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

NCT01832402 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-1169NCI-2013-00961
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancers

Keywords

Advanced Cancers; Exercise-Induced Breakthrough Dyspnea; Shortness of breath; Fentanyl pectin nasal spray; Placebo nasal spray; Walk test; Questionnaires; Surveys; Mental ability tests

Outcome Measures

Primary Outcomes (1)

• Dyspnea Numeric Rating Scale

  Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.

  1.5 to 2 hours on a Single visit

Secondary Outcomes (2)

• Dyspnea Borg Scale

  1.5 to 2 hours on a Single visit

• Walk Distance at 6 Minutes

  1.5 to 2 hours on a Single visit

Study Arms (2)

Fentanyl Pectin Nasal Spray

EXPERIMENTAL

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; Other: Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests

Placebo Nasal Spray

PLACEBO COMPARATOR

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; Other: Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests

Interventions

Fentanyl Pectin Nasal Spray DRUG

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.

Fentanyl Pectin Nasal Spray

Placebo Nasal Spray DRUG

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.

Placebo Nasal Spray

Walk Test OTHER

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.

Fentanyl Pectin Nasal Spray; Placebo Nasal Spray

Questionnaires BEHAVIORAL

Questionnaires completed at baseline, before each walk test, and at end of final walk test.

Also known as: Surveys

Fentanyl Pectin Nasal Spray; Placebo Nasal Spray

Mental Ability Tests BEHAVIORAL

Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Fentanyl Pectin Nasal Spray; Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cancer
• Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \>=3/10 on the numeric rating scale
• Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
• Ambulatory and able to walk with or without walking aid
• On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
• Karnofsky performance status \>=50%
• Age 18 or older
• Able to complete study assessments

You may not qualify if:

• Dyspnea at rest \>=7/10 at the time of enrollment
• Supplemental oxygen requirement \>6 L per minute
• Delirium (i.e. Memorial delirium rating scale \>13)
• History of unstable angina or myocardial infarction 1 month prior to study enrollment
• Resting heart rate \>120 at the time of study enrollment
• Systolic pressure \>180 mmHg or diastolic pressure \>100 mmHg at the time of study enrollment
• History of active opioid abuse within the past 12 months
• History of allergy to fentanyl
• Unwilling to provide informed consent
• Patients who currently have no evidence of disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Depomed: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9.

  PMID: 27401508 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Dyspnea

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: David Hui, MD/ Associate Professor, Palliative Care Medicine
• Organization: UT MD Anderson Cancer Center

dhui@mdanderson.org

713-792-6258

Study Officials

• David Hui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 16, 2013
• Study Start: June 11, 2013
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: June 8, 2023
• Results First Posted: September 4, 2020

Record last verified: 2023-06

Locations

US (1)