RecruitingPhase 3NCT06214195

The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity

Clinical Study on the Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity


Sponsor

Zhejiang Cancer Hospital

Enrollment

276 participants

Start Date

Jan 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether Shengmai San — a traditional Chinese herbal formula — can protect the heart from damage caused by certain breast cancer treatments. Specifically, some chemotherapy drugs (anthracyclines) and the targeted therapy trastuzumab can reduce heart function over time. The study wants to see if this herbal medicine can prevent or reduce that cardiac side effect. **You may be eligible if...** - You have non-metastatic HER2-positive breast cancer (stages I to III) - You are planned to receive a chemotherapy regimen that includes anthracyclines followed by trastuzumab (with or without pertuzumab) - Your heart pumping function (ejection fraction) is at least 50% before starting chemotherapy - You are in good general health and able to follow the study plan **You may NOT be eligible if...** - You have heart disease classified as moderate or severe (NYHA Class II or above) - You have severe heart rhythm problems or other serious heart conditions - You are allergic to ginseng, Ophiopogon, or other ingredients in Shengmai San - There are medical reasons you cannot receive trastuzumab - You have conditions that would make the planned treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGShengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)

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.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06214195