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Effects of topical vitamin E solution in mucositis

Evaluation of effects of topical solution of vitamin E in preventing oral mucositis in Allogenic Hematopoietic Stem Cell Transplantation patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180416039325N1
Enrollment
80
Registered
2018-07-25
Start date
2018-07-23
Completion date
Unknown
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral mucositis. Oral mucositis (ulcerative)

Interventions

Intervention group: Patients in the intervention group are supposed to receive vitamin E mouth wash solution, that contain 400 IU of the drug in each dose, twice daily and be evaluated daily by the

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age older than 18 years Receiving conditioning regimen with Busulfan and Cyclophosphamide

Exclusion criteria

Exclusion criteria: Showing active mucositis signs and symptoms at the time of admission Active bleeding Any contraindication to vitamin E as hypersensitivity reactions

Design outcomes

Primary

MeasureTime frame
Incidence of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale.;Severity of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale.

Secondary

MeasureTime frame
Duration of Bone Marrow Transplant ward stay. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records.;The need for narcotic analgesic. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMoluk Haji Babayi

Tehran University of Medical Sciences

m-solduzian@razi.tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026