This study aims to explore the prevention of delayed chemotherapy induced by CAPOX regimen with granisetron transdermal patch。
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
57
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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplete 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)
Time frame: 24 hours to 20 days before the first day of chemotherapy
Dates of delayed complete control
Definition of DDCC (dates of delayed complete control): from 24 hours to the 20th day of chemotherapy, the patient has no vomiting, no rescue treatment, no nausea (VAS \< 5mm) or mild nausea (VAS \< 25mm, mild);
Time frame: from 24 hours to the 20th day of chemotherapy
Complete control rate of acute nausea and vomiting
From 0 hour to 24 hours after chemotherapy, the patients did not vomit or need rescue treatment, and there was no incidence of nausea (VAS \< 5mm) or mild nausea (VAS \< 25mm).
Time frame: 24 hours to 20 days before the first day of chemotherapy
Proportion of subjects receiving remedial treatment
The investigator evaluated the degree of nausea and vomiting reported by the patient and the observed clinical manifestations according to the study In the judgment of the patient, remedial treatment can be used only when necessary to treat nausea or vomiting, and remedial treatment shall not be used when the patient does not have such symptoms.
Time frame: 24 hours to 20 days before the first day of chemotherapy
Changes of FLIE score before and after treatment
FLIE includes 9 questions about nausea and 9 questions about vomiting. The answers to each item were marked according to the visual analog scale with a score of 7. The nausea score, vomiting score and total score were calculated by summing the answers of each category and the total answer. Considering the purpose of this scheme, "no impact" on daily life is defined as that the average item score is greater than 6 points (total score \> 108) according to 7 subscales.
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Time frame: 24 hours to 20 days before the first day of chemotherapy
Changes of hospital anxiety and Depression Scale (HAD) scores before and after treatment
HAD is mainly used for screening anxiety and depression of patients in general hospitals. There are 14 items in this scale, including 7 Depression was assessed in items (21 points in total), and anxiety was assessed in 7 items (21 points in total). The score of depression subscale is 0-7, indicating no symptoms; 8-10 points are suspicious of depressive symptoms, and 11-21 points must have depressive state. Anxiety subscale score 0-7 Asymptomatic; The anxiety symptoms are suspicious on 8-10 points, and there must be anxiety on 11-21 points.
Time frame: 24 hours to 20 days before the first day of chemotherapy