Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy

Study Overview
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Brief Summary
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This study aims to estimate the effect of the practice of a short-term partial fasting compared to a usual alimentation on nausea and vomiting within 5 days after the start of a chemotherapy session on 2 successive chemotherapy courses (4 sessions of chemotherapy) in patients starting treatment with highly emetogenic chemotherapy (ABVD or AVD protocol).

Detailed Description
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Patients in fasting arm will practice partial fasting during 3 days (D-1, D1 (D day of chemotherapy) and D2) following a food guide during 4 chemotherapy sessions. Patients in usual alimentation arm will continue to take food as usual practice. In each arm, patients will be interviewed at each chemotherapy sessions about nausea and vomiting (number and intensity of nausea and vomiting, treatments taken). Denutrition, quality of life improvement, compliance to partial fasting, treatment response will be evaluate too.

Official Title
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Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy

Conditions
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Nausea Post Chemotherapy, Vomiting

Intervention / Treatment
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* Other: therapeutic fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient starting a treatment by chemotherapy ABVD or AVD patient affiliated to a social security scheme patient who gives his informed consent before any procedure related to the study Exclusion Criteria: patient with diabetes patient with recent gastric ulcer patient with low BMI (less than 18,5 for patients under 70 or less than 21 for patient over 70) albuminemia <35 patient wiht loss weight > 10% in 6 months pregnant or lactating women chronic alcoholism unable to understand the objectives and risks of the study patient with psychiatric desorder, under guardianship or under judicial protection patient who cannot read

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>therapeutic fasting | Other: therapeutic fasting<br>* fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)<br>|
| No Intervention: control group<br>usual alimentation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and vomiting evaluation and quantification | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) | Day 1 (first day of the chemotherapy cycle), | 
| nausea and vomiting evaluation and quantification | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) | day 2 of the chemotherapy cycle | 
| nausea and vomiting evaluation and quantification | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) | day 3 of the chemotherapy cycle | 
| nausea and vomiting evaluation and quantification | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) | day 4 of the chemotherapy cycle | 
| nausea and vomiting evaluation and quantification | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) | day 5 of the chemotherapy cycle |