Sublingual Fentanyl for the Management of Breakthrough Pain
Condition: Advanced Cancers
MeSH terms: Breakthrough Pain
Intervention: Fentanyl Sublingual Spray (FSS); Questionnaires; Mental Ability Tests; Study Diary
Intervention description: Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.
Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.
Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).
Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks.; Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.; Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.; Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Metastatic; Recurrent cancer; Incurable cancer; Fentanyl sublingual spray; FSS; Questionnaires; Surveys; Mental ability tests; Phone calls; Study diary; Pain control

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.
    

Eligibility 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