Clinical Trial: Study of Dentoxol® Mouthrinse for Oral Mucositis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer
Brief Summary: The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
Detailed Summary:
Sponsor: Ingalfarma SpA
Current Primary Outcome: Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale. [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
- Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ). [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
- Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ). [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
- Weight loss, as measured by the difference between weight on first and last day of radiation therapy. [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
- Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents. [ Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks) ]
Original Secondary Outcome: Same as current
Information By: Ingalfarma SpA
Dates:
Date Received: August 26, 2016
Date Started: November 2014
Date Completion: July 2017
Last Updated: September 30, 2016
Last Verified: August 2016
