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Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study

NCT01797991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-10-31

No results posted yet for this study

Summary

This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study.

The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel.

Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.

Conditions

  • Prevention of Hypersensitivity Reactions to Paclitaxel

Interventions

DRUG

Dexamethasone per os

DRUG

Matching placebo for dexamethasone IV

DRUG

Dexamethasone IV

DRUG

Matching placebo for dexamethasone per os

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Vanessa Samouelian, M.D., Ph. D. · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

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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 NCT01797991 on ClinicalTrials.gov