To study effect of low-dose Vs standard-dose Olanzapine with standard regimen for prevention of chemotherapy induced nausea and vomiting.
- Conditions
- Health Condition 1: - Health Condition 2: M799- Soft tissue disorder, unspecified
- Registration Number
- CTRI/2021/01/030233
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 275
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>2.Complete control rate in the acute phase and delayed phase. <br/ ><br>3.Total Control rate in the acute phase, delayed phase, and overall <br/ ><br>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). <br/ ><br>5.Incidence of day time somnolence. <br/ ><br>Timepoint: 0–120 h