Comparison of the effectiveness of olanzapine, metoclopramide and domperidone for controlling chemotherapy related nausea and vomiting

Phase 2/3

Recruiting

• Conditions: Neoplasms,

• Registration Number: CTRI/2018/11/016359
• Lead Sponsor: Jawaharlal Institute Of Postgraduate Medical Education and Research

Brief Summary

This trial is being conducted to identify the appropriate drug for chemotherapy induced breakthrough nausea and vomiting. Such trials comparing multiple drugs for controlling breakthrough nausea vomiting have not been done in Indian subcontinent. Presently there is no standard drug for break through emesis in both highly and moderately emetogenic chemotherapy induced breakthrough nausea and vomiting.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-16
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.Histologically or cytologically confirmed malignant disease 2.Chemotherapy naïve patients 3.Scheduled to receive intravenous either single or multiday highly emetogenetic chemotherapy regimens or moderately emetogenic chemotherapy regimens.

Exclusion Criteria

• 1.Patients with nausea in 24 h prior to beginning of chemotherapy 2.serum creatinine of >2.0 mg/dl, serum bilirubin of >2.0 mg/dl, SGOT or SGPT values of >3 times the upper limits of normal 3.Pregnant patients 4.Patients on chemotherapy for leukemia.
• 5.Esophageal and stomach malignancies are excluded from the study.
• 6.Patients on continuous, intermittent or concomitant oral chemotherapy 7.Patients on continuous, intermittent or concomitant oral chemotherapy or on opioid (morphine) treatment for pain control.
• 8.Patients with known hypersensitivity to olanzapine, metoclopramide or domperidone, 9.Patients with cardiac arrhythmia, history of congestive heart failure, or acute myocardial infarction within the previous 6 months.
• 10.Patients with known history of CNS disease (e.g., brain metastases, seizure disorder), or treatment with any antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for 30 days prior to or during protocol therapy.
• 11.Patients with concurrent abdominal radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the efficacy of metoclopramide, olanzapine, domperidone in symptom abolishment of chemotherapy induced breakthrough nausea and vomiting	over 1 year of DM course

Secondary Outcome Measures

Name	Time	Method
To assess the use of second line rescue for treatment of breakthrough emesis	over 1 year of DM course
To assess and compare QOL before and after onset of breakthrough CINV and use of study medications	over 1 year of DM course
To assess and compare the side effect profile of metoclopramide, olanzapine, domperidone in the treatment of breakthrough vomiting	over 1 year of DM course

Trial Locations

Locations (1)

Jawaharlal institute of post graduate medical education and research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal institute of post graduate medical education and research

🇮🇳Pondicherry, PONDICHERRY, India

Bhanu Prakash Bandlamudi

Principal investigator

7760356346

bhanu691@gmail.com