Dexpanthenol Mouthwash to Treat Oral Mucositis
Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJuly 6, 2011
June 1, 2010
1 year
March 8, 2011
July 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
normal saline
EXPERIMENTALmouth wash of normal saline ,three times a day, 10 cc each time
Interventions
5% dexpanthenol Mouth wash , three times a day, 10 cc each time
Eligibility Criteria
You may qualify if:
- without any systemic disease
- estimated survival of at least 6 months
- without any mental disorders
- grade 1 to 3 WHO mucositis
You may not qualify if:
- development of grade 4 WHO mucositis
- Brachytherapy
- allergy to the drug
- dissatisfaction of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ShaheedBeheshti medical university
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fahimeh Anbari, resident
dental faculty of shaheed Beheshti medical university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 8, 2011
First Posted
March 21, 2011
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
July 6, 2011
Record last verified: 2010-06