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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-08-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer-related Fatigue Neutropenia, Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

EC Chemotherapy

Intervention Type PROCEDURE

Epirubicin plus Cyclophosphamide every 21 days

Treatment

Astragalus polysaccharides 500 mg

Group Type EXPERIMENTAL

Astragalus polysaccharides 500 mg

Intervention Type DRUG

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

EC Chemotherapy

Intervention Type PROCEDURE

Epirubicin plus Cyclophosphamide every 21 days

Interventions

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Astragalus polysaccharides 500 mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

EC Chemotherapy

Epirubicin plus Cyclophosphamide every 21 days

Intervention Type PROCEDURE

Other Intervention Names

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PG2 Lyo. Injection 500 mg

Eligibility Criteria

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Inclusion Criteria

* Women who are able to provide informed consent
* Age 20 years and older
* Diagnosis of stage II to III breast cancer
* Patients who had undergone surgery for breast cancer treatment.
* Planning to receive anthracycline -based adjuvant chemotherapy
* Have adequate bone marrow, liver, and renal function
* ECOG ≦1
* Willing and able to complete quality of life questionnaires.

Exclusion Criteria

* Pregnancy or lactating women.
* Baseline BFI score \>3.
* History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
* History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
* Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No