Esophagitis Clinical Trial
Official title:
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer With Radiation With or Without Chemotherapy
Verified date | October 2015 |
Source | Providence Health & Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Integrative Medicine Program, Providence St. Vincent Medical Center | Portland | Oregon |
United States | The Oregon Clinic, Providence Portland Cancer Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Tolerability | Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants. | Eight (8) weeks | No |
Secondary | Esophagitis Grading | Esophagitis grade was calculated using established criteria. | Eight (8) weeks | No |
Secondary | Treatment Break Measurement | To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from =19% to =10%. | Eight (8) weeks | No |
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