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

Stem Cell Transplant Complications Clinical Trial

— AutoSelenium  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04080622
• Other study ID #: 2018-005033-21
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2019
• Est. completion date: May 2022

Study information

• Verified date: September 2019
• Source: University Hospital, Angers
• Contact: Corentin Orvain, MD
• Phone: 33241354475
• Email: corentin.orvain[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stem Cell Transplant Complications

Intervention

Drug:
• Selenium
Selenium 300 µg/day (IV infusion)
• Placebos
NaCl 0,9% (IV infusion)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe oral mucositis (grade 3-4)		31 months
Secondary	Incidence of any grade oral mucositis		31 months
Secondary	Number of days with severe oral mucositis		31 months
Secondary	Incidence of infectious complications		31 months
Secondary	Number of days with artifical nutrition		31 months
Secondary	Number of days with opioids		31 months
Secondary	Duration of hospitalization		31 months