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

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Candidiasis
• Intervention / Treatment: Dietary supplement: Acidophilus; Dietary supplement: Acidolphilus

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Acidolphilus; 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.

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.; Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Summa Health System
• Investigators: Principal Investigator: Heather Tharpe, Rn, BSN, OCN, Summa Health System; Study Director: Joyce Neading, RHIT, CTR, Summa Health System

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: thrush
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Candidiasis, Oral
• Other Study ID Numbers: Acidophilus