Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo.
Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to either receive fentanyl or placebo. You will have an equal chance of being assigned to either group.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor corridor for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.
After that, you will sit down and rest (for up to 1 hour). During this time, the study drug/placebo will be prepared.
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
- Double (Participant, 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
- •Diagnosis of cancer
- •Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale
- •Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
- •Able to communicate in English or Spanish
- •Ambulatory and able to walk with or without walking aid
- •On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- •Karnofsky performance status >=50%
- •Age 18 or older
排除标准
- •Dyspnea at rest >=7/10 at the time of enrollment
- •Supplemental oxygen requirement >6 L per minute
- •Delirium (i.e. Memorial delirium rating scale >13)
- •History of unstable angina or myocardial infarction 1 month prior to study enrollment
- •Resting heart rate >120 at the time of study enrollment
- •Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
- •History of active substance abuse within the past 12 months
- •History of allergy to fentanyl
- •Unwilling to provide informed consent
研究组 & 干预措施
Fentanyl
Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Fentanyl (Drug)
Fentanyl
Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Walking Tests (Other)
Fentanyl
Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Placebo (Other)
Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Walking Tests (Other)
Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Retention Rate
时间窗: Baseline to study completion, up to 100 minutes.
Retention rate is defined as the percentage of subjects able to complete the study.
次要结局
- Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea(Baseline to 100 minutes for study participation.)
- Effect of Fentanyl on Walk Distance(Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.)