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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neoplasia, Cancer, Fasting

Intervention / Treatment
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* Behavioral: initial fasting
* Behavioral: Secondary fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial fasting<br>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<br>* 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<br>|
| Active Comparator: Secondary fasting<br>Fasting during the second half of chemotherapy cycles (3 and 4 of four cycles or 4 to 6 of six cycles) | Behavioral: Secondary fasting<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, modified FACT-O |  | 24 h and 7 days after chemotherapy cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short-term fasting, adjuvant chemotherapy, toxicity, side-effects, ovarial carinoma, breast cancer