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

NCT05440227 | Recruiting Phase 2

• 1 other identifier: PH-CP032
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer; fatigue; CRF

Outcome Measures

Primary Outcomes (1)

• Prorated AUC for the global BFI score

  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.

  8 weeks

Secondary Outcomes (1)

• Fatigue improvement response rate (FIRR)

  8 weeks

Study Arms (2)

PG2 treatment group

EXPERIMENTAL

500 mg PG2 injection will be administered to this group once per week for 8 weeks.

Drug: PG2 Lyo. Injection 500mg

Placebo-controlled group

EXPERIMENTAL

Placebo injection will be administered to this group once per week for 8 weeks.

Drug: Placebo 0.9% normal saline

Interventions

PG2 Lyo. Injection 500mg DRUG

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

PG2 treatment group

Placebo 0.9% normal saline DRUG

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

Placebo-controlled group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥ 20 years
• ECOG performance score ≤ 2
• Locally advanced, recurrent or metastatic, histologically documented breast cancer who is currently undergoing infusional chemotherapy regimen.
• 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.
• 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)
• Pain under controlled of score ≤ 4 on the numeric scale (0 -10)
• Life expectancy ≥ 3 months
• Ability to complete patient questionnaires alone or with assistance.
• 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.
• Willing to provide written informed consent and agree to follow the study requirements.

You may not qualify if:

• Known brain metastasis or primary CNS malignancy
• Has known psychiatric or substance abuse disorders.
• Malnutrition, active infection, uncontrolled thyroid disorder, uncontrollable hypertension or diabetes mellitus, significant pulmonary disease and cardiovascular disease.
• Currently using any other pharmacologic agents.
• Subject who is unwilling to receive transfusions when, at the investigator's discretion, it is required to control her anemia.
• 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).
• ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetics.
• Pain requiring opioid pain medication, however, over the counter analgesics such as acetaminophen or ibuprofen are allowed.
• Use of monoamine oxidase inhibitors (MAOI) (such as Moclobemide).
• Planning to start or complete any type of cancer therapy during the 8 weeks course of the study, once randomized on the study.
• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy.
• Known history of hypersensitivity to Astragalus products.
• Currently participating another interventional study or planning to join one in the upcoming 8 weeks after randomization.
• Currently breast feeding.
• With any other serious disease considered by the investigator not in the condition to enter into the trial.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Wei-Wu Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Teng-Hsu Wang, PhD

CONTACT

+886 2 2545-3697; tim.wang@phytohealth.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: May 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)