Ireland
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Recruiting Phase 2

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

NCT05440227 · tracked via the Priya Life Science Taiwan tracker
Sponsor
PhytoHealth Corporation
Phase
Phase 2
Started
2023-05-17
Last updated
2025-06-05

Condition(s) studied

Cancer-related Fatigue

Investigational drug(s) / intervention(s)

PG2 Lyo. Injection 500mgPlacebo 0.9% normal saline

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

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

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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Women aged ≥ 20 years 2. ECOG performance score ≤ 2 3. Locally advanced, recurrent or metastatic, histologically documented breast cancer who is currently undergoing infusional chemotherapy regimen. 4. Presence of moderate to severe cancer related fatigue prior to randomization as defined by at least two records of usual fatigue score ≥ 4 on the numeric scale (0 -10), which must be ≥ 14 days apart. 5. Laboratory values obtained prior to randomization: * Hgb ≥ 10 g/dL (patients must not be transfused ≤ 14 days to meet this criterion) * Creatinine ≤ 1.2 x ULN * AST (SGOT) or ALT (SGPT) ≤1.5 x ULN (or ≤5.0 x ULN for patients with liver metastases) 6. Pain under controlled of score ≤ 4 on the numeric scale (0 -10) 7. Life expectancy ≥ 3 months 8. Ability to complete patient questionnaires alone or with assistance. 9. Negative pregnancy test done ≤ 14 days prior to randomization, for women of childbearing potential only, and willing to take efficient contraceptives procedures to avoid pregnancy throughout the study period. 10. Willing to provide written informed consent and agree to follow the study requirements. Exclusion Criteria: 1. Known brain metastasis or primary CNS malignancy 2. Has known psychiatric or substance abuse disorders. 3. Malnutrition, active infection, uncontrolled thyroid disorder, uncontrollable hypertension or diabetes mellitus, significant pulmonary disease and cardiovascular disease. 4. Currently using any other pharmacologic agents. 5. Subject who is unwilling to receive transfusions when, at the investigator's discretion, it is required to control her anemia. 6. Other medical conditions that necessitate chronic systemic use of steroids (e.g. use of prednisolone \> 10 mg daily or equivalent steroids fore more than 2 weeks). 7. ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetics. 8. Pain requiring opioid pain medication, however, over the counter analgesics such as acetaminophen or ibuprofen are allowed. 9. Use of monoamine oxidase inhibitors (MAOI) (such as Moclobemide). 10. Planning to start or complete any type of cancer therapy during the 8 weeks course of the study, once randomized on the study. 11. Use of any over the counter herbal/dietary supplement marketed for fatigue or energy. 12. Known history of hypersensitivity to Astragalus products. 13. Currently participating another interventional study or planning to join one in the upcoming 8 weeks after randomization. 14. Currently breast feeding. 15. With any other serious disease considered by the investigator not in the condition to enter into the trial.

Primary outcome measure(s)

  • Prorated AUC for the global BFI score — 8 weeks
    The prorated AUC for the global BFI score (average scores of 9 items), usual fatigue (item2) and worst fatigue (item 3) will be compared between PG2 and the placebo arms at the end of the study.

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05440227 on ClinicalTrials.gov ↗ ← All trials in Taiwan