Clincosm LogoSign in Get a demo

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

Sponsor
PhytoHealth Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03314805
Collaborator
(none)
67
Enrollment
5
Locations
2
Arms
41.9
Actual Duration (Months)
13.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Astragalus polysaccharides 500 mg
  • Drug: Placebo
  • Procedure: EC Chemotherapy
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
Aug 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Placebo

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

Procedure: EC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days
Experimental: Treatment

Astragalus polysaccharides 500 mg

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

    • Procedure: EC Chemotherapy
    Epirubicin plus Cyclophosphamide every 21 days

    Outcome Measures

    Primary Outcome Measures

    1. Change in chemotherapy-related fatigue by brief fatigue Inventory [through 4 chemotherapy cycles (each cycle is 21 days)]

    2. Incidence of Grade 3/4 neutropenia [through 4 chemotherapy cycles (each cycle is 21 days)]

    Secondary Outcome Measures

    1. Incidence of other Grade 3/4 Hematologic Toxicities [through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)]

    2. Chemotherapy Dose Reductions [through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)]

    3. Days of chemotherapy delay [through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)]

    4. Cumulative Doses of G-CSF consumption [through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)]

    5. Health-related Quality of Life by EORTC QLQ-C30 & Br23 [through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 E-Da Cancer Hospital Kaohsiung City Taiwan 824
    2 Chang Gung Memorial Hospital, Kaohsiung Branch Kaohsiung City Taiwan 833
    3 Chang Gung Memorial Hospital, Lakeview Branch Keelung City Taiwan 204
    4 Chang Gung Memorial Hospital, Taipei Branch Taipei Taiwan 105
    5 Chang Gung Memorial Hospital, Linkou Branch Taoyuan Taiwan 333

    Sponsors and Collaborators

    • PhytoHealth Corporation

    Investigators

    • Principal Investigator: Kun-Ming Rau, MD, E-Da Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PhytoHealth Corporation
    ClinicalTrials.gov Identifier:
    NCT03314805
    Other Study ID Numbers:
    • PH-CP026
    First Posted:
    Oct 19, 2017
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PhytoHealth Corporation
    astragalus polysaccharides
    breast cancer
    adjuvant chemotherapy
    Additional relevant MeSH terms:
    Neutropenia

    Study Results

    No Results Posted as of Jun 15, 2022