Clinical trial · Interventional
Sublingual Fentanyl for the Management of Breakthrough Pain
A Preliminary Study of Sublingual Fentanyl for the Management of Breakthrough Pain Analgesia in Patients With Advanced Cancer
NCT02514252CI-TRIAL-00051867terminatedPhase 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 an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Sublingual Spray (FSS) | Drug | — | UNRESOLVED |
| Mental Ability Tests | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Study Diary | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fentanyl Sublingual Spray (FSS)
- description
- Hospitalized participants asked to complete a number of surveys at baseline. Participants then receive one single dose of intravenous opioid rescue for their first episode of breakthrough pain, and then receive up to 4 doses of FSS for subsequent episodes of breakthrough pain. Initial FSS starting dose is proportional to the patient's morphine equivalent daily dose (MEDD). Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose. At the time of discharge, if FSS was helpful in controlling participant's pain, they are then able to continue with FSS use for 1 month. Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.
- interventionNames
- Drug: Fentanyl Sublingual Spray (FSS)
- Behavioral: Questionnaires
- Behavioral: Mental Ability Tests
- Behavioral: Study Diary
Primary outcomes (1)
- measure
- Effective Dose of Fentanyl Sublingual Spray (FSS)
- timeFrame
- Up to 1 months after discharge from the hospital
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer). 2. Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week. 3. On strong opioid intravenous continuous infusion MEDD \>=70 mg/day at the time of enrollment. 4. Inpatient at MD Anderson seen by palliative care team. 5. Background cancer pain that is \<=3/10 in the last 24 hours. 6. Breakthrough cancer pain that is \>=4/10 in the last 24 hours. 7. Stable pain control defined as rescue doses \<=6 in last 24 hours. 8. Age \>=18 9. Ability to communicate in English Exclusion Criteria: 1. Memorial Delirium Assessment Scale \>13/30 2. History of opioid abuse 3. CAGE positivity (\>=2/4) 4. Allergy to fentanyl 5. Grade 2 or higher oral mucositis 6. Unable/unwilling to sign consent
References
Publications (0)
Data not yet available
No reference posted for this study.