Prospective, open-label, comparative study on the efficacy of triple (aprepitant + granisetron 3 mg + dexamethasone) versus double (palonosetron 0.75 mg + dexamethasone) combination therapy for nausea and vomiting during moderately emetogenic chemotherapy containing carboplatin: CAP Study
- Conditions
- Malignancy treated with chemotherapy containing carboplatin
- Registration Number
- JPRN-UMIN000010186
- Lead Sponsor
- Kyushu Medical Center Clinical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
1)Patients with serious hepatopathy or nephropathy. 2)Patients suffering from nausea or vomiting within 24 hours before the start of chemotherapy. 3)Patients receiving antiemetic drugs within 24 hours before the start of chemotherapy. 4)Patients with emetogenic factors other than chemotherapy (such as brain tumor, gastrointestinal obstruction, active peptic ulcer, and brain metastasis). 5)Patients who have received radiation therapy or are scheduled to receive it to the abdominal region or pelvis within 1 week before or after the start of the study. 6)Patients with concomitant diseases that make 3-day dexamethasone therapy impossible, such as uncontrolled diabetes mellitus. 7)Pregnant women, women who wish to become pregnant, and breast-feeding women. 8)Patients on treatment with pimozide. 9)Other patients whom the investigator considers to be unfit for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with complete protection (no vomiting, therapeutic intervention, or significant nausea) during the 1st course of treatment.
- Secondary Outcome Measures
Name Time Method