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Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy (CHEMO-FAST)

C

Centre Hospitalier Universitaire de la Réunion

Status

Enrolling

Conditions

Vomiting
Nausea Post Chemotherapy

Treatments

Other: therapeutic fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT04141514
2019/CHU/03

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

intervention group
Experimental group
Description:
therapeutic fasting
Treatment:
Other: therapeutic fasting
control group
No Intervention group
Description:
usual alimentation

Trial contacts and locations

1

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Central trial contact

Mélanie BEGORRE

Data sourced from clinicaltrials.gov

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