Dexpanthenol Mouthwash to Treat Oral Mucositis

Oral Mucositis (Ulcerative) Due to Radiation Clinical Trial

Official title:

Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01318889
• Other study ID #: BMU1360
• Status: Recruiting
• Phase: Phase 2
• First received: March 8, 2011
• Last updated: July 5, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: Fahimeh Anbari, resident
• Phone: +98 9197263620
• Email: fahimeh.anbari[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis (Ulcerative) Due to Radiation
• Stomatitis

Intervention

Drug:
• Dexpanthenol
5% dexpanthenol Mouth wash , three times a day, 10 cc each time

Locations

Country	Name	City	State
Iran, Islamic Republic of	ShaheedBeheshti medical university	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of intensity of mucositis	measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort	first week (week one)	No