CompletedPhase 3

Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

France100 participantsStarted 2019-10-10

Plain-language summary

Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma. * Signed informed consent. Exclusion Criteria: * Autologous stem cell transplantation for another medical condition than lymphoma or myéloma. * Intolerance to selenium. * High selenium levels before study. * Pregnancy or patients breast-feeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of severe oral mucositis (grade 3-4)

Timeframe: 31 months

Trial details

NCT IDNCT04080622

SponsorUniversity Hospital, Angers

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-10-08

View on ClinicalTrials.gov More Mucositis Oral trials