Prophylactic effect of mirtazapine for carboplatin-induced nausea and vomiting

Phase 2

Recruiting

• Conditions: Thoracic cancer; Thoracic Neoplasms; D013899

• Registration Number: JPRN-jRCTs041220042
• Lead Sponsor: Endo Junki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1) Thoracic cancer patients
2) Patients received CBDCA (AUC 4) based chemotherapy
3) 20 age old over and less than 80 age old at time of enrolment
4) Eastern Cooperative Oncology Group performance status of 0, 1 or 2
5) No history of administration of moderate-to-high emetogenic chemotherapy drugs
6) Within 48 hours prior to enrolment, no current use of any drugs with antiemetic or somnolent activity, including 5-HT3RA, NK1RA, corticostroids, dopamine receptor antagonists, phenothiazine tranquillisers, antihistamine drugs (paclitaxel administra
tion allowed during premedication) and benzodiazepine agents
7) Within a month prior to enrolment, within the following standard ranges for general clinical test T-bil: 2.0 mg/dL and less than, AST: 100 U/L and less than, ALT: 100 U/L and less than, Ccr: 40 mL/min and over
8) Provided written informed consent

Exclusion Criteria

1) History of hypersensitivity or allergy to study drugs or similar compounds
2) Need for antiemetics at the time of enrolment
3) Started opopod intake within 48 hours prior to enrolment
4) Presence of unstable angina, ischemic heart disease, cerebral hemorrahage or
apoplexy, or active gastric or duodental ulcer within 6 months prior to enrolment
5) Presence of convulsive disorders requiring anticonvulsant therapy
6) Presence of gastrointestinal obstruction
7) Breastfeeding or pregnant women or those not willing to use contraception
8) Presence of psychosis or psychiatric symptoms that interfere with daily life
9) Being a habitual smoker at the time of enrolment
10) Patients deemed inappropriate for the study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CR rate during the delayed phase (24-120 hours after administration of CBDCA)

Secondary Outcome Measures

Name	Time	Method
CR rate during the overall and acute phase,<br>CC rate during acute, delated and overall phase,<br>TC rate during acute, delated and overall phase,<br>Nausea,<br>Anorexia,<br>Somnolence,<br>Adverse events<br>The levels of nausea, vomiting, concentration, anorexia, taste changes, dry mouth, hiccups, constipation, diarrhea, dizziness, sleepiness, impact on life severity are also <br>classified using a PRO-CTCAE & trade JAPANESE. These data are collected from <br>patient diaries.<br>Patient satisfaction with antiemetic therapy