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Completed

NCT Number: NCT04080622

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.

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Key information

Conditions

Mucositis Oral Mouth Diseases Stem Cell Transplant Complications Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Angers

Angers, Maine et Loire, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

selenium

Drug

Selenium 300 µg/day (IV infusion)

Placebos

Drug

NaCl 0,9% (IV infusion)

Primary outcomes

  1. Incidence of severe oral mucositis (grade 3-4)

    Time frame: 31 months

Secondary outcomes

  1. Incidence of any grade oral mucositis

    Time frame: 31 months

  2. Number of days with severe oral mucositis

    Time frame: 31 months

  3. Incidence of infectious complications

    Time frame: 31 months

  4. Number of days with artifical nutrition

    Time frame: 31 months

  5. Number of days with opioids

    Time frame: 31 months

  6. Duration of hospitalization

    Time frame: 31 months

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: AutoSelenium

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2019
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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