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

P

PhytoHealth

Status and phase

Completed
Phase 2

Conditions

Cancer-related Fatigue
Neutropenia, Malignant

Treatments

Drug: Placebo
Drug: Astragalus polysaccharides 500 mg
Procedure: EC Chemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03314805
PH-CP026

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

Female

Ages

20+ years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

67 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Placebo
Treatment:
Procedure: EC Chemotherapy
Drug: Placebo
Treatment
Experimental group
Description:
Astragalus polysaccharides 500 mg
Treatment:
Procedure: EC Chemotherapy
Drug: Astragalus polysaccharides 500 mg

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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