on tolerance to chemotherapy in humans.Within a randomized controlled pilot trial 30 female patients with gynecological cancer disease (ovarian and breast cancer)in all stages and 4-6 scheduled chemotherapies will be randomized to fast 60-72 hours during half of chemotherapies and to have normocaloric food intake during the other chemotherapies. Fasting is defined as caloric restriction to below 400kcal energy intake/day with free intake of water and tea. Sequences of fasting and normocaloric food intake will be randomized. Assessments of adverse effects, quality of life, fatigue and laboratory values will take place 24 and 7 days after each chemotherapy. Statistical analyses will compare the summarized differences of fasted and non-fasted chemotherapy cycles, that means a total of max. 60-90 chemotherapies with accompanying fasting will be compared to 60-90 non-fasted chemotherapies.
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ovarian cancer or breast cancer
  • scheduled chemotherapy
  • First diagnosis or 1.recurrence

mono

Exclusion Criteria:

  • cachexia (BMI < 21kg/m2)
  • eating disorder
  • renal failure (Crea >2mg/dl)
  • enterostoma
  • short bowel syndrome
  • not assigned to other studies
  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: NCT01954836

Locations
Germany
Charite University
Berlin, Germany, 14109
Charite University
Berlin, Germany, 14169
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: andreas A Michalsen, M.D. Charite University
  More Information

Responsible Party: Andreas Michalsen, Prof.Dr.med Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01954836     History of Changes
Other Study ID Numbers: FIT08/2013
Study First Received: September 29, 2013
Last Updated: December 12, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
short-term fasting
adjuvant chemotherapy
toxicity
side-effects
ovarial carinoma
breast cancer

ClinicalTrials.gov processed this record on June 22, 2017