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

January 9, 2024 updated by: Huang Ping, Zhejiang Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhanhong Chen
  • Phone Number: +8613606505124
  • Email: czred@sina.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Ping Huang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive component HER2 immunohistochemical IHC+++or IHC++confirmed to be HER2 positive by fluorescence in situ hybridization
  2. Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or epirubicin, C is cyclophosphamide, T is paclitaxel, liposome paclitaxel, albumin bound paclitaxel or docetaxel, H is trastuzumab, which can be combined with pertuzumab (P))，and before using anthracycline drugs, the left ventricular ejection fraction (LVEF) should be ≥ 50%
  3. Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment；
  4. ECOG PS: 0-1 points；
  5. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study, and sign a written informed consent form.

Exclusion Criteria:

  1. The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II)
  2. Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc
  3. There are contraindications or intolerance to treatment with trastuzumab, including allergies to trastuzumab, and the presence of underlying heart diseases that cannot be treated with trastuzumab as determined by a specialist
  4. Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
  5. Unable to cooperate with treatment and follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Provide preventive treatment with Shengmai San
Drug: Shengmai 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.
No Intervention: control group
No preventive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of cardiotoxicity in the treatment group and control group
Time Frame: From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.
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.
From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events in the treatment group and control group, except for cardiotoxicity
Time Frame: From the use of anthracycline drugs or Shengmai San to 1.5 years after the start of trastuzumab treatment.
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.
From the use of anthracycline drugs or Shengmai San to 1.5 years after the start of trastuzumab treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Ping Huang, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZCHBC025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Can apply to researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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