search
Back to results

Dexpanthenol Mouthwash to Treat Oral Mucositis

Primary Purpose

Oral Mucositis (Ulcerative) Due to Radiation

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dexpanthenol
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis (Ulcerative) Due to Radiation focused on measuring Dexpanthenol, Radiotherapy, chemotherapy, Mucositis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. without any systemic disease
  2. estimated survival of at least 6 months
  3. without any mental disorders
  4. grade 1 to 3 WHO mucositis

Exclusion Criteria:

  1. development of grade 4 WHO mucositis
  2. Brachytherapy
  3. allergy to the drug
  4. dissatisfaction of the patient

Sites / Locations

  • ShaheedBeheshti medical universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

normal saline

Arm Description

mouth wash of normal saline ,three times a day, 10 cc each time

Outcomes

Primary Outcome Measures

reduction of intensity of mucositis
measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort

Secondary Outcome Measures

Full Information

First Posted
March 8, 2011
Last Updated
July 5, 2011
Sponsor
Shahid Beheshti University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01318889
Brief Title
Dexpanthenol Mouthwash to Treat Oral Mucositis
Official Title
Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.
Detailed Description
Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis (Ulcerative) Due to Radiation
Keywords
Dexpanthenol, Radiotherapy, chemotherapy, Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal saline
Arm Type
Experimental
Arm Description
mouth wash of normal saline ,three times a day, 10 cc each time
Intervention Type
Drug
Intervention Name(s)
Dexpanthenol
Other Intervention Name(s)
Physiologic serum
Intervention Description
5% dexpanthenol Mouth wash , three times a day, 10 cc each time
Primary Outcome Measure Information:
Title
reduction of intensity of mucositis
Description
measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort
Time Frame
first week (week one)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: without any systemic disease estimated survival of at least 6 months without any mental disorders grade 1 to 3 WHO mucositis Exclusion Criteria: development of grade 4 WHO mucositis Brachytherapy allergy to the drug dissatisfaction of the patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahimeh Anbari, resident
Phone
+98 9197263620
Email
fahimeh.anbari@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jamileh beigom Taheri, professor
Email
jm_taheri2006@yhoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahimeh Anbari, resident
Organizational Affiliation
dental faculty of shaheed Beheshti medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShaheedBeheshti medical university
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahimeh Anbari, postgraduate student
First Name & Middle Initial & Last Name & Degree
Jamileh beigom Taheri, professor
First Name & Middle Initial & Last Name & Degree
Fahimeh Anbari, Resident

12. IPD Sharing Statement

Learn more about this trial

Dexpanthenol Mouthwash to Treat Oral Mucositis

We'll reach out to this number within 24 hrs