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:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-24 @ 4:00 PM
NCT ID:
NCT01515566
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of cancer
2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \>=3/10 on the numeric rating scale
3. Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
4. Able to communicate in English or Spanish
5. Ambulatory and able to walk with or without walking aid
6. On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
7. Karnofsky performance status \>=50%
8. Age 18 or older
Exclusion Criteria:
1. Dyspnea at rest \>=7/10 at the time of enrollment
2. Supplemental oxygen requirement \>6 L per minute
3. Delirium (i.e. Memorial delirium rating scale \>13)
4. History of unstable angina or myocardial infarction 1 month prior to study enrollment
5. Resting heart rate \>120 at the time of study enrollment
6. Systolic pressure \>180 mmHg or diastolic pressure \>100 mmHg at the time of study enrollment
7. History of active substance abuse within the past 12 months
8. History of allergy to fentanyl
9. Unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01515566
Study Brief:
Protocol Section:
NCT01515566