TerminatedPhase 2

Sublingual Fentanyl for the Management of Breakthrough Pain

United States6 participantsStarted 2016-02-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Memorial Delirium Assessment Scale \>13/30
. History of opioid abuse
. CAGE positivity (\>=2/4)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effective Dose of Fentanyl Sublingual Spray (FSS)

Timeframe: Up to 1 months after discharge from the hospital

Trial details

NCT IDNCT02514252

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-04

Results submitted2021-04-27

View on ClinicalTrials.gov More Advanced Cancers trials