Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
Phase 3
Completed
- Conditions
- Mucositis OralStem Cell Transplant Complications
- Interventions
- Drug: Placebos
- Registration Number
- NCT04080622
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos Usual care Selenium Selenium Usual care + selenium 300 µg/day (IV infusion)
- Primary Outcome Measures
Name Time Method Incidence of severe oral mucositis (grade 3-4) 31 months
- Secondary Outcome Measures
Name Time Method Incidence of any grade oral mucositis 31 months Number of days with artifical nutrition 31 months Number of days with severe oral mucositis 31 months Incidence of infectious complications 31 months Number of days with opioids 31 months Duration of hospitalization 31 months
Trial Locations
- Locations (1)
CHU Angers
🇫🇷Angers, Maine et Loire, France