Dexamethasone Dyspnea Study

• Status: Completed
• Trial end date: 2021-01-26
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo.

Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Diagnosis of cancer

2. Dyspnea with an average intensity level >3/10 on the numeric rating scale over the past week

3. Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration

4. Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine

5. Able to communicate in English

6. Karnofsky performance status >=40%

7. Age 18 or older

8. Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial.

Exclusion Criteria:

1. Delirium (i.e. Memorial delirium rating scale >13)

2. Oxygen saturation <90% despite supplemental oxygen >6L/min

3. Previous allergic reactions to dexamethasone

4. Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past two weeks

5. Severe anemia (Hb <7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)

6. Post-surgical open wound that has not been healed at the time of enrollment

7. Any infection requiring parenteral antibiotics within the past 2 weeks

8. Major surgery within the past 2 weeks

9. Megestrol use at the time of study enrollment

10. Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)

11. Currently on or expected to start cytotoxic chemotherapy with in 1 week of study enrollment

12. Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment

13. Heart failure exacerbation at the time of study enrollment

14. Chronic systemic corticosteroid use (>14 days) at the time of study enrollment

15. Unwilling to provide informed consent