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

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00768794
First received: October 7, 2008
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Oral Candidiasis
 Dietary Supplement: Acidophilus
Dietary Supplement: Acidolphilus

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Summa Health System:

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. [ Time Frame: during duration of treatment of 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: July 2006
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Acidophilus
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768794

Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Heather Tharpe, Rn, BSN, OCN Summa Health System
Principal Investigator: Heather Tharpe, RN, BSN, OCN Summa Health System
  More Information

No publications provided

Responsible Party: Heather Tharpe, RN, BSN, OCN, Summa Health System
ClinicalTrials.gov Identifier: NCT00768794     History of Changes
Other Study ID Numbers: Acidophilus
Study First Received: October 7, 2008
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
thrush

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Head and Neck Neoplasms
Mycoses
 Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013