Mucositis Oral, Stem Cell Transplant Complications
Conditions
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.
Interventions
DRUGSelenium
Selenium 300 µg/day (IV infusion)
DRUGPlacebos
NaCl 0,9% (IV infusion)
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis (grade 3-4) | 31 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of days with severe oral mucositis | 31 months |
| Incidence of infectious complications | 31 months |
| Incidence of any grade oral mucositis | 31 months |
| Number of days with opioids | 31 months |
| Duration of hospitalization | 31 months |
| Number of days with artifical nutrition | 31 months |
Countries
France
Outcome results
None listed