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

Vomiting Clinical Trial

— CHEMO-FAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141514
• Other study ID #: 2019/CHU/03
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: June 19, 2025

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Mélanie BEGORRE
• Phone: +262 (0)262 90 78 85
• Email: melanie.begorre[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 19, 2025
• Est. primary completion date: November 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Nausea Post Chemotherapy
• Vomiting

Intervention

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)

Locations

Country	Name	City	State
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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),
Primary	nausea and vomiting evaluation and quantification	Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)	day 2 of the chemotherapy cycle
Primary	nausea and vomiting evaluation and quantification	Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)	day 3 of the chemotherapy cycle
Primary	nausea and vomiting evaluation and quantification	Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)	day 4 of the chemotherapy cycle
Primary	nausea and vomiting evaluation and quantification	Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)	day 5 of the chemotherapy cycle