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

September 5, 2019 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Usual care
Drug: Placebos
NaCl 0,9% (IV infusion)
Active Comparator: Selenium
Usual care + selenium 300 µg/day (IV infusion)
Drug: Selenium
Selenium 300 µg/day (IV infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe oral mucositis (grade 3-4)
Time Frame: 31 months
31 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of any grade oral mucositis
Time Frame: 31 months
31 months
Number of days with severe oral mucositis
Time Frame: 31 months
31 months
Incidence of infectious complications
Time Frame: 31 months
31 months
Number of days with artifical nutrition
Time Frame: 31 months
31 months
Number of days with opioids
Time Frame: 31 months
31 months
Duration of hospitalization
Time Frame: 31 months
31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-005033-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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