Pilot Study: "Does Using a Fiber Containing Enteral Tube Feeding Formula Increase Constipation and the Use of Stool Softeners in Patients Undergoing Radiation Therapy and Have a Percutaneous Endoscopic Gastrostomy (PEG) Placed?"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Whether each patient gets constipated.
研究概览
简要总结
During radiation treatment for head and neck cancer a large percentage of patients at Mayo Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs. These patients are usually taking pain medication along with a stool softener or laxative. Currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. The investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives.
Hypothesis: Participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Cancer of: 1) lip/oral cavity 2) pharynx 3) larynx 4) nasal cavity/paranasal sinus 5) salivary gland 6) Thyroid according to AJCC cancer staging manual 6th edition 2002
- •Current radiation therapy or starting radiation therapy in the next 2 weeks
- •Patient must have a gastrostomy tube
排除标准
- •Jejunostomy tube
- •Diagnosis of Irritable Bowel Syndrome (abdominal pain and diarrhea or constipation lasting at least three months in one year)
- •Short bowel (A patient is generally considered to have short bowel syndrome when less than 100 to 150 centimeters of functioning small bowel remains)
- •Body max index (BMI) <18.5kg/m2
- •Gastroparesis (when the stomach retains food for longer than normal periods). This must be diagnosed with a gastric emptying study.
- •Use of Metoclopramide
- •Receiving 5-FU chemotherapy
结局指标
主要结局
Whether each patient gets constipated.
时间窗: Weekly for 2 weeks
次要结局
- Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.(Weekly for 2 weeks)
研究者
Lisa Epp
Home Enteral Nutrition Coordinator
Mayo Clinic