Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

• Status: Completed
• Trial end date: 2021-01-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: INSYS Therapeutics Inc
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

1. Diagnosis of cancer with evidence of active disease

2. 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

3. Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic

4. Ambulatory and able to walk with or without walking aid

5. 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

6. Karnofsky performance status >/=50%

7. Age 18 or older

8. Able to complete study assessments

Exclusion Criteria:

1. Dyspnea at rest >/=7/10 at the time of enrollment

2. Supplemental oxygen requirement >6 L per minute

3. Delirium (i.e. Memorial delirium rating scale >13)

4. History of unstable angina or myocardial infarction 1 month prior to study enrollment

5. Resting heart rate >120 at the time of study enrollment

6. Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment

7. History of active opioid abuse within the past 12 months

8. History of allergy to fentanyl

9. Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*

10. Diagnosis of acute pulmonary embolism within past 2 weeks

11. Diagnosis of pulmonary hypertension

12. Unwilling to provide informed consent