The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Measurement of Tolerability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measurement of Tolerability
时间窗: Eight (8) weeks
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
次要结局
- Treatment Break Measurement(Eight (8) weeks)
- Mucositis Grading(Eight (8) weeks)