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

NCT03314805 | Completed Phase 2

• 1 other identifier: PH-CP026
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

astragalus polysaccharides; breast cancer; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

• Change in chemotherapy-related fatigue by brief fatigue Inventory

  through 4 chemotherapy cycles (each cycle is 21 days)

• Incidence of Grade 3/4 neutropenia

  through 4 chemotherapy cycles (each cycle is 21 days)

Secondary Outcomes (6)

• Incidence of other Grade 3/4 Hematologic Toxicities

  through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

• Chemotherapy Dose Reductions

  through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

• Days of chemotherapy delay

  through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

• Cumulative Doses of G-CSF consumption

  through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

• Health-related Quality of Life by EORTC QLQ-C30 & Br23

  through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Procedure: EC Chemotherapy

Treatment

EXPERIMENTAL

Astragalus polysaccharides 500 mg

Drug: Astragalus polysaccharides 500 mg; Procedure: EC Chemotherapy

Interventions

Astragalus polysaccharides 500 mg DRUG

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

Also known as: PG2 Lyo. Injection 500 mg

Treatment

Placebo DRUG

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

Control

EC Chemotherapy PROCEDURE

Epirubicin plus Cyclophosphamide every 21 days

Control; Treatment

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (5)

E-Da Cancer Hospital

Kaohsiung City, 824, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

Chang Gung Memorial Hospital, Lovers Lake branch

Keelung, 204, Taiwan

Location

Chang Gung Memorial Hospital, Taipei Branch

Taipei, 105, Taiwan

Location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Shen WC, Chen SC, Wang CH, Hung CM, Peng MT, Liu CT, Chang YS, Kuo WL, Chou HH, Yeh KY, Wu TH, Wu CF, Chang PH, Huang YM, Yu CC, Lee CH, Rau KM. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer. Sci Rep. 2024 Oct 28;14(1):25690. doi: 10.1038/s41598-024-76627-z.

  PMID: 39465324 DERIVED

MeSH Terms

Conditions

Acquired agranulocytosis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kun-Ming Rau, MD

  E-Da Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 19, 2017
• Study Start: March 1, 2018
• Primary Completion: May 26, 2021
• Study Completion: August 27, 2021
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)