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Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

NCT02349763 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2020-10-23

No results posted yet for this study

Summary

Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian, fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel and carboplatin.

Conditions

  • Hypersensitivity Reaction

Interventions

DRUG

Intravenous Dexamethasone

Lactose (Placebo) 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and dexamethasone 20 mg (5mg/ml) given intravenously at 30 minutes before paclitaxel infusion

DRUG

Oral Dexamethasone

Dexamethasone 20 mg (4 mg/tablet) or 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and 0.9% NaCL (Placebo) 4 ml given intravenously at 30 minutes before paclitaxel infusion

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Principal Investigators

  • Dr Marut Yanaranop, MD · Department of Medical Services Ministry of Public Health of Thailand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-30
Completion
2015-08-30

Countries

  • Thailand

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 NCT02349763 on ClinicalTrials.gov