Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04188418
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of cancer with evidence of active disease
2. Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale
3. Outpatient at participating centers
4. Ambulatory and able to walk, with or without walking aid
5. 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
6. Karnofsky performance status ≥40%
7. Age ≥18 yrs
8. Able to complete study assessments
9. Able to speak English or Spanish
10. Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month
Exclusion Criteria:
1. Dyspnea at rest ≥7/10 on modified Borg scale at enrollment
2. Supplemental oxygen requirement \>6 L/min
3. Delirium (i.e. Memorial Delirium Assessment Scale ≥13)
4. History of unstable angina or myocardial infarction 1 mo prior to enrollment
5. Hemodynamic instability requiring hospitalization
6. 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
7. History of or known allergy to fentanyl or morphine sulfate
8. Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study
9. Severe anemia (Hb \<7 g/L) if documented in the last month and not corrected prior to study enrollment\*
10. Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to \<5x normal prior to enrollment\*
11. Diagnosis of acute pulmonary embolism within past 2 wks
12. Diagnosis of pulmonary hypertension
13. Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks
14. Currently pregnant or breastfeeding
15. Unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04188418
Study Brief:
Protocol Section:
NCT04188418