Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-06 @ 6:42 AM
Study NCT ID:
NCT03367156
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexamethasone in Controlling Dyspnea in Patients With Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: