Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT04188418

Run by

M.D. Anderson Cancer Center

People needed

150

Starts

2020-10-23

Expected to finish

2027-08-31

Last updated by the study team

2026-02-19

Who can join

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

You may qualify if…

• 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
• Able to speak English or Spanish
• Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month

You may not qualify if…

• 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
• Hemodynamic instability requiring hospitalization
• 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
• History of or known allergy to fentanyl or morphine sulfate
• Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study
• Severe anemia (Hb <7 g/L) if documented in the last month and not corrected prior to study enrollment*
• Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to <5x normal prior to enrollment*
• Diagnosis of acute pulmonary embolism within past 2 wks
• Diagnosis of pulmonary hypertension
• Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks
• Currently pregnant or breastfeeding
• Unwilling to provide informed consent

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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