Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

NCT02597478 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2015-0137NCI-2015-02132
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.

Conditions

Advanced Cancers

Keywords

Advanced Cancers; Fentanyl Sublingual Spray; Fentanyl SL Spray; FSS; Questionnaires; Surveys; Mental Abilities Test; Phone Call; Shuttle Walk Test

Outcome Measures

Primary Outcomes (1)

• Modified Dyspnea Borg Scale (Dyspnea Intensity)

  The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.

  Before and after the first and second shuttle walk tests

Secondary Outcomes (4)

• Modified Dyspnea Borg Scale (Dyspnea Unpleasantness)

  Before and after the first and second shuttle walk tests

• Walk Distance

  After the first shuttle walk test and after the second shuttle walk test

• Walk Time

  After the first shuttle walk test and after the second shuttle walk test

• Fatigue Modified Borg Score

  Before and after the first and second shuttle walk tests

Study Arms (2)

Low-Dose Fentanyl Spray Group

EXPERIMENTAL

Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving low-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. Low-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.

Drug: Fentanyl Sublingual Spray; Procedure: Shuttle Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests; Behavioral: Phone Call

High-Dose Fentanyl Spray Group

EXPERIMENTAL

Questionnaires completed at baseline and at end of study visit. Participant performs Shuttle Walk Test before and after receiving high-dose Fentanyl sublingual spray. Four mental ability tests completed after each walk test. High-dose Fentanyl sprayed into mouth and under tongue one hour after first Shuttle Walk Test.

Drug: Fentanyl Sublingual Spray; Procedure: Shuttle Walk Test; Behavioral: Questionnaires; Behavioral: Mental Ability Tests; Behavioral: Phone Call

Interventions

Fentanyl Sublingual Spray DRUG

Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test. High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.

Also known as: Fentanyl SL Spray, FSS

High-Dose Fentanyl Spray Group; Low-Dose Fentanyl Spray Group

Shuttle Walk Test PROCEDURE

Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.

High-Dose Fentanyl Spray Group; Low-Dose Fentanyl Spray Group

Questionnaires BEHAVIORAL

Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.

Also known as: Surveys

High-Dose Fentanyl Spray Group; Low-Dose Fentanyl Spray Group

Mental Ability Tests BEHAVIORAL

After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.

High-Dose Fentanyl Spray Group; Low-Dose Fentanyl Spray Group

Phone Call BEHAVIORAL

Thirty days study visit participant called by study staff. This call should last about 10 minutes.

High-Dose Fentanyl Spray Group; Low-Dose Fentanyl Spray Group

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 with evidence of active disease
• Breakthrough dyspnea, defined as dyspnea with an average intensity level over the past 7 days of at least 3/10 on a numeric rating scale upon significant exertion or continuous dyspnea \</=7/10 with worsening upon significant exertion
• Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
• Ambulatory and able to walk with or without walking aid
• On strong opioids with morphine equivalent daily dose of 80-500 mg for at least one week, 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
• Severe anemia (Hb \<7g/L) if documented in the last month and not corrected prior to study enrollment\*
• Diagnosis of acute pulmonary embolism within past 2 weeks
• Diagnosis of pulmonary hypertension
• Unwilling to provide informed consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• INSYS Therapeutics Inc: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Surveys and Questionnaires

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: January 4, 2016
• Primary Completion: September 27, 2018
• Study Completion: January 27, 2021
• Last Updated: February 9, 2021
• Results First Posted: December 8, 2020

Record last verified: 2021-01

Locations

US (1)