MedTrace Logo

Breakthrough Dyspnea Fentanyl Study in Cancer Patients

NCT01515566 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-08-22

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Fentanyl

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

OTHER

Placebo

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

OTHER

Walking Tests

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

BEHAVIORAL

Questionnaires

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Hui, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515566 on ClinicalTrials.gov