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

NCT04080622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-30

No results posted yet for this study

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

DRUG

Selenium

Selenium 300 µg/day (IV infusion)

DRUG

Placebos

NaCl 0,9% (IV infusion)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080622 on ClinicalTrials.gov