CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Dexamethasone +4 moredrug
Likely dose
Dexamethasone 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01670097
NCT01670097Phase 2Completed

A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients

M.D. Anderson Cancer Center·interventional·Posted Aug 21, 2012·Updated Feb 17, 2021

In Brief

A Phase 2 clinical trial evaluating Dexamethasone, Placebo, and 3 other interventions for Advanced Cancers and 2 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 21, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2020
Study CompletionJan 26, 2021
TodayJul 1, 2026
Enrollment to primary: 7.6 yearsPosted 13.9 years ago

Interventions

Dexamethasonedrug

Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.

Placebodrug

Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.

Questionnairesbehavioral

Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Spirometerdevice

Patient to blow into spirometry machine 1 time a day to test lung function.

Phone Callsother

Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.