Health Condition 1: null- Chemotherapy Induced Nausea and Vomiting due to Moderate Emetogenic and Mild Emetogenic Chemotherapeutic Agents
Conditions
Interventions
Intervention1: Granisetron: On Day 1
Intravenous injections of IV Granisetron 1 mg plus IV Dexamethasone 8 mg is given 30 mins before administration of Moderate emetogenic and mild emetogenic Chemoth
Sponsors
Dr Nenavath Vinay
Eligibility
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Complete Prevention of Emesis 2.Complete Prevention of Nausea 3.Adverse events during study 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 Complete prevention of nausea and vomiting at the end of 5 days Adverse events in 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| No. of Emetic Episodes No. of patients with treatment failure (Taken rescue medication) Total Cost of Treatment per patient in each group Functional Living index of every patient Body Weight changes at the end of day 5Timepoint: At the end of Day 5 | — |
Countries
India
Contacts
Public ContactDr M Manickavasagam
Sri Ramachandra Medical College and Research Institute, Chennai
Outcome results
None listed