Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Oral Ondansetron and Dexamethasone: Tab Ondansetron 8 mg or 0.15mg/kg Per Oral 1 hour before chemotherapy and then if required for CINV on day 2 to day 4
Tab Dexamethasone 12mg or 3mg p
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects aged 18 years and above ECOG PS 0 to 2 Treatment naïve newly diagnosed cancer patients Patients who will be receiving single day regimens of HEC containing AC anthracyclines and cyclophosphamide Cisplatin Dacarbazine and Actinomycin D Patient who are willing to sign a written informed consent and participate in the study
Exclusion criteria
Exclusion criteria: Vomiting retching or more than mild nausea within 24 hours before the start of chemotherapy Active infection or uncontrolled medical condition other than malignancy Severe cognitive compromise history of central nervous system disease eg cerebral hemorrhage cerebral infarction brain metastases or a seizure disorder Patients having serum creatinine 2mg per dl or more Patients with gastric surgery and small intestinal surgery or gastrointestinal obstruction Patients on Ryles tube or Patients who are unable to swallow Patients scheduled for or receiving radiotherapy Patients having an aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range and total bilirubin concentration of 2 mg per dL or more Patients with cardiac arrhythmia uncontrolled congestive heart failure or acute myocardial infarction within the previous 6 months Patients with history of uncontrolled diabetes mellitus Patients receiving medication that strongly induces CYP3A4 activity eg rifampicin phenytoin carbamazepine phenobarbital Patients with history of using any of the following drugs within 48 h before enrollment opioids aprepitant 5-HT3-RA dexamethasone dopamine receptor antagonists antihistamines benzodiazepines or phenothiazine antipsychotic agents Patients receiving Drugs other than chemotherapeutic agents with the potential to cause emesis Hypersensitivity to study drug: Known prior severe hypersensitivity to investigational product or any component in its formulations Pregnant patient or those with positive pregnancy test done using pregnancy test kit within 7 days before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve complete response in chemotherapy induced nausea and vomiting during the overall phase means 0 to 120 hours of receiving Highly emetogenic chemotherapyTimepoint: 0 to 120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 The proportion of patients who achieve a complete response in CINV during the acute phase 0 to 24 hours 2 The proportion of patients who achieve a complete response in CINV during the delayed phase 25 to 120 hours 3 The proportion of patients with breakthrough vomiting episodes during acute delayed and overall phases and need of rescue antiemetics 4 The proportion of patients with no nausea during acute delayed and overall phases 5 Proportion of patients achieving complete protection no vomiting no use of rescue medications and no nausea of CINV 6 Ascertain the side effects in each arm 7 Evaluate the cost effectiveness cost benefit and cost utility analysis of both the study arms for all enrolled patients Timepoint: 0 t0 24 hours 25 to 120 hours | — |
Countries
India
Contacts
Public ContactDr Deepam Pushpam
All india institute of medical sciences, New Delhi
Outcome results
None listed