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

Phase 2

Completed

• Conditions: Neutropenia, Malignant; Cancer-related Fatigue
• Interventions: Drug: Placebo; Drug: Astragalus polysaccharides 500 mg; Procedure: EC Chemotherapy

• Registration Number: NCT03314805
• Lead Sponsor: PhytoHealth Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-19
• Study Start: 2018-03-01
• Primary Completion: 2021-05-26
• Study Completion: 2021-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo
Control	EC Chemotherapy	Placebo
Treatment	Astragalus polysaccharides 500 mg	Astragalus polysaccharides 500 mg
Treatment	EC Chemotherapy	Astragalus polysaccharides 500 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Days of chemotherapy delay	through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
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)
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)
ECOG	through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

Trial Locations

Locations (5)

Chang Gung Memorial Hospital, Lovers Lake branch; 🇨🇳 Keelung, Taiwan

E-Da Cancer Hospital; 🇨🇳 Kaohsiung City, Taiwan

Chang Gung Memorial Hospital, Kaohsiung Branch; 🇨🇳 Kaohsiung City, Taiwan

Chang Gung Memorial Hospital, Taipei Branch; 🇨🇳 Taipei City, Taiwan

Chang Gung Memorial Hospital, Linkou Branch; 🇨🇳 Taoyuan City, Taiwan