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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440227 on ClinicalTrials.gov