Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
Condition: Advanced Cancers
MeSH terms: Dyspnea
Intervention: Fentanyl Pectin Nasal Spray; Placebo Nasal Spray; Walk Test; Questionnaires; Mental Ability Tests
Intervention description: Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.; Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.; Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.; Questionnaires completed at baseline, before each walk test, and at end of final walk test.; Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Exercise-Induced Breakthrough Dyspnea; Shortness of breath; Fentanyl pectin nasal spray; Placebo nasal spray; Walk test; Questionnaires; Surveys; Mental ability tests

Summary:

      The goal of this clinical research study is to learn if fentanyl nasal spray can help to
      control shortness of breath in patients who have been treated or are being treated for
      cancer.

      Fentanyl is commonly used for treatment of cancer pain. It may help patients with their
      shortness of breath as well.

      In this study, fentanyl will be compared to a placebo. 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:

          1. Diagnosis of cancer

          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 or
             Thoracic Medical Oncology

          4. Ambulatory and able to walk with or without walking aid

          5. On strong opioids with morphine equivalent daily dose of 80-500 mg, 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. Unwilling to provide informed consent

         10. Patients who currently have no evidence of disease