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

Stopped early · Phase 1/Phase 2

Conditions studied: Mucositis

In brief

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.

Key facts

Study ID

NCT02575313

Run by

Providence Health & Services

People needed

10

Starts

2009-10-01

Expected to finish

2012-09-01

Last updated by the study team

2015-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Oregon Clinic, Providence Portland Cancer Center — Portland, Oregon, United States
• Integrative Medicine Program, Providence St. Vincent Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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