Clinical trial NCT05325190: Granisetron Transdermal Patch System for Prevention of CINV by CapeOX
Official title: Efficacy and Safety of Granisetron Transdermal Patch System for Prevention of Chemotherapy-induced Delayed Nausea and Vomiting by CapeOX：A Single-Arm, Open-Label, Phase II Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Granisetron transdermal patch for the prevention and treatment of CINV
Primary purpose: PREVENTION

Brief summary: This study aims to explore the prevention of delayed chemotherapy induced by CAPOX regimen with granisetron transdermal patch。

Detailed description: Chemotherapy induced nausea and vomiting (CINV) is one of the most common side effects of tumor chemotherapy. Anorexia occurs in mild cases, electrolyte and acid-base balance disorders and malnutrition even occur in severe cases. Some patients will also have anxiety, fear and depression, which seriously affect the quality of life. This study explored the efficacy and safety of granisetron transdermal patch in the prevention of delayed nausea and vomiting caused by capeox chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged \>18 years.
* Eligible patients were diagnosed with a colorectal malignancy and scheduled to receive chemotherapy of CapeOx regimens.
* The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores of patients were between 0 and 2.
* Patients with life expectancy≥6 months.
* Patients with the ability to understand the study and are willing to sign written informed consent document.
* Patients who were able to read, understand and follow the study procedures，and completed the questionnaire unaided.

Exclusion Criteria:

* Patients with metabolic and haematological abnormalities who are unsuitable for chemotherapy. The following criteria are included: (1) Abnormal of blood routine: absolute neutrophil count(ANC) \<1.5\*109/L，white blood cell count (WBC)\<3.0\*109/L, platelet count (PLT) \<100\*109/L or hemoglobin (HB)\<100g/L;(2) Abnormal liver function: aspartate aminotransaminase (AST) and/or aspartate aminotransferase (ALT)≥2.5\*ULN, bilirubin is greater than 1.5 times the upper limit of normal value (ULN). In patients with known liver metastasis: AST is greater than or equal to 5 times the upper limit of normal value (ULN); ALT is greater than or equal to 5 times the upper normal value (ULN); (3) Abnormal renal function: serum creatinine is greater than 1.5\*ULN.
* Patient had symptomatic primary or metastatic central nervous system malignancies.
* Patient used any drug with potential antiemetic effect within 7 days before receiving chemotherapy: 5-HT3 receptor antagonist (such as granisetron), phenothiazide (such as chlorpromazine), phenylbutanone (such as haloperidol), benzamide (such as metoclopramide), domperidone, cannabinoids, herbal medicine with potential antiemetic effect, anisodamine, seclizine, etc.
* Patients began to receive benzodiazepines or opioids within 48 hours before the first day of the study (except for single daily use of triazolam, temazepam or midazolam).
* Patients shall not receive any dose of systemic glucocorticoid treatment within 72 hours before the first day, except as specified in the protocol.
* Patients with historical or predisposing cardiac conduction abnormalities (such as torsade de pointe, ventricular tachycardia, long QT interval syndrome, or others), excluding incomplete right bundle branch block.
* Patients with severe cardiovascular diseases include acute myocardial infarction, unstable angina pectoris, significant membranous or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association \[NYHA\] class III-IV) and uncontrolled hypertension.
* Patients with severe emotional or mental disorders.
* Patients are taking or has used the following CYP3A4 inducers within 30 days before the first day of treatment, which will affect the efficacy of therapeutic drugs according to the evaluation of the researcher.
* Patients are taking or has used the following CYP3A4 substrates and inhibitors within 7 days before the first day of treatment, which will significantly increase the adverse events related to therapeutic drugs according to the evaluation of the investigator.
* Patients with active phase infection (e.g. pneumonia) or any uncontrolled disease (such as diabetic ketoacidosis or gastrointestinal obstruction), researchers believe that treatment may confuse research results or lead to uncertainty risk.
* Pregnant women, lactating women, or women of childbearing age with positive blood and/or urine HCG test results before the test. Male and female subjects did not take effective contraceptive measures, or planned to be pregnant within 6 months after the start of the trial.
* Patients have any medical history that the investigator believes may confound the results of the study or expose the patient to unnecessary risks.

Primary outcomes:
measure: Complete control rate of delayed nausea and vomiting
timeFrame: 24 hours to 20 days before the first day of chemotherapy
Secondary outcomes:
measure: Dates of delayed complete control
timeFrame: from 24 hours to the 20th day of chemotherapy
measure: Complete control rate of acute nausea and vomiting
timeFrame: 24 hours to 20 days before the first day of chemotherapy
measure: Proportion of subjects receiving remedial treatment
timeFrame: 24 hours to 20 days before the first day of chemotherapy
measure: Changes of FLIE score before and after treatment
timeFrame: 24 hours to 20 days before the first day of chemotherapy
measure: Changes of hospital anxiety and Depression Scale (HAD) scores before and after treatment
timeFrame: 24 hours to 20 days before the first day of chemotherapy
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by NCI CTC AE V5.0.
timeFrame: 24 hours to 20 days before the first day of chemotherapy
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Cong Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: