RecruitingPhase 2NCT05440227

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

A Phase II, Double Blind, Randomized, Placebo-controlled Study of PG2 Injection for the Treatment of moderate-to Severe Fatigue in Patients With Locally Advanced, Recurrent, or Metastatic Breast Cancer Who Are Receiving Infusional Chemotherapy


Sponsor

PhytoHealth Corporation

Enrollment

36 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing PG2, an herbal injection made from Astragalus, to see if it can reduce moderate to severe tiredness (fatigue) in women with breast cancer who are receiving chemotherapy through an IV. **You may be eligible if...** - You are a woman aged 20 or older - You have locally advanced, recurrent, or metastatic breast cancer and are currently on IV chemotherapy - You have been experiencing moderate to severe cancer-related fatigue (rated 4 or above on a 0-10 scale on at least two occasions, at least 14 days apart) - Your blood counts and organ function are within acceptable ranges - Your pain is adequately controlled (4 or below on a 0-10 scale) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have brain metastases or a primary brain tumor - You have a psychiatric condition or substance abuse disorder - You are currently pregnant or breastfeeding - You are using opioid pain medications - You have a known allergy to Astragalus products - You are taking medications for alcohol use disorder or herbal/dietary supplements marketed for energy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPG2 Lyo. Injection 500mg

PG2 Lyo. Injection 500mg (reconstituted with 0.9% normal saline 500ml) will be administered weekly for 8 weeks.

DRUGPlacebo 0.9% normal saline

0.9% normal saline 500ml will be administered weekly for 8 weeks.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05440227


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