Clinical trial · Interventional
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea
NCT01832402CI-TRIAL-00067006completedPhase 2Results 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 nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well. In this study, fentanyl will be compared to a placebo. 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 (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 Pectin Nasal Spray | Drug | — | UNRESOLVED |
| Mental Ability Tests | Behavioral | — | UNRESOLVED |
| Placebo Nasal Spray | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Walk Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fentanyl Pectin Nasal Spray
- description
- Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
- interventionNames
- Drug: Fentanyl Pectin Nasal Spray
- Other: Walk Test
- Behavioral: Questionnaires
- Behavioral: Mental Ability Tests
- type
- PLACEBO_COMPARATOR
- label
- Placebo Nasal Spray
- description
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 at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology 4. Ambulatory and able to walk with or without walking aid 5. On strong opioids with morphine equivalent daily dose of 80-500 mg, 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. Unwilling to provide informed consent 10. Patients who currently have no evidence of disease
References
Publications (1)
- DERIVEDHui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9. PMID 27401508