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Advanced Cancers | Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea

Advanced Cancers research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Advanced Cancers

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fentanyl Pectin Nasal SprayFentanyl 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.

Drug:Placebo Nasal SprayPlacebo 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.

Other:Walk TestWalk 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.

Behavioral:QuestionnairesQuestionnaires completed at baseline, before each walk test, and at end of final walk test.

Behavioral:Mental Ability TestsFour mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fentanyl Pectin Nasal SprayFentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS 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 FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS 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.

Placebo Nasal SprayPlacebo 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 placebo nasal spray. Participant will rest for 30 minutes after walk test. 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. 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.

Study Status

Active, not recruiting

Start Date: June 2013

Completed Date: June 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Effect of Prophylactic Fentanyl Pectin Nasal Spray (FPNS)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: David Hui, MD

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: Depomed

More information:https://clinicaltrials.gov/show/NCT01832402

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