Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy (CHEMO-FAST)

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).

Study Overview

• Status: Recruiting
• Conditions: Vomiting; Nausea Post Chemotherapy
• Intervention / Treatment: Other: therapeutic fasting

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mélanie BEGORRE; Phone Number: +262 (0)262 90 78 85; Email: melanie.begorre@chu-reunion.fr

Study Locations

• France
  • Saint-Pierre, France, 97410
    • Recruiting
    • CHU de la Réunion
    • Contact: ELORA MUSSARD; Phone Number: 0262358759; Email: elora.grondin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; therapeutic fasting	Other: 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)
No Intervention: control group; usual alimentation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Marie-Elora MUSSARD, CHU de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): November 19, 2024
• Study Completion (Estimated): June 19, 2025

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 2019/CHU/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No