Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy (CHEMO-FAST)
Primary Purpose
Nausea Post Chemotherapy, Vomiting
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic fasting
Sponsored by
About this trial
This is an interventional other trial for Nausea Post Chemotherapy
Eligibility Criteria
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
Sites / Locations
- CHU de la RéunionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
therapeutic fasting
usual alimentation
Outcomes
Primary Outcome Measures
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Secondary Outcome Measures
Full Information
NCT ID
NCT04141514
First Posted
October 23, 2019
Last Updated
January 28, 2021
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT04141514
Brief Title
Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
Acronym
CHEMO-FAST
Official Title
Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea Post Chemotherapy, Vomiting
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
therapeutic fasting
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual alimentation
Intervention Type
Other
Intervention Name(s)
therapeutic fasting
Intervention Description
fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)
Primary Outcome Measure Information:
Title
nausea and vomiting evaluation and quantification
Description
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Time Frame
Day 1 (first day of the chemotherapy cycle),
Title
nausea and vomiting evaluation and quantification
Description
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Time Frame
day 2 of the chemotherapy cycle
Title
nausea and vomiting evaluation and quantification
Description
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Time Frame
day 3 of the chemotherapy cycle
Title
nausea and vomiting evaluation and quantification
Description
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Time Frame
day 4 of the chemotherapy cycle
Title
nausea and vomiting evaluation and quantification
Description
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Time Frame
day 5 of the chemotherapy cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie BEGORRE
Phone
+262 (0)262 90 78 85
Email
melanie.begorre@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Elora MUSSARD
Organizational Affiliation
CHU de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ELORA MUSSARD
Phone
0262358759
Email
elora.grondin@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
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