Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea

• Status: Completed
• Trial end date: 2019-12-04
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug 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.

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.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Teva Pharmaceuticals USA
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

1. Diagnosis of cancer with evidence of active disease

2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >/=3/10 on the numeric rating scale

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

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

5. On strong opioids with morphine equivalent daily dose of 60-130 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

9. Must speak and understand English.

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. Bilirubin >5X Upper limit of normal if documented in the last month and not lowered to <5x normal prior to study enrollment*

11. Diagnosis of acute pulmonary embolism within past 2 weeks

12. Diagnosis of pulmonary hypertension

13. Unwilling to provide informed consent