The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer

NCT ID: NCT02575313

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-09-30

Brief Summary

This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.

Detailed 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 head & neck 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 mucositis 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.

Mucositis-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 mucositis 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 mucositis-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 mucositis 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 mucositis therapies as prescribed by the treating oncology physician.

Conditions

Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole Food Intervention Treated

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

Group Type: EXPERIMENTAL

Whole Food Intervention

Intervention Type: DIETARY_SUPPLEMENT

A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.

Interventions

Whole Food Intervention

A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Histopathologically confirmed diagnosis of head & neck 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miles H Hassell, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

The Oregon Clinic, Providence Portland Cancer Center

Portland, Oregon, United States

Integrative Medicine Program, Providence St. Vincent Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

07-173B

Identifier Type: -

Identifier Source: org_study_id