study to observe effect of aprepitant for prevention of nausea and vomiting
- Conditions
- histologically confirmed malignancies on HEC/MEC regime
- Registration Number
- CTRI/2013/05/003629
- Lead Sponsor
- Glenmark Pharmaceuticals ltd
- Brief Summary
xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /**Study Plan**
Patients will be recruited based on the inclusion and exclusion criteria. Written, informed consent will be obtained from eligible patients after a thorough explanation of the study. Detailed history of the patients along with physical examination of the patient will be performed at the baseline. The patients will be evaluated on the basis of episodes of nausea and vomiting during the treatment.
**Study Procedure**
Aprepitant capsules are given as 3 doses over 3 days - starting on the day of chemotherapy, and the two days after chemotherapy with aprepitant given as 125mg administered 1 hour prior to initiating chemotherapy treatment (day 1) and 80mg once daily on days 2 and 3. Aprepitant may be taken with or without food. Along with aprepitant patient will receive 5HT3 receptor antagonist and dexamethasone.
Aprepitant, a dose-dependent inhibitor of CYP3A4, should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Moderate inhibition of CYP3A4 by aprepitant, 125 mg/80 mg regimen, could result in elevated plasma concentrations of these concomitant medications. When aprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When Aprepitant is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced and this may result in decreased efficacy of Aprepitant. Coadministration of Aprepitant with warfarin may result in a clinically significant decrease in International Normalized Ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of Aprepitant with each chemotherapy cycle. Upon coadministration with Aprepitant, the efficacy of hormonal contraceptives during and for 28 days following the last dose of Aprepitant may be reduced. Alternative or back-up methods of contraception should be used during treatment with Aprepitant and for 1 month following the last dose of Aprepitant. You should inform your physician regarding any drug treatment taken by you. The study involves following activities – history, physical examination & lab investigations. You will be interviewed and examined periodically, the dates of which will be informed to you well in advance by your treating doctor. At the 1st visit, the treating doctor will do a brief physical examination and take your related medical history. As per eligibility you will be enrolled in the study then drugs will be administered. The adverse event monitoring will be done as per follow up visit.
You should not donate blood or take any other medication during the study period unless the doctor says so. This includes over the counter medications. If you do so, you must inform the doctor at your next visit. In such a case, you are liable to be withdrawn from the study.
***Clinical Efficacy Assessment***
The primary efficacy endpoint was the proportion of patients reporting no vomiting during the 5 days following initiation of chemotherapy. The key secondary efficacy endpoint was the overall complete response (no emetic episodes and no administration of rescue therapy) during the 5 days (120 h) following the initiation of chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 1000
- •Male and female subject’s ≥ 18 years of age.
- •Patients with either MEC or HEC regimens •Patients with histologically confirmed malignancies •Karnofsky scores ≥ 60 •Predicted life expectancy ≥ 4 months.
- •Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed •Patients with symptomatic primary or metastatic central nervous system malignancy •Patients who had received or were to receive radiation therapy to the abdomen or pelvis in the week prior to treatment •Patients who had vomited in the 24 hr prior to treatment •Patients who had an active infection or any uncontrolled disease other than malignancy Abnormal laboratory values (absolute neutrophil count 1,500/mm3, white blood cell count 3,000/mm3, platelet count 100,000/mm3, aspartate transaminase 2.5× upper limit of normal, alanine transaminase 2.5× upper limit of normal, bilirubin 1.5× upper limit of normal, creatinine 1.5× upper limit of normal).
- •Patients taking systemic steroid therapy at any dose.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients reporting no vomiting 5 days following initiation of chemotherapy
- Secondary Outcome Measures
Name Time Method overall complete response (no emetic episodes and no administration of rescue therapy) 5 days (120 h) following the initiation of chemotherapy.
Trial Locations
- Locations (1)
Deshmukh Clinic and research centre
🇮🇳Pune, MAHARASHTRA, India
Deshmukh Clinic and research centre🇮🇳Pune, MAHARASHTRA, IndiaDr Chetan DeshmukhPrincipal investigator9850811449drchetandeshmukh@gmail.com