Breakthrough Dyspnea Fentanyl Study
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01515566
First received: January 13, 2012
Last updated: April 19, 2013
Last verified: April 2013
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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: | A Preliminary Study of Prophylactic Subcutaneous Fentanyl for Exercise-Induced Breakthrough Dyspnea |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea [ Time Frame: 100 minutes ] [ 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. Before and after each walk test, the study staff record heart rate, breathing rate, and the level of air breathed out using a measuring device clipped onto participant's finger.
| Enrollment: | 26 |
| Study Start Date: | April 2012 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fentanyl
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo. 2 Questionnaires completed at baseline taking about 10 minutes to complete. 1 questionnaire 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
2 Questionnaires completed at baseline taking about 10 minutes to complete. 1 questionnaire completed after study visit taking about 5 minutes to complete.
Other Name: Surveys
|
|
Active Comparator: Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo. 2 Questionnaires completed at baseline taking about 10 minutes to complete. 1 questionnaire 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
2 Questionnaires completed at baseline taking about 10 minutes to complete. 1 questionnaire completed after study visit taking about 5 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:
- 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 or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
- Able to communicate in English or Spanish
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status >=50%
- Age 18 or older
Exclusion Criteria:
- 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 substance abuse within the past 12 months
- History of allergy to fentanyl
- Unwilling to provide informed consent
Contacts and Locations
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
| 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 |
| Last Updated: | April 19, 2013 |
| 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 Neoplasms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013