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

June 2, 2025 updated by: PhytoHealth Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. The primary endpoint is to examine whether PG2, compar ed with placebo, can successfully reduce patients' fatigue (observed via prorated area under the curve [AUC] for the Brief Fatigue Inventory [BFI] scores) when primed with PG2 for 8 weeks during their chemotherapy. The other efficacy endpoints including th e time course change of patient reported BFI, fatigue improvement response rate (fatigue improvement response is defined as those with at least 10% reduction from baseline in the total BFI scores) after 8 weeks, self perceived improvement, hematological improvement, health related quality of life, and safety profiles will also be assessed between treatment arms and compared with the baseline.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Wei-Wu Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PG2 treatment group
500 mg PG2 injection will be administered to this group once per week for 8 weeks.
Drug: PG2 Lyo. Injection 500mg
PG2 Lyo. Injection 500mg (reconstituted with 0.9% normal saline 500ml) will be administered weekly for 8 weeks.
Experimental: Placebo-controlled group
Placebo injection will be administered to this group once per week for 8 weeks.
Drug: Placebo 0.9% normal saline
0.9% normal saline 500ml will be administered weekly for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prorated AUC for the global BFI score
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue improvement response rate (FIRR)
Time Frame: 8 weeks
FIRR is defined as those with at least 10% reduction from baseline in the total BFI scores after 8-week treatment. 20% and 30% reduction will also be evaluated.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhytoHealth Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei-Wu Chen, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PH-CP032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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