CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Fentanyl +3 moredrug
Likely dose
Not stated in 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/NCT01515566
NCT01515566Phase 2Completed

Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial

M.D. Anderson Cancer Center·interventional·Posted Jan 24, 2012·Updated Aug 22, 2014

In Brief

A Phase 2 clinical trial evaluating Fentanyl, Placebo, and 2 other interventions for Advanced Cancers and Dyspnea. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well. 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
201220132014201520162017201820192020202120222023202420252026
First PostedJan 24, 2012
Enrollment StartApr 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.4 years ago

Interventions

Fentanyldrug

Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.

Placeboother

Normal saline 0.9% preservative free SQ 15 minutes before walk test.

Walking Testsother

6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.

Questionnairesbehavioral

Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.