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

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.