Back to resultsAcidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
Primary Purpose
Oral Candidiasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acidophilus
Acidolphilus
Sponsored by
About this trial
This is an interventional treatment trial for Oral Candidiasis focused on measuring thrush
Eligibility Criteria
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.
Sites / Locations
- Summa Health System
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Acidolphilus
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00768794
Brief Title
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
Official Title
A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summa Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Candidiasis
Keywords
thrush
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acidolphilus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Acidophilus
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Acidolphilus
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Tharpe, Rn, BSN, OCN
Organizational Affiliation
Summa Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joyce Neading, RHIT, CTR
Organizational Affiliation
Summa Health System
Official's Role
Study Director
Facility Information:
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
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