Breakthrough Dyspnea Fentanyl Study in Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01515566
First received: January 13, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it 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. It is believed to help patients with their shortness of breath as well.

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
Dyspnea
Drug: Fentanyl
Other: Placebo
Other: Walking Tests
Behavioral: Questionnaires
Phase 1
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: Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Retention Rate [ Time Frame: Baseline to study completion, up to 100 minutes. ] [ Designated as safety issue: No ]
    Retention rate is defined as the percentage of subjects able to complete the study.


Secondary Outcome Measures:
  • Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea [ Time Frame: Baseline to 100 minutes for study participation. ] [ Designated as safety issue: No ]
    Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") and every 5 minutes during the rest period.

  • Effect of Fentanyl on Walk Distance [ Time Frame: Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation. ] [ Designated as safety issue: No ]
    Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.


Enrollment: 26
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl
Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
Drug: Fentanyl
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.
Other Name: Sublimaze
Other: Walking Tests
6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.
Behavioral: Questionnaires
Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.
Other Name: Surveys
Active Comparator: Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.
Other: Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test.
Other: Walking Tests
6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.
Behavioral: Questionnaires
Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.
Other Name: Surveys

  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 or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
  4. Able to communicate in English or Spanish
  5. Ambulatory and able to walk with or without walking aid
  6. On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
  7. Karnofsky performance status >=50%
  8. Age 18 or older

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 substance abuse within the past 12 months
  8. History of allergy to fentanyl
  9. Unwilling to provide informed consent
  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: NCT01515566

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

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01515566     History of Changes
Other Study ID Numbers: 2011-1007
Study First Received: January 13, 2012
Results First Received: August 7, 2014
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Dyspnea
Exercise-induced breakthrough dyspnea
Shortness of breath
Fentanyl
Sublimaze
Placebo
Normal saline
NS
Questionnaires
Surveys
Walk test

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

ClinicalTrials.gov processed this record on October 20, 2014