Health Condition 1: - Health Condition 2: M799- Soft tissue disorder, unspecified
Conditions
Interventions
Intervention1: low dose olanzapine (2.5 mg) Dose: 2.5mg
Route of administration: Oral
Frequency: once daily: This study does not involve the administration of any additional drugs beyond those being
however, low dose 2.5 mg is also widely used in clinical practice including in Tata Memorial Centre.
Control Intervention1: standard dose olanzapine (10 mg)
Dose: 10 mg Route of administration: Oral F
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients with 1.Solid malignant tumor. 2.No prior to chemotherapy. 3.Scheduled for treatment with cisplatin or anthracycline-cyclophosphamide based chemotherapy (either cisplatin at a dose =70 mg per square meter of body-surface area, with or without other chemotherapeutic agents, or doxorubicin at a dose of 60 mg per square meter plus cyclophosphamide at a dose of 600 mg per square meter). 4.ECOG performance status of 0 to 2. 5.Aged =13 –75years. 6.Adequate organ function. 7.Able to understand and describe patient-reported outcomes.
Exclusion criteria
Exclusion criteria: 1.A history of hypersensitivity or allergy to any of the study drugs or similar compounds. 2.Current treatment for nausea or vomiting. 3.Symptomatic brain metastases. 4.Pregnant or breastfeeding women and women of childbearing potential, as well as men wishing to father of children. 5.Subjects scheduled for abdominal or pelvic radiotherapy. 6.Subjects requiring treatment for ascites or pleural effusion. 7.Gastrointestinal obstruction. 8.Known psychiatric illnesses and on active antipsychotic treatment 9.Subjects on anticonvulsant therapy. 10.Uncontrolled Diabetes mellitus (defined as with use of antidiabetic agents and HbA1c(NGSP) =6.5% or HbA1c (JDS) =6.1%). 11.A 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. 12.Habitual smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The primary endpoint is no nausea rate (0-120 h) which was defined as the proportion of subjects with no vomiting, no use of rescue medications, and no or mild nauseaTimepoint: Baseline, Day-1, Day2 to Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate( no emetic episode and no use of rescue antiemetic medication ) in the acute phase (0–24 h) , delayed phase (0–120 h) and overall 2. Complete control rate in the acute phase and delayed phase. 3. Total Control rate in the acute phase, delayed phase, and overall 4. Time to treatment failure (defined as the time from Cisplatin or anthracycline administration to an episode of vomiting or the use of rescue medication). 5. Incidence of day time somnolence. Timepoint: 0–120 h | — |
Countries
India
Contacts
Public ContactDr Jyoti Bajpai
Tata Memorial Center
Outcome results
None listed