Clinical trial · Interventional
Breakthrough Dyspnea Fentanyl Study in Cancer Patients
Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Dyspnea | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Walking Tests | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fentanyl
- description
- 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.
- interventionNames
- Drug: Fentanyl
- Other: Walking Tests
- Behavioral: Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Placebo
- Other: Walking Tests
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHui D, Xu A, Frisbee-Hume S, Chisholm G, Morgado M, Reddy S, Bruera E. Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: a preliminary double-blind, randomized, controlled trial. J Pain Symptom Manage. 2014 Feb;47(2):209-17. doi: 10.1016/j.jpainsymman.2013.03.017. Epub 2013 Jul 3. PMID 23830530