Nausea Post Chemotherapy, Vomiting
Conditions
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.
Interventions
OTHERtherapeutic fasting
fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)
Sponsors
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nausea and vomiting evaluation and quantification | Day 1 (first day of the chemotherapy cycle), | Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer) |
Countries
France
Contacts
Primary ContactMélanie BEGORRE
Outcome results
None listed