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

Sponsor
University Hospital, Angers (Other)
Overall Status
Unknown status
CT.gov ID
NCT04080622
Collaborator
(none)
110
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Incidence of severe oral mucositis (grade 3-4) [31 months]

Secondary Outcome Measures

  1. Incidence of any grade oral mucositis [31 months]

  2. Number of days with severe oral mucositis [31 months]

  3. Incidence of infectious complications [31 months]

  4. Number of days with artifical nutrition [31 months]

  5. Number of days with opioids [31 months]

  6. Duration of hospitalization [31 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04080622
Other Study ID Numbers:
  • 2018-005033-21
First Posted:
Sep 6, 2019
Last Update Posted:
Sep 6, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Mucositis
Stomatitis
Selenium

Study Results

No Results Posted as of Sep 6, 2019