Mucositis
Conditions
Keywords
L-Glutamine, chemotherapy, radiotherapy, therapeutic toxicity
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.
Interventions
DIETARY_SUPPLEMENTWhole Food Intervention
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
Sponsors
Providence Health & Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Tolerability | Eight (8) weeks | Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucositis Grading | Eight (8) weeks | Mucositis grade was calculated using established criteria. |
| Treatment Break Measurement | Eight (8) weeks | To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%. |
Countries
United States
Outcome results
None listed