Granisetron Transdermal Patch System for Prevention of CINV by CapeOX

NCT05325190 | Unknown Phase 2

• 1 other identifier: E20210665A
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete control rate of delayed nausea and vomiting

  Complete control rate of delayed nausea and vomiting (CC, 24 hours to 20 days before the first day of chemotherapy)

  24 hours to 20 days before the first day of chemotherapy

Secondary Outcomes (5)

• Dates of delayed complete control

  from 24 hours to the 20th day of chemotherapy

• Complete control rate of acute nausea and vomiting

  24 hours to 20 days before the first day of chemotherapy

• Proportion of subjects receiving remedial treatment

  24 hours to 20 days before the first day of chemotherapy

• Changes of FLIE score before and after treatment

  24 hours to 20 days before the first day of chemotherapy

• Changes of hospital anxiety and Depression Scale (HAD) scores before and after treatment

  24 hours to 20 days before the first day of chemotherapy

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by NCI CTC AE V5.0.

  24 hours to 20 days before the first day of chemotherapy

Study Arms (1)

Intervention group

EXPERIMENTAL

Granisetron transdermal patch 3.1mg was given 48 hours before the first day of chemotherapy, Dexamethasone 12mg was taken orally on the first day of chemotherapy and dexamethasone 8mg was taken orally on the second and third days of chemotherapy,3.1mg granisetron transdermal patch was replaced on the 5th day of chemotherapy. Granisetron transdermal patch was removed and discarded on the 12th day of chemotherapy.

Drug: Granisetron Transdermal Patch System

Interventions

Granisetron Transdermal Patch System DRUG

Granisetron transdermal patch 3.1mg was given 48 hours before the first day of chemotherapy, Dexamethasone 12mg was taken orally on the first day of chemotherapy and dexamethasone 8mg was taken orally on the second and third days of chemotherapy,3.1mg granisetron transdermal patch was replaced on the 5th day of chemotherapy. Granisetron transdermal patch was removed and discarded on the 12th day of chemotherapy.

Also known as: Sancuso®

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• Wang C, Jiang Z, Zhang J, Zhuang Y, Sun L, Zhang J, Quan M, Lan L, Li Y, Wang B, Pan Z, Yan Z. Prolonged administration of the granisetron transdermal delivery system reduces capecitabine plus oxaliplatin regimen induced nausea and vomiting. BMC Cancer. 2024 Jul 18;24(1):867. doi: 10.1186/s12885-024-12616-9.

  PMID: 39026165 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cong Wang, Doctor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cong Wang, Doctor

CONTACT

+86 13752570372; wangcongalex@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Granisetron transdermal patch for the prevention and treatment of CINV

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 13, 2022
• Study Start: October 10, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)