Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (NCT04188418) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients
United States150 participantsStarted 2020-10-23
Plain-language summary
This phase II trial studies fentanyl buccal tablet or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual tablet and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.
Who can participate
Age range18 Years
SexALL
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
✓. Diagnosis of cancer with evidence of active disease
✓. Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale
✓. Outpatient at participating centers
✓. Ambulatory and able to walk, with or without walking aid
✓. On strong opioids with morphine equivalent daily dose (MEDD) of 60-400 mg for ≥1 wk (i.e. at least 4 out of 7 days), with stable (i.e. ±30%) regular dose over the last 3 d
✓. Karnofsky performance status ≥40%
✓. Age ≥18 yrs
✓. Able to complete study assessments
Exclusion criteria
✕. Dyspnea at rest ≥7/10 on modified Borg scale at enrollment
✕. Supplemental oxygen requirement \>6 L/min
✕. Delirium (i.e. Memorial Delirium Assessment Scale ≥13)
✕. History of unstable angina or myocardial infarction 1 mo prior to enrollment
✕. History of substance use disorder or abnormal urinary drug screen within the past year, or at risk of opioid abuse as determined by Screener and Opioid Assessment for Patients with Pain (SOAPP14) ≥7
What they're measuring
1
Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)