Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
Condition: Advanced Cancers
MeSH terms: Dyspnea
Intervention: Fentanyl Buccal Tablet; Placebo Buccal Tablet; Questionnaires
Intervention description: Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.; Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.; Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Cancer with evidence of active disease; Exercise induced breakthrough dyspnea; Shortness of breath; Fentanyl Buccal Tablets; FBT; Placebo; Walk tests; Questionnaires; Surveys

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.
    

Eligibility 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