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Dexpanthenol Mouthwash to Treat Oral Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318889
Recruitment Status : Unknown
Verified June 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 21, 2011
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis (Ulcerative) Due to Radiation Drug: Dexpanthenol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: normal saline
mouth wash of normal saline ,three times a day, 10 cc each time
Drug: Dexpanthenol
5% dexpanthenol Mouth wash , three times a day, 10 cc each time
Other Name: Physiologic serum




Primary Outcome Measures :
  1. reduction of intensity of mucositis [ Time Frame: first week (week one) ]
    measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318889


Contacts
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Contact: Fahimeh Anbari, resident +98 9197263620 fahimeh.anbari@gmail.com
Contact: Jamileh beigom Taheri, professor jm_taheri2006@yhoo.com

Locations
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Iran, Islamic Republic of
ShaheedBeheshti medical university Recruiting
Tehran, Iran, Islamic Republic of
Contact: Fahimeh Anbari, postgraduate student         
Sub-Investigator: Jamileh beigom Taheri, professor         
Principal Investigator: Fahimeh Anbari, Resident         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Fahimeh Anbari, resident dental faculty of shaheed Beheshti medical university
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Responsible Party: Dr Anbari, Dental Faculty of shaheed Beheshti medical University
ClinicalTrials.gov Identifier: NCT01318889    
Other Study ID Numbers: BMU1360
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: June 2010
Keywords provided by Shahid Beheshti University of Medical Sciences:
Dexpanthenol
Radiotherapy
chemotherapy
Mucositis
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases