NCT04080622

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucositis Oral
• Stem Cell Transplant Complications

Interventions

Type	Name	Description
DRUG	Selenium	Selenium 300 µg/day (IV infusion)
DRUG	Placebos	NaCl 0,9% (IV infusion)

Timeline

• Start date: 2019-10-10
• Primary completion: 2023-10-08
• Completion: 2023-10-31
• First posted: 2019-09-06
• Last updated: 2024-12-30

Locations

1 site across 1 country: France