Sublingual Fentanyl for the Management of Breakthrough Pain
Advanced Cancers
About this trial
This is an interventional treatment trial for Advanced Cancers focused on measuring Advanced Cancers, Metastatic, Recurrent cancer, Incurable cancer, Fentanyl sublingual spray, FSS, Questionnaires, Surveys, Mental ability tests, Phone calls, Study diary, Pain control
Eligibility Criteria
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
- Ability to communicate in English
Exclusion Criteria:
- 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
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Fentanyl Sublingual Spray (FSS)
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.