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Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy

NCT03674294 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2023-02-08

No results posted yet for this study

Summary

The purpose of this study is to study whether adding Aprepitant to Palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI or FOLFOX chemotherapy regimen among gastrointestinal malignancy patients with high risk factors of chemotherapy-associated adverse events.

Conditions

  • Gastrointestinal Neoplasms
  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Aprepitant

Aprepitant is manufactured by Merck \& Co. for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting. It was approved by the FDA in 2003

DRUG

Palonosetron

Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is used for the control of delayed CINV-nausea and vomiting and there are tentative data to suggest that it may be more effective than granisetron.

DRUG

Dexamethasone

Dexamethasone is a type of corticosteroid medication. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.

DRUG

Placebo Oral Tablet

In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2020-03-31
Completion
2020-06-01

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT03674294 on ClinicalTrials.gov