Prevention Chemotherapy Induced Mucositis by Zinc Sulfate | NCT01015183

Studies
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

NCT01015183

Sponsor

Tehran University of Medical Sciences

Status

Completed

Last Update Posted

Jul 26, 2011Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Mucositis
Bone Marrow Transplantation

Interventions

Zinc Sulfate
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Received Zinc Sulfate	Drug: Zinc Sulfate
Control	Placebo Comparator	Control group	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zinc Sulfate	Drug	Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation		1 year

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of Zinc Sulfate concentration		1 year
Evaluation of Zinc Sulfate advance effects		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing bone marrow transplantation
Signed informed consent

Exclusion Criteria:

Unable take drug (or placebo) orally

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Molouk Hadjibabaie, PhD	Hematology-Oncology and SCT Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology-Oncology & SCT Research Center		Tehran	Tehran Province	14114	Iran

Condition Browse Module

MeSH Terms

ID	Term
D052016	Mucositis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019287	Zinc Sulfate

Ancestor Terms

ID	Term
D013431	Sulfates
D013464	Sulfuric Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided