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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04141514
Other study ID # 2019/CHU/03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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