PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
NCT05440227 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-06-05
Summary
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
- Cancer-related Fatigue
Interventions
- DRUG
-
PG2 Lyo. Injection 500mg
PG2 Lyo. Injection 500mg (reconstituted with 0.9% normal saline 500ml) will be administered weekly for 8 weeks.
- DRUG
-
Placebo 0.9% normal saline
0.9% normal saline 500ml will be administered weekly for 8 weeks.
Sponsors & Collaborators
-
PhytoHealth Corporation
lead INDUSTRY
Principal Investigators
-
Wei-Wu Chen, MD · National Taiwan University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-17
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
Countries
- Taiwan
Study Locations
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