A randomized phase II study comparing the antiemetic effects of Granisetron and Granisetron + ME2136 in the perioperative management of patients undergoing pulmonary resection with a moderate to high risk of developing PONV

JRCT ID: jRCT2041240130

Registered date:25/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 09/12/2024
• Target sample size: 64
• Study type: Interventional

Intervention(s)

Treatment group
Administer GRA 1mg intravenously or intravenous drip at the end of the surgery. In addition to that, administer ME2136 (5mg) sublingually twice a day after dinner for 5 days from the evening of day 1, the day before the scheduled surgery, to day 5.
(It can be administered even if food intake is not possible due to pre- and post-operative dietary restrictions or anorexia.)

Standard group
Administer GRA 1mg intravenously or intravenous drip at the end of the surgery.

Outcome(s)

• Primary Outcome: Complete response within 24 hours after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients scheduled to undergo anatomical lung resection (subsegmentectomy, segmentectomy, lobectomy, bilobectomy, pneumonectomy, or a combination of these procedures, or a combination of these procedures and partial wedge resection) requiring general anesthesia with endotracheal intubation for lung cancer (including suspected malignancy).
(2) Aged 18 years or older at the time of obtaining consent.
(3) ECOG Performance status (PS) of 0-2.
(4) Apfel simplified risk score of 2 or higher. (Note: 1 point each for "female," "history of PONV or motion sickness," "non-smoker," and "postoperative opioid use (including planned)"; 0 points if not applicable. Patients with a total score of 2 or more out of these 4 items).
(5) Not planning to use any of the following concomitant medications within 48 hours before general anesthesia (scheduled surgery admission time): NK1 receptor antagonist, 5-HT3 receptor antagonist, anti-dopamine drug, phenothiazine drug, barbituric acid drug, multi-acting receptor-targeted antipsychotic (MARTA) (excluding ME2136 for protocol treatment).
(6) Patients who have signed the informed consent regarding participation in this trial.
(7) Patients judged by the investigator or sub-investigator as having organ functions and general conditions acceptable for safe performance of general anesthesia.
(8) Patients who have agreed to keep a symptom diary during the clinical trial.

Exclude criteria

(1) Patients with a history of allergy to the drug used in this trial and similar compounds
(2) Patients with a history of type 1 diabetes.
(3) Patients with poorly controlled type 2 diabetes or hyperglycemia.
Specifically, those who do not meet any of the following conditions (A) to (C) (blood glucose levels must be measured within 14 days prior to registration [the same day of the week two weeks prior is acceptable], and HbA1c within 90 days prior to registration).
(A) Diagnosed with type 2 diabetes and meeting the following criteria in the pre-registration examination: HbA1c <8.0% (NGSP value) and fasting blood glucose* <250 mg/dl or any time blood glucose <300 mg/dl.
*The "fasting blood glucose" is defined as the blood glucose level measured in the fasted state after fasting for 10 hours or longer.
(B) 126 mg/dl <=fasting blood glucose <250 mg /dl and 6.5% <= HbA1c <8.0% (NGSP value) in pre-registration tests
(C) 200 mg/dl <= blood glucose <300 mg/dl and 6.5% <=HbA1c <8.0% (NGSP value) in pre-registration tests
Note that in this trial, subjects who meet any of the above (A) to (C) are defined as the "DM group".
(4) Patients with nausea that requires treatment with antiemetics at the time of screening, or with symptoms such as Nausea and vomiting (including dry vomiting) due to opioids or underlying diseases
(5) Patients who have suffered from any of the following within 6 months from the date of consent: unstable angina, myocardial infarction, cerebral hemorrhage, or cerebral infarction requiring treatment (lacunar infarction or cases under observation only are acceptable).
(6) Patients with a history of convulsive disorders such as epilepsy.
(7) Patients with mental disorders or psychiatric symptoms who are deemed unable to participate in the clinical trial.
(8) Female patients who are pregnant, breastfeeding, or wish to become pregnant, or male patients who wish to get their partners pregnant; patients with no intentions of contraception
(9) Patients who are judged to be inappropriate for participation in this trial by the investigator

Related Information

• Primary Sponsor: Ohde Yasuhisa
• Source(s) of Monetary Support: Meiji Seika Pharma Co.,Ltd.