Status:
UNKNOWN
Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents
Lead Sponsor:
Fudan University
Conditions:
Chemotherapy-induced Nausea and Vomiting (CINV)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
At present, the clinical studies of 5-HT3RA are aimed at nausea and vomiting induced by single-day chemotherapy, but there are many chemotherapy schemes that require multi-day administration in clinic...
Detailed Description
Chemotherapy-induced nausea and vomiting (CINV) are commonly occurring, which have a negative impact on patient's quality of life and lead to poor compliance with further chemotherapy. In addition, na...
Eligibility Criteria
Inclusion
- Female aged ≥ 18 years;
- Histologically and/or cytologically confirmed locally advanced/metastatic breast cancer;
- The physical status score ECOG ≤ 2；
- Life expectancy of ≥3 months;
- Will receive the first treatment cycle of oral pirotinib combined with capecitabine;
- In accordance with the indication of chemotherapy and basic requirements;
- Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L；platelet count ≥80×109/L
- Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)
- Other important organs function normally
- Subjects voluntarily participate and signed the informed consent form.
Exclusion
- Contraindicated to 5-HT receptor antagonists (such as gastrointestinal obstruction) or allergy to 5-HT;
- Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
- Liver and kidney diseases, infections, and diseases of central nervous system or mental health. Patients who are evaluated by investigators as unsuitable for inclusion;
- Prolonged QT interval at baseline (QTc\>470msec at baseline);
- Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
- Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;
- Patens unable to cooperate and describe treatment response;
- History of drug abuse and alcohol dependence;
- Pregnancy, lactation or intended pregnancy;
- History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®
- Those who have participated or plan to participate in other clinical trials of granisetron; those who have participated in other clinical trials within 30 days before enrollment;
- Unable to eat for any reason;
- Other situations evaluated by investigators as unsuitable for enrollment.
Key Trial Info
Start Date :
July 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04472143
Start Date
July 18 2020
End Date
December 31 2022
Last Update
April 20 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032