A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Modified Dyspnea Borg Scale (Dyspnea Intensity)
研究概览
简要总结
The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
详细描述
If you agree to take part in this study, the study staff will collect information from your medical record about your age, sex, race, and disease type, as well as how well you are able to perform the normal activities of daily living, any drugs you are taking, and any possible causes of shortness of breath.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to receive either low-dose or high-dose fentanyl spray. This is done because no one knows if one study group is better, the same, or worse than the other group.
Study Visit:
During your study visit, you will complete 2 questionnaires about any breathing problems or other symptoms you may be having. It should take about 10 minutes total to complete these questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 with evidence of active disease
- •Breakthrough dyspnea, defined as dyspnea with an average intensity level over the past 7 days of at least 3/10 on a numeric rating scale upon significant exertion or continuous dyspnea </=7/10 with worsening upon significant exertion
- •Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
- •Ambulatory and able to walk with or without walking aid
- •On strong opioids with morphine equivalent daily dose of 80-500 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- •Karnofsky performance status >/=50%
- •Age 18 or older
- •Able to complete study assessments
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 opioid abuse within the past 12 months
- •History of allergy to fentanyl
- •Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
- •Diagnosis of acute pulmonary embolism within past 2 weeks
- •Diagnosis of pulmonary hypertension
- •Unwilling to provide informed consent
研究组 & 干预措施
Low-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Fentanyl Sublingual Spray (Drug)
Low-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Shuttle Walk Test (Procedure)
Low-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Questionnaires (Behavioral)
Low-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Mental Ability Tests (Behavioral)
Low-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Phone Call (Behavioral)
High-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Fentanyl Sublingual Spray (Drug)
High-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Shuttle Walk Test (Procedure)
High-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Questionnaires (Behavioral)
High-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Mental Ability Tests (Behavioral)
High-Dose Fentanyl Spray Group
Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
干预措施: Phone Call (Behavioral)
结局指标
主要结局
Modified Dyspnea Borg Scale (Dyspnea Intensity)
时间窗: Before and after the first and second shuttle walk tests
The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
次要结局
- Fatigue Modified Borg Score(Before and after the first and second shuttle walk tests)
- Walk Distance(After the first shuttle walk test and after the second shuttle walk test)
- Walk Time(After the first shuttle walk test and after the second shuttle walk test)
- Modified Dyspnea Borg Scale (Dyspnea Unpleasantness)(Before and after the first and second shuttle walk tests)