Status:
COMPLETED
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
Lead Sponsor:
Summa Health System
Conditions:
Oral Candidiasis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00768794
Start Date
July 1 2006
End Date
September 1 2010
Last Update
May 31 2013
Active Locations (1)
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1
Summa Health System
Akron, Ohio, United States, 44304