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

Sponsored by:	Summa Health System
Information provided by:	Summa Health System
ClinicalTrials.gov Identifier:	NCT00768794

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:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Dietary Supplements Diets Head and Neck Cancer Radiation Therapy Yeast Infections

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
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acidolphilus: Active Comparator 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.

Arms

Assigned Interventions

Acidolphilus: Active Comparator

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.

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

Contacts

Contact: Heather Tharpe, RN, BSN, OCN	330-375-4578	tharpeh@summa-health.org
Contact: Joyce Neading, RHIT, CTR	330-375-4221	neadingja@summa-health.org

Locations

United States, Ohio
Summa Health System	Recruiting
Akron, Ohio, United States, 44304
Contact: Heather Tharpe, RN, BSN, OCN 330-375-4578 tharpeh@summa-health.org
Contact: Joyce Neading, RHIT, CTR 330-375-4221 neadingja@summa-health.org
Principal Investigator: Heather Tharpe, RN, BSN, OCN
Sub-Investigator: Joyce Neading, RHIT, CTR

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

Keywords provided by Summa Health System:

thrush

Study placed in the following topic categories:

Mouth Diseases
Mycoses
Candidiasis, Oral
Candidiasis

Head and Neck Neoplasms
Acidophilus
Stomatognathic Diseases

Additional relevant MeSH terms:

Mouth Diseases
Mycoses
Neoplasms
Candidiasis, Oral

Neoplasms by Site
Candidiasis
Head and Neck Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 06, 2009