Activity of steroid free therapy for control of vomiting
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2021/07/034813
- Lead Sponsor
- CI AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 101
a. Diagnosis of malignancy
b. No prior chemotherapy and radiation therapy (RT)
c. Age of ââ?°Â¥ 18 ââ?¬â?? up to 70 years
d. ECOG Performance status (0-2)
e. Complete hemogram (ANC �1000/m3, TLC �3000/m3, Platelets � 1,00,000/m3), Creatinine (� 2 mg/dl), SGOT / SGPT (� 3 X ULN, Bilirubin <2.0 mg/dl)
f. First cycle of highly emetogenic chemotherapy defined as
1. Cisplatin at dose �70mg/m2 with or without other agents
2. Single agent Anthracycline (Doxorubicin � 60mg/m2, Epirubicin � 90mg/m2)
3. AC (Doxorubicin � 60mg/m2, Epirubicin � 90mg/m2 + Cyclophosphamide �
600mg/m2)
4. Dacarbazine based therapy (ABVD)
g. Willing to give written informed consent for the study participation
h. Able to read and write in English or Hindi
a. Patient receiving concurrent quinolone, amifostine, warfarin, OCP, psychiatric drugs, Benzodiazepines, Anti-convulsant drugs, strong or moderate CYP3A4 inhibitors (diltiazem, Ketoconazole), strong CYP3A4 inducers (rifampicin), pimozide, cisapride, terfenadine, astemizole, CYP1A2 inhibitors (ciprofloxacin, fluvoxamine)
b. History of chronic alcoholism
c. Hypersensitivity to any of the drugs used in the study {Olanzapine, NK-1 antagonist (Fosaprepitant), 5-HT3 antagonist ââ?¬â?? Ondansetron}
d. On systemic steroids, active smoker
e. History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis, psychiatric disorder
f. Symptomatic Brain metastasis / Carcinomatous Meningitis
g. History of nausea and vomiting in 24 hours prior to first dose of chemotherapy
i. Use of anti-emetic drugs (5-HT3 Antagonist) in last 48 hours
j. Started on opioids in last 48 hours
l. Female who are pregnant, lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving highly emetogenic chemotherapyTimepoint: At 24 hours, 120 hours
- Secondary Outcome Measures
Name Time Method To determine the feasibility of accrual and success of completion of outcome measure <br/ ><br>To determine the rate of complete response during the acute period (0-24 hours), delayed period (24 ââ?¬â?? 120 hours) <br/ ><br>To determine the rate of nausea control during the acute period (0-24 hours), delayed period (24 ââ?¬â?? 120 hours) and overall period (0-120 hours) <br/ ><br>To determine the rate of total control and complete control during the OP <br/ ><br>Toxicity pattern and incidence <br/ ><br>Time to treatment failureTimepoint: 6 months