Actively Recruiting

Phase 2
Age: 20Years +
FEMALE
NCT05440227

PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients

Led by PhytoHealth Corporation · Updated on 2025-06-05

36

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe fatigue while receiving chemotherapies.

CONDITIONS

Official Title

PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients

Who Can Participate

Age: 20Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 60 years
  • ECOG performance score of 2 or less
  • Diagnosed with locally advanced, recurrent, or metastatic breast cancer and currently on infusional chemotherapy
  • Moderate to severe cancer-related fatigue defined by at least two fatigue scores of 4 or higher on a 0-10 scale at least 14 days apart
  • Hemoglobin level of 10 g/dL or higher without transfusion within 14 days
  • Creatinine level less than or equal to 1.2 times the upper limit of normal
  • AST or ALT less than or equal to 1.5 times the upper limit of normal (or 5 times if liver metastases present)
  • Pain score of 4 or less on a 0-10 scale
  • Life expectancy of 3 months or more
  • Ability to complete patient questionnaires alone or with help
  • Negative pregnancy test within 14 days prior to randomization for women of childbearing potential and agreement to use effective contraception
  • Willingness to provide informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Known brain metastasis or primary central nervous system malignancy
  • Known psychiatric or substance abuse disorders
  • Malnutrition, active infection, uncontrolled thyroid disorder, uncontrolled hypertension or diabetes, significant lung or heart disease
  • Current use of other pharmacologic agents
  • Unwillingness to receive transfusions when medically required
  • Chronic use of steroids over 10 mg prednisolone daily or equivalent for more than 2 weeks
  • Major surgery within 4 weeks before randomization
  • Pain requiring opioid medication (over-the-counter analgesics allowed)
  • Use of monoamine oxidase inhibitors (MAOI) such as Moclobemide
  • Planned start or completion of any cancer therapy during the 8-week study period after randomization
  • Use of herbal or dietary supplements marketed for fatigue or energy
  • Known allergy to Astragalus products
  • Participation in another interventional study or plan to join one within 8 weeks after randomization
  • Currently breastfeeding
  • Any other serious illness deemed unsuitable for trial participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

T

Tim Teng-Hsu Wang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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