NCT04239261终止2 期
A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Development of Oral Mucositis during ChemoRadiation Treatment
研究概览
简要总结
The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve nutritional status and lessen the symptoms associated with chemo-radiation therapy which may result in quality of life (QOL) improvements during the prescribed treatment for cancer therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Informed consent obtained and signed
- •Male or female at least 18 years of age
- •Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy
- •Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria
- •Not experiencing diarrhea during the 5 days preceding enrollment, as defined by having less than two unformed bowel movements per day or loose (mushy) or watery stools in the 5 days preceding enrollment.
- •Not currently taking anti-diarrheal medications (prescription or over the counter).
- •Agrees and is able to take the investigational products or placebo starting from the day of enrollment (approximately 7-14 days prior to beginning chemo-radiation therapy) through 6-7 weeks of chemo-radiation therapy (for a total of 8-9 weeks).
排除标准
- •History of uncontrolled diarrhea during screening.
- •History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.
- •History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.
- •History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.
- •Known allergy or intolerance to beef or soy or any ingredient used in the product
- •History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo.
- •Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy).
- •Unable to comply with the protocol requirements.
- •Any condition that in the opinion of the Investigator might interfere with the study objective.
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
Development of Oral Mucositis during ChemoRadiation Treatment
时间窗: Baseline and Up to approximately 90 days after randomization
CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable
次要结局
- Development of Dysphagia during ChemoRadiation Treatment(Baseline and Up to approximately 90 days after randomization)
- Change in Bowel Movements(Baseline and Up to approximately 90 days after randomization)
研究者
Richard Deming, MD
Principal Investigator
MercyOne Des Moines Medical Center
研究点 (2)
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