MucositisPhase 2/3NCT01015183
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
A Phase 2/3 study testing Zinc Sulfate in people with Mucositis and Bone Marrow Transplantation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mucositis, Bone Marrow Transplantation
- What is being tested?
- Zinc Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient undergoing bone marrow transplantation
- Signed informed consent
Who cannot join
- Unable take drug (or placebo) orally
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114
About this study
Official title: Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.
- Conditions
- Mucositis, Bone Marrow Transplantation
- Being tested
- Zinc Sulfate, Placebo
- Keywords
- Mucositis, Bone Marrow Transplantation, 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.
Zinc SulfateDrug
Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy
PlaceboDrug
Placebo: as the same of intervention group
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received Zinc Sulfate Receives: Drug: Zinc Sulfate |
| Control | Placebo comparator | Control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
Measured: 1 year
Secondary outcomes (2)
Evaluation of Zinc Sulfate concentration
Measured: 1 year
Evaluation of Zinc Sulfate advance effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Molouk Hadjibabaie, PhD, Principal investigator, Hematology-Oncology and SCT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015183
- Sponsor's protocol ID
- HORCSCT-0904
- Status last verified
- Jul 2011
- First submitted
- 17 Nov 2009
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
- ClinicalTrials.gov ID
- NCT01015183
- Acronym / sponsor ID
- HORCSCT-0904
- Conditions
- Mucositis, Bone Marrow Transplantation
- Keywords
- Mucositis, Bone Marrow Transplantation, BMT, HSCT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Nov 2009 (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.
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Zinc SulfateReceived Zinc Sulfate |
| Control | Placebo comparator | Drug: PlaceboControl group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing bone marrow transplantation
- Signed informed consent
Key exclusion criteria (1 listed)
- Unable take drug (or placebo) orally
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 |
|---|---|---|
| Zinc SulfateZinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy | Drug | Intervention |
| PlaceboPlacebo: as the same of intervention group | Drug | Control |
Primary outcome
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
Time frame: 1 year
2 secondary outcomes
Evaluation of Zinc Sulfate concentration
Time frame: 1 year
Evaluation of Zinc Sulfate advance effects
Time frame: 1 year
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 26 Jul 2011.
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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, PhD principal investigator
Hematology-Oncology and SCT Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zinc Sulfate in people with Mucositis and Bone Marrow 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: finished, as of the sponsor's last update on 26 Jul 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation (time frame: 1 year). 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 26 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.