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Double-blind comparative randomized Japanese trial of triplet antiemetic therapies with or without 5mg Olanzapine for AC therapy

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Breast Cancer
Date of first enrollment	26/10/2020
Target sample size	500
Countries of recruitment
Study type	Interventional
Intervention(s)	Olanzapine as a prevention of CINV for AC therapy

Outcome(s)

Primary Outcome

Complete Response for all course

Secondary Outcome

1. CR rate for the assessment periods (0-24 h, 25-120 h, 25-168 h and 0-168 h) 2. Complete control rate for the assessment periods (0-24 h, 25-120 h, 25-168 h, 0-120 h and 0-168 h) 3. Total control rate for the assessment periods (0-24 h, 25-120 h, 25-168 h, 0-120 h and 0-168 h) 4. Time to treatment failure 5. Severity of nausea (assessed by the patient's own four-grade categorical scale) 6. Appetite loss (assessed by the patient's own four-grade categorical scale) 7. Sleepiness in the daytime, and the incidence of concentration impairment due to sleepiness (assessed by the patient's own four-grade categorical scale) 8. Subjective evaluation by the patient (refer to PRO-CTCAE & trade Trademark Symbol Japanese version) Nausea, vomiting, concentration impairment, loss of appetite, unclear (or changed taste) taste of food or drink, dry mouth, hiccups, constipation, diarrhea (loose stool or watery) Stool), dizziness, sleeplessness 9. Adverse event occurrence rate 10. Satisfaction with antiemetic therapy (assessed by the patient's own seven-grade categorical scale)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Female
Include criteria	1) Patients with primary breast cancer Stage I to III 2) Receiving 1st AC therapy 3) Female 4) The age of registration is 20 years or older. 5) ECOG performance status (PS): 0-1 6) No history of chemotherapy with moderate or higher emetic risk. 7) Do not use any of the prohibited drugs within 48 hours before registration. 8) The latest test value within one month before registration satisfies all of the following. A) T-bil<=2.0mg/dL B) AST<=100U/L C) ALT<=100U/L 9) Informed consent is obtained in writing from the patient.
Exclude criteria	1) Patients with a history of allergy to the drugs or similar compounds used in this study. 2) Patients with nausea and vomiting that require antiemetic measures at the time of registration. 3) Patients who started strong opioid within 48 hours before registration. 4) Patients with a history of one or more of unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, and active gastric/duodenal ulcer within 6 months before enrollment. 5) Patients with convulsive disorders requiring treatment with anticonvulsants. 6) Patients with gastrointestinal obstruction such as gastric pyloric stenosis or intestinal obstruction. 7) Women who are pregnant, breastfeeding or may be pregnant or are not willing to contracept. 8) Patients who have mental illness or psychiatric symptoms that interfere with daily life and are considered to be difficult to participate in the study. 9) Diabetic patients who have been treated with at least one of insulin and oral hypoglycemic agents, and patients with HbA1c (NGSP) of 6.5% or more and HbA1c (JDS) of 6.1% or more at the time of registration. In addition to the prescribed tests, patients who may measure blood glucose and thereby reduce or discontinue dexamethasone will also be excluded. 10) Patients who have smoking habits at the time of registration. 11) In addition, patients who were judged to be unsuitable for participation in this study.