The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer

The proposal is a one center, open label, randomized pilot study to evaluate the safety,
tolerability and compliance of a Whole Food Intervention with Standard of Care for patients
with non-small cell lung cancer. The primary objectives are:

1. To determine whether patients will use a Whole Food Intervention 4-6 times daily, and

2. To determine whether the Whole Food Intervention will reduce the incidence of grade 2
or greater esophagitis from 75% historically seen to 25% .

3. To determine whether Whole Food Intervention will reduce the incidence of treatment
breaks from >19% to < 10% (see section 9 for comments)

This Whole Food Intervention will be taken by mouth before the start of radiation therapy,
with or without chemotherapy and for the entire treatment therapy.

Esophagitis-related pain and reduction of oral intake will be quantified by using validated
assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function
and the use of conventional medication for radiation-induced esophagitis will be recorded.
Chart review and patient questionnaires will be used to establish whether a treatment break
or dose reduction for radiation of chemotherapy was required due to radiation
esophagitis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be
extracted from the patients' medical oncologist's or radiation oncologist's records. The
patient will continue to use standard esophagitis therapies if desired as prescribed by the
treating oncology physician.

The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3
portioning cups, equal to approximately 12 ounces, taken daily before starting radiation
therapy. A questionnaire will be used to record symptoms and doses taken. The patient will
continue to use standard esophagitis therapies as prescribed by the treating oncology
physician.

Inclusion Criteria:

- Histopathologically confirmed diagnosis of thoracic carcinoma

- Scheduled to undergo continuous daily course of radiation therapy with or without
chemotherapy

- No other serious concurrent medical illness as determined by the Principle
Investigator

- Absolute neutrophil count ≥ 500/mm3

- Platelet count ≥ 50,000/mm3

- No history of insulin-dependent diabetes mellitus

- No prior hypersensitivity reaction to compound components

Exclusion Criteria:

- Dislike of the available forms of the WFI

- Allergy or food intolerance relevant to the ingredients

- Lack of access to refrigerated storage for the WFI

- Inability or unwillingness to participate twice a week

- Inability to swallow

- Undergoing treatment for HIV with HIV medications

- Ongoing alcohol and/or drug abuse