NCT04080622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

September 2, 2019

Last Update Submit

December 26, 2024

Conditions

Mucositis OralStem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe oral mucositis (grade 3-4)

    31 months

Secondary Outcomes (6)

  • Incidence of any grade oral mucositis

    31 months

  • Number of days with severe oral mucositis

    31 months

  • Incidence of infectious complications

    31 months

  • Number of days with artifical nutrition

    31 months

  • Number of days with opioids

    31 months

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Usual care

Drug: Placebos

Selenium

ACTIVE COMPARATOR

Usual care + selenium 300 µg/day (IV infusion)

Drug: Selenium

Interventions

SeleniumDRUG

Selenium 300 µg/day (IV infusion)

Selenium
PlacebosDRUG

NaCl 0,9% (IV infusion)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, Maine et Loire, 49933, France

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Selenium

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 6, 2019

Study Start

October 10, 2019

Primary Completion

October 8, 2023

Study Completion

October 31, 2023

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations

FR(1)