Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Retention Rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Questionnaires (Behavioral)
Outcomes
Primary Outcomes
Retention Rate
Time Frame: Baseline to study completion, up to 100 minutes.
Retention rate is defined as the percentage of subjects able to complete the study.
Secondary Outcomes
- 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.)