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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2025-06-19

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).

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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.

Conditions

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Nausea Post Chemotherapy Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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intervention group

therapeutic fasting

Group Type EXPERIMENTAL

therapeutic fasting

Intervention Type OTHER

fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)

control group

usual alimentation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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therapeutic fasting

fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No