Sublingual Fentanyl for the Management of Breakthrough Pain

• Status: Terminated
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: INSYS Therapeutics Inc
• Treatments: Analgesics; Fentanyl

Criteria

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