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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01954836

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neoplasia Cancer Fasting	Behavioral: initial fasting Behavioral: Secondary fasting	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Quality of life, modified FACT-O [24 h and 7 days after chemotherapy cycle]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Charite University	Berlin		Germany	14109
2	Charite University	Berlin		Germany	14169

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator: andreas A Michalsen, M.D., Charite University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andreas Michalsen, Prof.Dr.med Andreas Michalsen, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01954836

Other Study ID Numbers:

FIT08/2013

First Posted:

Oct 7, 2013

Last Update Posted:

Dec 13, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Andreas Michalsen, Prof.Dr.med Andreas Michalsen, Charite University, Berlin, Germany

short-term fasting

adjuvant chemotherapy

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Dec 13, 2016