Sublingual Fentanyl for the Management of Breakthrough Pain

Stopped early · Phase 2

Conditions studied: Advanced Cancers

In brief

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.

Key facts

Study ID

NCT02514252

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2016-02-02

Expected to finish

2019-11-04

Last updated by the study team

2021-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
• Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
• On strong opioid intravenous continuous infusion MEDD >=70 mg/day at the time of enrollment.
• Inpatient at MD Anderson seen by palliative care team.
• Background cancer pain that is <=3/10 in the last 24 hours.
• Breakthrough cancer pain that is >=4/10 in the last 24 hours.
• Stable pain control defined as rescue doses <=6 in last 24 hours.
• Age >=18
• Ability to communicate in English

You may not qualify if…

• Memorial Delirium Assessment Scale >13/30
• History of opioid abuse
• CAGE positivity (>=2/4)
• Allergy to fentanyl
• Grade 2 or higher oral mucositis
• Unable/unwilling to sign consent

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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