Clinical trial · Interventional
Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
A Preliminary Study of Prophylactic Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
NCT02597478CI-TRIAL-00049959completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
Conditions
Conditions (1)
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 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Sublingual Spray | Drug | — | UNRESOLVED |
| Mental Ability Tests | Behavioral | — | UNRESOLVED |
| Phone Call | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Shuttle Walk Test | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low-Dose Fentanyl Spray Group
- description
- 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.
- interventionNames
- Drug: Fentanyl Sublingual Spray
- Procedure: Shuttle Walk Test
- Behavioral: Questionnaires
- Behavioral: Mental Ability Tests
- Behavioral: Phone Call
- type
- EXPERIMENTAL
- label
- High-Dose Fentanyl Spray Group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.