Clinical trial · Interventional
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients
Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients
NCT04188418CI-TRIAL-00121496active not recruitingPhase 3ClinicalTrials.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)
This phase II trial studies fentanyl buccal tablet or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual tablet and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.
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 |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Citrate Buccal Tablet | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
| Physical Performance Testing | Other | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I (shuttle walk test, FBT)
- description
- Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.
- interventionNames
- Drug: Fentanyl Citrate Buccal Tablet
- Other: Physical Performance Testing
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Group II (shuttle walk test, morphine)
- description
- Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
- interventionNames
- Drug: Morphine
- Other: Physical Performance Testing
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
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. Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale 3. Outpatient at participating centers 4. Ambulatory and able to walk, with or without walking aid 5. On strong opioids with morphine equivalent daily dose (MEDD) of 60-400 mg for ≥1 wk (i.e. at least 4 out of 7 days), with stable (i.e. ±30%) regular dose over the last 3 d 6. Karnofsky performance status ≥40% 7. Age ≥18 yrs 8. Able to complete study assessments 9. Able to speak English or Spanish 10. Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month Exclusion Criteria: 1. Dyspnea at rest ≥7/10 on modified Borg scale at enrollment 2. Supplemental oxygen requirement \>6 L/min 3. Delirium (i.e. Memorial Delirium Assessment Scale ≥13) 4. History of unstable angina or myocardial infarction 1 mo prior to enrollment 5. Hemodynamic instability requiring hospitalization 6. History of substance use disorder or abnormal urinary drug screen within the past year, or at risk of opioid abuse as determined by Screener and Opioid Assessment for Patients with Pain (SOAPP14) ≥7 7. History of or known allergy to fentanyl or morphine sulfate 8. Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study 9. Severe anemia (Hb \<7 g/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 enrollment\* 11. Diagnosis of acute pulmonary embolism within past 2 wks 12. Diagnosis of pulmonary hypertension 13. Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks 14. Currently pregnant or breastfeeding 15. Unwilling to provide informed consent
References
Publications (1)
- DERIVEDHui D, Pacheco S, Nguyen L, Jennings K, de la Cruz V, Stanton P, Laureano R, Ontai A, Mahler D, Bruera E. Efficacy of fentanyl buccal tablet and morphine for exertional dyspnoea in patients with cancer: a double-blind, placebo-controlled, randomised clinical trial. Thorax. 2026 Mar 13;81(4):344-356. doi: 10.1136/thorax-2025-222970. PMID 41115797