Clinical Trial: Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy
Brief Summary:
The purpose of this study is to determine the effectiveness of using acidophilus to treat oral candidiasis (thrush) caused by radiation therapy to the head and neck region.
This study will conducted in two parts. In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of your mouth that are painful, you will begin taking acidophilus capsules twice each day until the last day of radiation therapy.
The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region. In the second part of the study three participants will take acidophilus capsules twice each day beginning on the first day of radiation therapy and continuing until the last day of radiation therapy.
Detailed Summary:
To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis.
To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily beginning on the first day of radiation treatments to the head and neck region prevents the development of oral thrush.
To assess subjective and objective response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements.
To assess the efficacy of Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements in preventing oral candidiasis in patients receiving radiation therapy to the head and neck region.
Sponsor: Summa Health System
Current Primary Outcome: To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis. [ Time Frame: during duration of treatment of 4 weeks. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy. [ Time Frame: during duration of treatment of 4 weeks. ]
Original Secondary Outcome: Same as current
Information By: Summa Health System
Dates:
Date Received: October 7, 2008
Date Started: July 2006
Date Completion:
Last Updated: May 30, 2013
Last Verified: May 2013
