drugset / Trial / NCT04080622

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

NCT04080622

Phase 3 Completed 100 enrolled University Hospital, Angers
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2019-10-10
Primary completion
2023-10-08
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Selenium Other / unclassified 300 ug Intravenous