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

Completed · Not applicable

Conditions studied: Oral Candidiasis

In brief

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.

Key facts

Study ID

NCT00768794

Run by

Summa Health System

People needed

5

Starts

2006-07-01

Expected to finish

2010-09-01

Last updated by the study team

2013-05-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Summa Health System — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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