Malignancy treated with chemotherapy containing carboplatin
Conditions
Interventions
aprepitant (day1:125mg, day2,3:80mg)+ granisetron 3 mg + dexamethasone (day1:6.6mgIV, day2,3:2mgPOX2)
palonosetron 0.75 mg + dexamethasone(day1:9.9mgIV, day2,3:4mgPOX2)
Sponsors
Kyushu Medical Center Clinical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: >=20 years. 2) Gender: Not specified. 3) Cancer patients receiving chemotherapy containing carboplatin (AUC >=4) for the first time. 4) Stage: Not specified (not specified with respect to postoperative adjuvant chemotherapy and advanced/recurrent cancer). 5) Combined use of molecular-targeting drugs: Not specified. 6) Patients from whom consent to participation in this study is obtained in writing.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete protection (no vomiting, therapeutic intervention, or significant nausea) during the 1st course of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of patients with complete protection (CP: no vomiting, therapeutic intervention, or moderate to severe nausea) from the 2nd course of chemotherapy. 2) Percentage of patients with a complete response (CR: no vomiting or therapeutic intervention). 3) Percentage of patients with complete control (CC: no vomiting, therapeutic intervention, or nausea). 4) Percentage of patients without vomiting. 5) Percentage of patients without therapeutic intervention. 6) Percentage of patients without nausea. 7) Percentage of patients without significant nausea (CTCAE[ver.4] grade >=2). 8) Evaluation of the quality of life (QOL) related to nausea by using the Functional Living Index-Emesis (FLIE) questionnaire. 9) Food intake. 10) Total cost of medications (prevention + therapeutic intervention) for nausea/vomiting. 11) Percentage of patients continuing treatment. 12) Changes of nausea and vomiting (CP, CR, CC, etc.) over time (courses of chemotherapy). 13) Time-to-treatment failure (TTF: time to the first episode of vomiting). | — |
Countries
Japan
Contacts
Public ContactKeita Uchino
Kyushu Medical Center Clinical Research Institute
Outcome results
None listed