Prophylactic effect of mirtazapine for carboplatin-induced nausea and vomiting

JRCT ID: jRCTs041220042

Registered date:13/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Thoracic cancer
• Date of first enrollment: 18/08/2022
• Target sample size: 51
• Study type: Interventional

Intervention(s)

All patients received granisetron (1mg intravenous infusion on day 1, 30 min before chemotherapy), dexamethasone (9.9mg intravenous infusion or 12 mg oral administration on day 1, 6.6 mg intravenous infusion or 8 mg oral administration on day 2 and 3, 30 min before chemotherapy) and mirtazapine (15 mg oral administration on day 1-4, before bed
time)

Outcome(s)

• Primary Outcome: CR rate during the delayed phase (24-120 hours after administration of CBDCA)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Endo Junki
• Secondary Sponsor: Suzuki Akio