Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
CHEMO-FAST
1 other identifier
interventional
30
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2025
CompletedOctober 31, 2023
October 1, 2023
2.8 years
October 23, 2019
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
intervention group
EXPERIMENTALtherapeutic fasting
control group
NO INTERVENTIONusual alimentation
Interventions
fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de la Réunion
Saint-Pierre, 97410, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Elora MUSSARD
CHU de La Réunion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 28, 2019
Study Start
January 20, 2022
Primary Completion
November 19, 2024
Study Completion
June 19, 2025
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share