Breakthrough Dyspnea Fentanyl Study in Cancer Patients
Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
August 22, 2014
CompletedAugust 22, 2014
August 1, 2014
1 year
January 13, 2012
August 7, 2014
August 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention Rate
Retention rate is defined as the percentage of subjects able to complete the study.
Baseline to study completion, up to 100 minutes.
Secondary Outcomes (2)
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.
Study Arms (2)
Fentanyl
EXPERIMENTALFentanyl 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.
Placebo
ACTIVE COMPARATORNormal 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.
Interventions
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.
6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.
Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hui D, Xu A, Frisbee-Hume S, Chisholm G, Morgado M, Reddy S, Bruera E. Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: a preliminary double-blind, randomized, controlled trial. J Pain Symptom Manage. 2014 Feb;47(2):209-17. doi: 10.1016/j.jpainsymman.2013.03.017. Epub 2013 Jul 3.
PMID: 23830530DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The small sample size means findings are susceptible to random errors and regression to the mean.
Results Point of Contact
- Title
- David Hui, MD, MSc, FRCPC / Asst. Professor, Palliative Care and Rehabilitation Medicine
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David Hui, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
January 24, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 22, 2014
Results First Posted
August 22, 2014
Record last verified: 2014-08