Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

• Status: Recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fentanyl; Morphine

Criteria

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 60-370 mg for >= 1 week (wk), with stable (i.e. +/- 30%) regular dose over the last 3 days (d)

• Karnofsky performance status >= 40%

• Age >= 18 years (yrs)

• Able to complete study assessments

• Able to speak English or Spanish

• Reside within 50 miles of participating centers

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 month prior to enrollment

• Resting heart rate > 120 beats/min at enrollment

• Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at 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

• History of or known allergy to fentanyl or morphine sulfate

• Currently prescribed benzodiazepines

• Severe anemia (Hemoglobin [Hb] < 7 g/L) if documented in the last month and not corrected prior to study enrollment

• Bilirubin >=5 x upper limit of normal if documented in the last month and not lowered to < 5 x normal prior to enrollment

• Diagnosis of acute pulmonary embolism within past 2 weeks

• Diagnosis of pulmonary hypertension

• Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 weeks

• Unwilling to provide informed consent