Phase 2 N=20 Randomized Double-blind Supportive Care

Breakthrough Dyspnea Fentanyl Study in Cancer Patients

Advanced Cancers · Dyspnea

Bottom Line

View on ClinicalTrials.gov: NCT01515566 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Retention Rate — 100; 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fentanyl (Drug); Placebo (Other); Walking Tests (Other); Questionnaires (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention Rate	100; 100	—
SECONDARY Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea	2; 3; 6; 7; 1; 2	—
SECONDARY Effect of Fentanyl on Walk Distance	397.7; 399; 434.9; 417.9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01515566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.