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

Providence Health & Services

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Esophagitis

Treatments: Dietary Supplement: Whole Food Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02575391

10-107B

Details and patient eligibility

About

This study will evaluate whether a Whole Food Intervention reduces the frequency or severity of esophagitis in patients receiving treatment for non-small cell lung cancer.

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Whole Food Intervention Treated

Experimental group

Description:

Group of participants given the experimental WFI along with standard cancer treatment.

Treatment:

Dietary Supplement: Whole Food Intervention