Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy

Phase 3

Recruiting

• Conditions: Breast Cancer

• Registration Number: JPRN-UMIN000007882
• Lead Sponsor: Juntendo Clinical Research Support Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-02
• Study Completion: 2015-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a history of administration of moderate to high emetogenic chemotherapy 2) Patients receiving administration of an antiemetic drug (5-HT3 receptor antagonist, phenothiazine, butyrophenone, benzamide, or dopamine receptor antagonist) 3) Patients who received administration of a benzodiazepine or narcotic formulation within 48 hours before commencement of AC therapy 4) Patients who received systemic corticosteroid therapy within 72 hours before commencement of AC therapy 5) Patients with a history of gastrointestinal tract surgery (excluding appendectomy) 6) Patients who received or are scheduled to receive radiation therapy for the abdominal region (diaphragm or lower) or pelvis for a period from 6 days before commencement of AC therapy until Day 6 of AC therapy 7) Patients who had vomiting or dry vomiting within 24 hours before commencement of AC therapy 8) Patients with active multiple cancer (synchronous multiple cancer or metachronous multiple cancer with a disease-free interval of 5 years or less) 9) Patients with a symptomatic cerebral tumor (including a benign tumor) 10) Patients who received administration of the following drugs within 7 days before commencement of AC therapy: clarithromycin, erythromycin, ketoconazole, itraconazole, and digoxin 11) Patients who received administration of the following drugs within 4 weeks before commencement of AC therapy: barbiturate drug, rifampicin, phenytoin, and carbamazepine 12) Pregnant or lactating patients, patients who may be pregnant, patients hoping to become pregnant during the study period, and patients taking an oral contraceptive 13) Patients who have coexisting diseases, such as systemic infection, hepatitis, and uncontrollable diabetes, in whom dexamethasone sodium phosphate cannot be administered 14) Patients with a history of hypersensitivity to granisetron, palonosetron, aprepitant or dexamethasone 15) Other patients who are judged to be inappropriate for the study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients who showed complete response (no vomiting and no salvage treatment) during a period from 24 to 120 hours after AC therapy

Secondary Outcome Measures

Name	Time	Method
(1)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 24 hours of AC therapy (2)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 120 hours of AC therapy (3)proportion of patients who showed no nausea / degree of nausea (4)QOL (5)Dietary intake (6)Adverse events