MucositisPhase 1/2NCT01432873
Oral Selenium Therapy for the Prevention of Mucositis
A Phase 1/2 study testing Oral selenium in people with Mucositis and Hematopoietic Stem Cell Transplantation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mucositis, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Oral selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteIran
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
- Adequate renal and hepatic function
Who cannot join
- Taking selenium supplement before admission
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hematology-Oncology & SCT Research Center
Tehran
Molouk Hadjibabaie, Pharma D., +989122838464
Molouk Hadjibabaie, Pharma D
About this study
Official title: A Randomized Double Blinded Placebo Controlled Oral Selenium Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Hematopoietic Stem Cell Transplantation
Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) \& acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).
Read the detailed description
Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study.
Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21.
Response assessment will include:
- Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21.
- Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14.
- Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation
- Being tested
- Oral selenium, Oral placebo
- Keywords
- BMT, HSCT
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral seleniumDrug
Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
Oral placeboDrug
Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Oral selenium therapy arm Receives: Drug: Oral selenium |
| Placebo | Placebo comparator | Oral placebo Receives: Drug: Oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The grade of oral mucositis after bone marrow transplantation
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (2)
Evaluation of selenium concentration and glutathione peroxidase level in serum
Measured: up to 3 weeks
Total days of mucositis after BMT
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Molouk Hadjibabaie, Pharma D, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432873
- Sponsor's protocol ID
- HORCSCT-9001
- Status last verified
- May 2012
- First submitted
- 25 Jul 2011
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jahangard-Rafsanjani Z, Gholami K, Hadjibabaie M, Shamshiri AR, Alimoghadam K, Sarayani A, Mojtahedzadeh M, Ostadali-Dehaghi M, Ghavamzadeh A. The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial. Bone Marrow Transplant. 2013 Jun;48(6):832-6. doi: 10.1038/bmt.2012.250. Epub 2013 Jan 7.
PubMed 23292233
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Placebo Controlled Oral Selenium Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01432873
- Acronym / sponsor ID
- HORCSCT-9001
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation
- Keywords
- BMT, HSCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Sep 2011 (estimated)
- 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.
Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) \& acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).
Detailed description
Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study.
Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21.
Response assessment will include:
- Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21.
- Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14.
- Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Oral seleniumOral selenium therapy arm |
| Placebo | Placebo comparator | Drug: Oral placeboOral placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
- Adequate renal and hepatic function
Key exclusion criteria (1 listed)
- Taking selenium supplement before admission
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 |
|---|---|---|
| Oral seleniumDrug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge | Drug | Experimental |
| Oral placeboDrug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge | Drug | Placebo |
Primary outcome
The grade of oral mucositis after bone marrow transplantation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation
2 secondary outcomes
Evaluation of selenium concentration and glutathione peroxidase level in serum
Time frame: up to 3 weeks
Total days of mucositis after BMT
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- Derived from this study: PubMed 23292233Jahangard-Rafsanjani Z, Gholami K, Hadjibabaie M, Shamshiri AR, Alimoghadam K, Sarayani A, Mojtahedzadeh M, Ostadali-Dehaghi M, Ghavamzadeh A. The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial. Bone Marrow Transplant. 2013 Jun;48(6):832-6. doi: 10.1038/bmt.2012.250. Epub 2013 Jan 7.
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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.
Molouk Hadjibabaie, Pharma D study chair
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral selenium in people with Mucositis and Hematopoietic Stem Cell Transplantation, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2012. 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 Iran. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The grade of oral mucositis after bone marrow transplantation (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01432873, which also lists 1 linked publication.
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 4 Jun 2012.