To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
This study is a randomized, controlled, open-label prospective clinical study. This study adopts an optimal design, with the main evaluation indicator being the incidence of cardiac toxicity. Patients who passed the inclusion and exclusion criteria through clinical research were randomly assigned to the experimental group and control group. Experimental(treatment)group: received preventive treatment with Shengmai Powder,and may also receive additional Chinese medicines based on the doctor's judgment and the patient's condition.Control group: during chemotherapy and trastuzumab administration, no Chinese medicine with ginseng, ophiopogon japonicus and schisandra chinensis as ingredients or western medicine with heart strengthening or heart protection function were used. During the treatment process, cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) are evaluated to determine the occurrence of cardiac toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
276
Ginseng 6g , Ophiopogon japonicus 12g ,Schisandra chinensis 5g , other secondary Chinese medicines can be added according to the doctor's judgment and the patient's condition,decoction in water, one dose and two decoctions, taken twice a day, continuously for 7 days from the start of each chemotherapy cycle (± 3 days), including anthracyclines and taxanes (the frequency and dosage of medication can be adjusted according to adverse reactions in the later stage); The total duration of medication interventionis 7 days per cycle, with a total of 8 cycles. If the chemotherapy is less than 8 cycles, continue taking for 7 consecutive days from the start of each subsequent trastuzumab cycle (the frequency and dosage can be adjusted based on adverse reactions) until a total of 8 cycles are reached.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe incidence of cardiotoxicity in the treatment group and control group
Calculate the incidence of cardiotoxicity associated with anthracycline sequential trastuzumab treatment of two groups.Cardiotoxicity is defined as the occurrence of symptomatic congestive heart failure, or a decrease in left ventricular ejection fraction (LVEF) without clinical symptoms that meets one of the following conditions: ① a decrease of ≥ 15% in LVEF from baseline after anti-cancer treatment; ② After anti-cancer treatment, LVEF decreased by ≥ 10% from baseline and the monitoring value was\<50%; ③ LVEF monitoring value after anti-cancer treatment is less than 45%. The definition of symptomatic congestive heart failure includes but is not limited to any one or more of the following: moist rales in the lungs, anterior tibial edema in both lower limbs, and cyanosis of the lips.
Time frame: From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.
The incidence of adverse events in the treatment group and control group, except for cardiotoxicity
Using the Common Terminology Criteria for Adverse Events (CTC AE) version 5.0, evaluate the adverse events and toxic reactions of the two groups, except for cardiotoxicity, to determine the incidence rate.
Time frame: From the use of anthracycline drugs or Shengmai San to 1.5 years after the start of trastuzumab treatment.
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