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

Primary Purpose

Cancer-related Fatigue

Status

Recruiting

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

PG2 Lyo. Injection 500mg

Placebo 0.9% normal saline

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring breast cancer, fatigue, CRF

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PG2 treatment group

Placebo-controlled group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fatigue improvement response rate (FIRR)

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.

Full Information

NCT ID

NCT05440227

First Posted

June 27, 2022

Last Updated

June 27, 2022

Sponsor

PhytoHealth Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05440227

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2022 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PhytoHealth Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Fatigue

Keywords

breast cancer, fatigue, CRF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PG2 treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo-controlled group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PG2 Lyo. Injection 500mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo 0.9% normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Prorated AUC for the global BFI score

Description

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.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Fatigue improvement response rate (FIRR)

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tim Teng-Hsu Wang, PhD

Phone

+886 2 2545-3697

Ext

2317

tim.wang@phytohealth.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-Wu Chen, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei-Wu Chen, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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