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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03314805
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer-related Fatigue Neutropenia, Malignant Drug: Astragalus polysaccharides 500 mg Drug: Placebo Procedure: EC Chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : March 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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 Name: PG2 Lyo. Injection 500 mg

Procedure: EC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days




Primary Outcome Measures :
  1. Change in chemotherapy-related fatigue by brief fatigue Inventory [ Time Frame: through 4 chemotherapy cycles (each cycle is 21 days) ]
  2. Incidence of Grade 3/4 neutropenia [ Time Frame: through 4 chemotherapy cycles (each cycle is 21 days) ]

Secondary Outcome Measures :
  1. Incidence of other Grade 3/4 Hematologic Toxicities [ Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) ]
  2. Chemotherapy Dose Reductions [ Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) ]
  3. Days of chemotherapy delay [ Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) ]
  4. Cumulative Doses of G-CSF consumption [ Time Frame: 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 [ Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) ]
  6. ECOG [ Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314805


Contacts
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Contact: Hsiao-Chien Cheng 886-2-25453697 ext 2334 hccheng@phytohealth.com.tw

Locations
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Taiwan
E-Da Cancer Hospital Recruiting
Kaohsiung City, Taiwan, 824
Chang Gung Memorial Hospital, Kaohsiung Branch Recruiting
Kaohsiung City, Taiwan, 833
Chang Gung Memorial Hospital, Lakeview Branch Recruiting
Keelung City, Taiwan, 204
Chang Gung Memorial Hospital, Taipei Branch Recruiting
Taipei, Taiwan, 105
Chang Gung Memorial Hospital, Linkou Branch Recruiting
Taoyuan, Taiwan, 333
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
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Principal Investigator: Kun-Ming Rau, MD E-Da Cancer Hospital

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Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT03314805    
Other Study ID Numbers: PH-CP026
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neutropenia
Fatigue
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases