Actively Recruiting
A Phase II, Double Blind, Randomized, Placebo-controlled Study of PG2 Injection for Moderate-to-Severe Fatigue in Women With Locally Advanced, Recurrent, or Metastatic Breast Cancer Receiving Chemotherapy
Led by PhytoHealth Corporation · Updated on 2025-06-05
36
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of weekly PG2 injections as a complementary treatment for women with recurrent unresectable or metastatic breast cancer who experience moderate to severe fatigue while undergoing chemotherapy. This Phase II, randomized, placebo-controlled study aims to determine if PG2 can reduce fatigue compared to a placebo during an 8-week treatment period. The study also examines other factors such as quality of life, hematological changes, and safety profiles. Participants will be randomly assigned to receive either 500 mg of PG2 injection or a placebo injection once a week for 8 weeks. Both treatments are given alongside their ongoing infusional chemotherapy. The study uses a triple-blind design, meaning that participants, researchers, and those administering treatment do not know which group each participant is in. During the study, participants will complete fatigue assessments using the Brief Fatigue Inventory (BFI) to measure fatigue levels over time. Researchers will monitor fatigue improvement rates, self-reported changes, and lab values including blood tests. Safety and quality of life will also be evaluated. The total participation duration covers the 8-week treatment period, with ongoing monitoring of outcomes throughout this time.
CONDITIONS
Brief Title
PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 years or older
- ECOG performance score of 2 or less
- Diagnosed with locally advanced, recurrent, or metastatic breast cancer currently undergoing infusional chemotherapy
- Moderate to severe cancer-related fatigue with at least two fatigue scores of 4 or higher on a 0-10 scale recorded at least 14 days apart
- Laboratory values before enrollment: Hemoglobin 10 g/dL or higher without transfusion within 14 days; Creatinine less than or equal to 1.2 times upper limit of normal; AST or ALT less than or equal to 1.5 times upper limit of normal (or 5.0 times for patients with liver metastases)
- Pain controlled with a score of 4 or less on a 0-10 scale
- Life expectancy of 3 months or more
- Able to complete questionnaires alone or with help
- Negative pregnancy test within 14 days before enrollment for women of childbearing potential, and willing to use effective contraception during the study
- Willing to provide informed consent and follow study requirements
You will not qualify if you...
- Known brain metastasis or primary central nervous system malignancy
- Psychiatric or substance abuse disorders
- Malnutrition, active infection, uncontrolled thyroid disorder, uncontrolled hypertension or diabetes, significant lung or heart disease
- Currently using other pharmacologic agents
- Unwilling to receive transfusions if needed to control anemia
- Chronic systemic steroid use above 10 mg prednisolone daily or equivalent for more than 2 weeks
- Major surgery within 4 weeks before enrollment, including procedures requiring general anesthesia
- Pain requiring opioid medication (over-the-counter pain relief is allowed)
- Use of monoamine oxidase inhibitors (MAOI) like Moclobemide
- Planning to start or complete any cancer therapy during the 8-week study period
- Use of herbal or dietary supplements marketed for fatigue or energy
- Known allergy to Astragalus products
- Participation in another interventional study or planning to join one within 8 weeks after enrollment
- Currently breastfeeding
- Any serious disease that makes participation unsafe as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive weekly PG2 or placebo injections as a complementary treatment during their chemotherapy to reduce moderate to severe fatigue.
Weekly visits for 8 weeks
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
T
Tim Teng-Hsu Wang, PhD
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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