Nausea Post ChemotherapyCHEMO-FASTNCT04141514
Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
A study testing therapeutic fasting in people with Nausea Post Chemotherapy and Vomiting, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea Post Chemotherapy, Vomiting
- What is being tested?
- therapeutic fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2022to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de la Réunion
Saint-Pierre, 97410
ELORA MUSSARD, 0262358759, elora.grondin@gmail.com
About this study
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).
Read the 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.
- Conditions
- Nausea Post Chemotherapy, Vomiting
- Being tested
- therapeutic fasting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic fastingOther
fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | therapeutic fasting Receives: Other: therapeutic fasting |
| control group | No intervention | usual alimentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Measured: 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)
Measured: day 2 of the chemotherapy cycle
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Measured: day 3 of the chemotherapy cycle
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Measured: day 4 of the chemotherapy cycle
nausea and vomiting evaluation and quantification
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Measured: day 5 of the chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start20 Jan 2022
- Primary completion19 Nov 2024 (estimated)
- Study completion19 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea Post ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Elora MUSSARD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141514
- Sponsor's protocol ID
- 2019/CHU/03
- Acronym
- CHEMO-FAST
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2019
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy
- ClinicalTrials.gov ID
- NCT04141514
- Acronym / sponsor ID
- CHEMO-FAST / 2019/CHU/03
- Conditions
- Nausea Post Chemotherapy, Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 19 Nov 2024 (estimated)
- Study completion
- 19 Jun 2025 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: therapeutic fastingtherapeutic fasting |
| control group | No intervention | –usual alimentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic fastingfasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy) | Other | intervention group |
Primary outcome
nausea and vomiting evaluation and quantification
Time frame: Day 1 (first day of the chemotherapy cycle),
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Time frame: day 2 of the chemotherapy cycle
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Time frame: day 3 of the chemotherapy cycle
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Time frame: day 4 of the chemotherapy cycle
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
nausea and vomiting evaluation and quantification
Time frame: day 5 of the chemotherapy cycle
Anti-emetic tool from MASCC (Multinational Association of Supportive Care in Cancer)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Elora MUSSARD principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic fasting in people with Nausea Post Chemotherapy and Vomiting, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mélanie BEGORRE (+262 (0)262 90 78 85, melanie.begorre@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nausea and vomiting evaluation and quantification (time frame: Day 1 (first day of the chemotherapy cycle),). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.