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

University Hospital, Angers

Status and phase: Completed; Phase 3

Conditions: Mucositis Oral; Stem Cell Transplant Complications

Treatments: Drug: Selenium; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04080622

2018-005033-21

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Usual care

Treatment:

Drug: Placebos

Selenium

Active Comparator group

Description:

Usual care + selenium 300 µg/day (IV infusion)

Treatment:

Drug: Selenium