MedTrace Logo

Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

NCT03478605 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-07-05

No results posted yet for this study

Summary

Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.

Conditions

  • Emesis
  • Vomiting
  • Nausea Post Chemotherapy
  • Nausea
  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Olanzapine

Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)

DRUG

Aprepitant Pill

Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.

DRUG

Ondansetron

Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)

DRUG

Dexamethasone

Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy)

Sponsors & Collaborators

  • RUSSCO/RakFond

    collaborator UNKNOWN

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2019-05-25
Completion
2019-06-01

Countries

  • Russia

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 NCT03478605 on ClinicalTrials.gov