- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02575313
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer
The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy
Study Overview
Status
Conditions
Intervention / 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:
- To determine whether patients will use a Whole Food Intervention 4-6 times daily, and
- To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% .
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97213
- The Oregon Clinic, Providence Portland Cancer Center
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Portland, Oregon, United States, 97225
- Integrative Medicine Program, Providence St. Vincent Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole Food Intervention Treated
Group of participants given the experimental WFI along with standard cancer treatment.
|
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Tolerability
Time Frame: Eight (8) weeks
|
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
|
Eight (8) weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Break Measurement
Time Frame: Eight (8) weeks
|
To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%.
|
Eight (8) weeks
|
Mucositis Grading
Time Frame: Eight (8) weeks
|
Mucositis grade was calculated using established criteria.
|
Eight (8) weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miles H Hassell, MD, Providence Health & Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-173B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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