NCT03367156

Dexamethasone in Controlling Dyspnea in Patients With Cancer

A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Compare the intensity of dyspnea (numeric rating scale \[NRS\]) in the dexamethasone arm with that in the placebo arm at week 1. SECONDARY OBJECTIVES: I. Compare the effects of dexamethasone with those of placebo in terms of personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week 2, as well as the intensity of dyspnea at week 2. II. Identify predictive markers of dyspnea response to dexamethasone. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-28 in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at days 28 and 42.

Conditions

• Dyspnea
• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-12-04
• Primary completion: 2021-05-05
• Completion: 2025-12-31
• First posted: 2017-12-08
• Last updated: 2025-11-12
• Results posted: 2022-12-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study