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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Depomed
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01832402
First received: April 10, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Drug: Fentanyl Pectin Nasal Spray
Drug: Placebo Nasal Spray
Other: Walk Test
Behavioral: Questionnaires
Behavioral: Mental Ability Tests
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effect of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    The main goal of this study is to determine the effect size for both fentanyl pectin nasal spray (FPNS) and placebo arm. Comparisons within arms performed using paired t-tests or signed rank tests. Summary descriptive statistics will be provided for demographics, outcomes, and other collected variables and will include proportions, medians, means, 95% confidence intervals, and other simple statistics as appropriate for the measure.


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl Pectin Nasal Spray
Fentanyl 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.
Drug: Fentanyl Pectin Nasal Spray
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.
Other: 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.
Behavioral: Questionnaires
Questionnaires completed at baseline, before each walk test, and at end of final walk test.
Other Name: Surveys
Behavioral: Mental Ability Tests
Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
Placebo Comparator: Placebo Nasal Spray
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 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.
Drug: Placebo Nasal Spray
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.
Other: 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.
Behavioral: Questionnaires
Questionnaires completed at baseline, before each walk test, and at end of final walk test.
Other Name: Surveys
Behavioral: Mental Ability Tests
Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832402

Contacts
Contact: David Hui, MD 713-792-6085

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Depomed
Investigators
Principal Investigator: David Hui, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01832402     History of Changes
Other Study ID Numbers: 2012-1169, NCI-2013-00961
Study First Received: April 10, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Exercise-Induced Breakthrough Dyspnea
Shortness of breath
Fentanyl pectin nasal spray
Placebo nasal spray
Walk test
Questionnaires
Surveys
Mental ability tests

Additional relevant MeSH terms:
Dyspnea
Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fentanyl
Pectin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antidiarrheals
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 19, 2014