Dexamethasone in Controlling Dyspnea in Patients With Cancer (NCT03367156) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Dexamethasone in Controlling Dyspnea in Patients With Cancer
United States135 participantsStarted 2017-12-04
Plain-language summary
This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.
Who can participate
Age range
18 Years
Sex
ALL
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.
* Dyspnea with an average intensity \>= 4 on the dyspnea NRS (range 0-10) over the past week.
* Radiologic suspicion of thoracic involvement, such as primary or metastatic lung cancer, lymphangitic carcinomatosis, airway infiltration, lymphadenopathy, pleural or chest wall invasion.
* Seen at an outpatient clinic at MD Anderson Cancer Center or Lyndon B. Johnson (LBJ) Hospital General Oncology Clinic.
* Able to communicate in English or Spanish.
* Karnofsky performance status \>= 30%.
Exclusion Criteria:
* Delirium (i.e., score \> 13 on the Memorial Delirium Assessment Scale; range 1-30).
* Oxygen saturation \< 90% despite supplemental oxygen \> 6 L/minute.
* Previous allergic reactions to dexamethasone.
* Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.
* Postsurgical open wound that has not healed at the time of enrollment.
* Any infection requiring antibiotics at the time of study enrollment.
* Major surgery within the past 2 weeks.
* Megestrol use at the time of study enrollment.
* Neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
* Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy within 1 week of study enrollment and additional dexamethasone cannot be used concurrently as per attending oncologist.
* Severe anemia (hemoglobin \< 8 g/L) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity