Effect of Granisetron and Ondansetron in Prevention of nausea and vomiting in Cancer patients

Phase 3

Completed

• Conditions: Health Condition 1: null- Chemotherapy Induced Nausea and Vomiting due to Moderate Emetogenic and Mild Emetogenic Chemotherapeutic Agents

• Registration Number: CTRI/2017/10/010163
• Lead Sponsor: Dr Nenavath Vinay

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

Inclusion Criteria:

1.Patients aged between 20 yrs and 65 yrs of both sexes at the time when they are giving consent

2.Diagnosed as cancer patients by the Medical Oncologist are only taken for the study

3.Be naïve to chemotherapy or been treated with single cycle of Chemotherapy with Moderate Emetogenicity and Low emetogenicity Chemotherapeutic agents

4.Patient who were scheduled to receive chemotherapy with any dose of Moderate or Low emetogenic potential chemotherapeutic agents except Carboplatin

Exclusion Criteria

Exclusion Criteria:

1.Known Allergic to Ondansetron or Granisetron or Dexamethasone

2.Patients who are too sick to give informed consent

3.Patients having baseline prolong QTc interval with arrythmias and conduction defects

4.Patients with Severe and uncontrollable complications

5.Patients with abnormal Serum levels of Potassium, Calcium and Magnesium will be excluded

6.Patients with Metastasis to brain which are symptomatic

7.Patients with Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity

8.Symptomatic or invasive procedure indicated ascites or pleural effusion

9.Patients having either gastric outlet stenosis or intestinal obstruction

10.Patients having Ongoing emesis or greater nausea

11.Liver failure and Kidney failure patients

12.Pregnant women and Lactating mothers

13.Any male or female who is not willing to practice adequate contraceptive measures during the study period

14.Subject who is currently enrolled in another investigational drug study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Complete Prevention of Emesis <br/ ><br>2.Complete Prevention of Nausea <br/ ><br>3.Adverse events during study <br/ ><br>4.Electrocardiographic changes before and after treatmentTimepoint: ECG Changes at time points of 5 mins, 15 mins, 1 hour and 2 hours after treatment in 1 day <br/ ><br>Complete prevention of nausea and vomiting at the end of 5 days <br/ ><br>Adverse events in 5 days

Secondary Outcome Measures

Name	Time	Method
o. of Emetic Episodes <br/ ><br>No. of patients with treatment failure (Taken rescue medication) <br/ ><br>Total Cost of Treatment per patient in each group <br/ ><br>Functional Living index of every patient <br/ ><br>Body Weight changes at the end of day 5Timepoint: At the end of Day 5