Mucositis OralPhase 3AutoSeleniumNCT04080622
Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
A Phase 3 study testing Selenium in people with Mucositis Oral and Stem Cell Transplant Complications, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis Oral, Stem Cell Transplant Complications
- What is being tested?
- Selenium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2019to 31 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mucositis Oral, Stem Cell Transplant Complications
- Being tested
- Selenium, Placebos
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDrug
Selenium 300 µg/day (IV infusion)
PlacebosDrug
NaCl 0,9% (IV infusion)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Usual care Receives: Drug: Placebos |
| Selenium | Active comparator | Usual care + selenium 300 µg/day (IV infusion) Receives: Drug: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe oral mucositis (grade 3-4)
Measured: 31 months
Secondary outcomes (6)
Incidence of any grade oral mucositis
Measured: 31 months
Number of days with severe oral mucositis
Measured: 31 months
Incidence of infectious complications
Measured: 31 months
Number of days with artifical nutrition
Measured: 31 months
Number of days with opioids
Measured: 31 months
Duration of hospitalization
Measured: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start10 Oct 2019
- Primary completion8 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080622
- Sponsor's protocol ID
- 2018-005033-21
- Other IDs
- 2018
- Acronym
- AutoSelenium
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2019
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT04080622
- Acronym / sponsor ID
- AutoSelenium / 2018-005033-21
- Conditions
- Mucositis Oral, Stem Cell Transplant Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosUsual care |
| Selenium | Active comparator | Drug: SeleniumUsual care + selenium 300 µg/day (IV infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma.
- Signed informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumSelenium 300 µg/day (IV infusion) | Drug | Selenium |
| PlacebosNaCl 0,9% (IV infusion) | Drug | Placebo |
Primary outcome
Incidence of severe oral mucositis (grade 3-4)
Time frame: 31 months
6 secondary outcomes
Incidence of any grade oral mucositis
Time frame: 31 months
Number of days with severe oral mucositis
Time frame: 31 months
Incidence of infectious complications
Time frame: 31 months
Number of days with artifical nutrition
Time frame: 31 months
Number of days with opioids
Time frame: 31 months
Duration of hospitalization
Time frame: 31 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenium in people with Mucositis Oral and Stem Cell Transplant Complications, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe oral mucositis (grade 3-4) (time frame: 31 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.