Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea

NCT01856114 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2013-0043NCI-2014-01033
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. 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; Cancer with evidence of active disease; Exercise induced breakthrough dyspnea; Shortness of breath; Fentanyl Buccal Tablets; FBT; Placebo; Walk tests; Questionnaires; Surveys

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 between the baseline and second 6 minute walk test. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.

  Baseline to 30 minutes

Secondary Outcomes (2)

• Dyspnea Borg Scale

  Baseline to 30 minutes

• Walk Distance at 6 Minutes

  Baseline to 30 minutes

Study Arms (2)

Fentanyl Buccal Tablet

EXPERIMENTAL

After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Fentanyl tablet to put in between upper gum and cheek. Study physician will determine the morphine equivalent daily dose (MEDD) in real time using standardized equianalgesic ratios. Based on clinical practice and similarly to the dose used for breakthrough pain, an FBT dose equivalent to 20-50% of the MEDD used. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.

Drug: Fentanyl Buccal Tablet; Behavioral: Questionnaires

Placebo Buccal Tablet

PLACEBO COMPARATOR

After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Placebo tablet to put in between upper gum and cheek. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.

Other: Placebo Buccal Tablet; Behavioral: Questionnaires

Interventions

Fentanyl Buccal Tablet DRUG

Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.

Fentanyl Buccal Tablet

Placebo Buccal Tablet OTHER

Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.

Placebo Buccal Tablet

Questionnaires BEHAVIORAL

Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.

Also known as: Surveys

Fentanyl Buccal Tablet; Placebo Buccal Tablet

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 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, Thoracic Medical Oncology or Cardiopulmonary Center
• Ambulatory and able to walk with or without walking aid
• On strong opioids with morphine equivalent daily dose of 60-130 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
• Must speak and understand English.

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\*
• Bilirubin \>5X Upper limit of normal if documented in the last month and not lowered to \<5x normal 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
• Teva Pharmaceuticals USA: 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

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: Dr. 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: May 14, 2013
• First Posted: May 17, 2013
• Study Start: May 27, 2014
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

US (1)