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


N/A
18 Years
80 Years
Not Enrolling
Both
Oral Candidiasis

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

during duration of treatment of 4 weeks.

Safety Issue:

No

Principal Investigator

Heather Tharpe, Rn, BSN, OCN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Summa Health System

Authority:

United States: Institutional Review Board

Study ID:

Acidophilus

NCT ID:

NCT00768794

Start Date:

July 2006

Completion Date:

September 2010

Related Keywords:

  • Oral Candidiasis
  • thrush
  • Candidiasis
  • Candidiasis, Oral
  • Head and Neck Neoplasms

Name

Location

Summa Health SystemAkron, Ohio  44312