Clinical trial · Interventional
Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea
NCT01856114CI-TRIAL-00047185completedPhase 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 can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug 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. 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Buccal Tablet | Drug | — | UNRESOLVED |
| Placebo Buccal Tablet | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fentanyl Buccal Tablet
- description
- After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Fentanyl tablet to put in between upper gum and cheek. Study physician will determine the morphine equivalent daily dose (MEDD) in real time using standardized equianalgesic ratios. Based on clinical practice and similarly to the dose used for breakthrough pain, an FBT dose equivalent to 20-50% of the MEDD used. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
- interventionNames
- Drug: Fentanyl Buccal Tablet
- Behavioral: Questionnaires
- type
- PLACEBO_COMPARATOR
- label
- Placebo Buccal Tablet
- description
- After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Placebo tablet to put in between upper gum and cheek. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
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 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, Thoracic Medical Oncology or Cardiopulmonary Center 4. Ambulatory and able to walk with or without walking aid 5. On strong opioids with morphine equivalent daily dose of 60-130 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 9. Must speak and understand English. 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. Bilirubin \>5X Upper limit of normal if documented in the last month and not lowered to \<5x normal prior to study enrollment\* 11. Diagnosis of acute pulmonary embolism within past 2 weeks 12. Diagnosis of pulmonary hypertension 13. Unwilling to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.