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PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

NCT03314805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-06-04

No results posted yet for this study

Summary

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.

Conditions

  • Cancer-related Fatigue
  • Neutropenia, Malignant

Interventions

DRUG

Astragalus polysaccharides 500 mg

PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle

DRUG

Placebo

500 ml saline, 3 days via i.v. infusion per chemotherapy cycle

PROCEDURE

EC Chemotherapy

Epirubicin plus Cyclophosphamide every 21 days

Sponsors & Collaborators

  • PhytoHealth Corporation

    lead INDUSTRY

Principal Investigators

  • Kun-Ming Rau, MD · E-Da Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-05-26
Completion
2021-08-27

Countries

  • Taiwan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314805 on ClinicalTrials.gov