Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 56 for:    insys

Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02597478
Recruitment Status : Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
INSYS Therapeutics Inc
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Fentanyl Sublingual Spray Procedure: Shuttle Walk Test Behavioral: Questionnaires Behavioral: Mental Ability Tests Behavioral: Phone Call Phase 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
Actual Study Start Date : January 4, 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-Dose Fentanyl Spray Group
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

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.

Other Names:
  • Fentanyl SL Spray
  • FSS

Procedure: Shuttle Walk Test
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.

Behavioral: Questionnaires
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.
Other Name: Surveys

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

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

Experimental: High-Dose Fentanyl Spray Group
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

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.

Other Names:
  • Fentanyl SL Spray
  • FSS

Procedure: Shuttle Walk Test
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.

Behavioral: Questionnaires
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.
Other Name: Surveys

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

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




Primary Outcome Measures :
  1. Difference of Dyspnea Modified Borg Score with Prophylactic Fentanyl Sublingual Spray (FSS) on Exercise-Induced Dyspnea [ Time Frame: 1 day ]
    Researchers have an 80% power to detect an effect size of 0.778 in difference of the dyspnea modified Borg score change after a shuttle walk test before and after the treatment (i.e., between the first and second shuttle walk) using a two-sided paired t-test with a significance level of 0.05.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of cancer with evidence of active disease
  2. 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
  3. Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
  4. Ambulatory and able to walk with or without walking aid
  5. 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
  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. Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
  10. Diagnosis of acute pulmonary embolism within past 2 weeks
  11. Diagnosis of pulmonary hypertension
  12. Unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597478


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
INSYS Therapeutics Inc
Investigators
Layout table for investigator information
Principal Investigator: David Hui, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02597478     History of Changes
Other Study ID Numbers: 2015-0137
NCI-2015-02132 ( Registry Identifier: NCI CTRP )
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Fentanyl Sublingual Spray
Fentanyl SL Spray
FSS
Questionnaires
Surveys
Mental Abilities Test
Phone Call
Shuttle Walk Test

Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics