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

Primary Purpose

Cancer-related Fatigue, Neutropenia, Malignant

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Astragalus polysaccharides 500 mg

Placebo

EC Chemotherapy

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring astragalus polysaccharides, breast cancer, adjuvant chemotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

E-Da Cancer Hospital
Chang Gung Memorial Hospital, Kaohsiung Branch
Chang Gung Memorial Hospital, Lakeview Branch
Chang Gung Memorial Hospital, Taipei Branch
Chang Gung Memorial Hospital, Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Placebo

Astragalus polysaccharides 500 mg

Outcomes

Primary Outcome Measures

Change in chemotherapy-related fatigue by brief fatigue Inventory

Incidence of Grade 3/4 neutropenia

Secondary Outcome Measures

Incidence of other Grade 3/4 Hematologic Toxicities

Chemotherapy Dose Reductions

Days of chemotherapy delay

Cumulative Doses of G-CSF consumption

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

ECOG

Full Information

NCT ID

NCT03314805

First Posted

September 26, 2017

Last Updated

March 27, 2023

Sponsor

PhytoHealth Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03314805

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

May 26, 2021 (Actual)

Study Completion Date

August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PhytoHealth Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Fatigue, Neutropenia, Malignant

Keywords

astragalus polysaccharides, breast cancer, adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Astragalus polysaccharides 500 mg

Intervention Type

Drug

Intervention Name(s)

Astragalus polysaccharides 500 mg

Other Intervention Name(s)

PG2 Lyo. Injection 500 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

EC Chemotherapy

Intervention Description

Epirubicin plus Cyclophosphamide every 21 days

Primary Outcome Measure Information:

Title

Change in chemotherapy-related fatigue by brief fatigue Inventory

Time Frame

through 4 chemotherapy cycles (each cycle is 21 days)

Title

Incidence of Grade 3/4 neutropenia

Time Frame

through 4 chemotherapy cycles (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Incidence of other Grade 3/4 Hematologic Toxicities

Time Frame