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

Cancer-related Fatigue Clinical Trial

Official title:

PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314805
• Other study ID #: PH-CP026
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2018
• Est. completion date: August 27, 2021

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 27, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Neutropenia
• Neutropenia, Malignant

Intervention

Drug:
• Astragalus polysaccharides 500 mg
PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
• Placebo
500 ml saline, 3 days via i.v. infusion per chemotherapy cycle

Procedure:
• EC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Kaohsiung Branch	Kaohsiung City
Taiwan	E-Da Cancer Hospital	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital, Lakeview Branch	Keelung
Taiwan	Chang Gung Memorial Hospital, Taipei Branch	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in chemotherapy-related fatigue by brief fatigue Inventory		through 4 chemotherapy cycles (each cycle is 21 days)
Primary	Incidence of Grade 3/4 neutropenia		through 4 chemotherapy cycles (each cycle is 21 days)
Secondary	Incidence of other Grade 3/4 Hematologic Toxicities		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Secondary	Chemotherapy Dose Reductions		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Secondary	Days of chemotherapy delay		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Secondary	Cumulative Doses of G-CSF consumption		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Secondary	Health-related Quality of Life by EORTC QLQ-C30 & Br23		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Secondary	ECOG		through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)