Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy

Oral Candidiasis Clinical Trial

Official title:

A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768794
• Other study ID #: Acidophilus
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: May 30, 2013
• Start date: July 2006
• Est. completion date: September 2010

Study information

• Verified date: May 2013
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck region receiving > 50 Gy to head and neck tumor with or without concomitant chemotherapy and/or cetuximab.

• Age = 18

• Karnofsky Performance Score of > 70

• History and physical examination within 8 weeks prior to registration

• Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.

• Patients with carcinoma in-situ of the breast, oral cavity, or cervix are eligible.

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

• Acute bacterial or fungal infection requiring intravenous or oral antibiotics at study entry

• Sjoren's syndrome

• Hypoadrenalism

• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.

• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

• Prior allergic reaction to Lactobacillus acidophilus.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Oral Candidiasis

Intervention

Dietary Supplement:
• Acidophilus
Use of Acidophilus 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 their mouth that are painful, subjects 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.
• Acidolphilus
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.

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		during duration of treatment of 4 weeks.	No
Secondary	To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy.		during duration of treatment of 4 weeks.	No