Symptoms and General Pathology

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Syndrome

Fatigue

Herbal and Botanical

All Drugs and Chemicals

Astragalus

PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)

PG2 (250 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)

PG2 Injection 500 mg PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)

Astragalus Polysaccharides 500 mg

PG2 Injection 250 mg PG2 (250 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)

Astragalus Polysaccharides 250 mg

Lin C Chin, PhD., RN

This study is for an "add-on" study to the "main" study (Protocol No.: PH-CP012). The information of patients from main study will be collected by questionnaire survey and actigraphy measurement to evaluate the relationship between fatigue, depression and sleep disorder and the efficacy of PG2 after treatment.The association between symptom cluster and circadian rhythm will be also further explored.

The study is "PG2 Treatment for Improving Fatigue among Advanced Cancer Patients under Standard Palliative Care" (Protocol Number: PH-CP012) of the additional plan, through questionnaires and using actigraphy measuring circadian rhythm collect patient data master plans, assessed for "PG2" treatment of cancer patients before and after treatment fatigue, depression, sleep disorders and other related symptoms of resistance and the effectiveness of treatment, and to further explore the symptom clusters in cancer patients associated with the circadian rhythm

Effects of PG2 on Fatigue-Related Symptom Clusters

three measurements means:3 days prior to the first dose of study medication began wearing courses of the last visits to the first week; last treatment of 3rd and 7th weeks of medication visits began wearing last time between the 4th and 8th week of visits

Taipei Medical University

Dean

Neoplasms

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

PG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks)

Wen-Chien WC Huang, MD, PhD

The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.

The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.

The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.

It's randomized, open-label study. Locally advanced esophageal cancer patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The eligible patients will be randomized into one of two study arms: 1) the CCRT- PG2 arm; and 2) the CCRT alone arm. All eligible patients will receive the standard preoperative CCRT during study period and standard surgery 6 weeks after completion of radiation therapy.

The primary objective of this study is to evaluate the efficacy of PG2 concurrent with CCRT for relieving fatigue. Patient's fatigue status will be measured by the BFI-T.

The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Patients' quality of life will be assessed by the Functional Assessment of Cancer Therapy- General (FACT-G7 v.4). Patients' appetite will be assessed by VAS appetite score. The effect of PG2 on tumor response post CCRT, DFS and OS of patients will also be evaluated.

Peripheral blood samples and tumor biopsy samples will be collected from all subjects at screening period, during CCRT and post CCRT period to perform Immune biomarker assessment in the add-on study.

PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.

FACT-G7, a rapid version of the Functional Assessment of Cancer Therapy-General (FACT-G) which is one of most validated assessment tools to evaluate health related qulaity of life (HRQoL) among cancer patients. It is a 27-item instrument containing four subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB) on 0-4 scale with a recall period of the past 7 days. The scores of these items must be reversed, and then summed to a total, which is the subscale score. The higher score is presented as the better quality of life.

Visual Analog Score for appetite is a single-item scale will be used to measure by A 10-cm vertical line anchored with the number 0 to indicate "no appetite" and number 10 to indicate "worst possible appetite."

Disease free survival (DFS) is defined as the time from initiation to relapse or death, whichever occurred first.

Overall survival (OS) is defined as the time from initiation to death of any cause.

PhytoHealth Corporation

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Breast Neoplasms

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Epirubicin

PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle

Astragalus polysaccharides 500 mg

500 ml saline, 3 days via i.v. infusion per chemotherapy cycle

Placebo

Epirubicin plus Cyclophosphamide every 21 days

EC Chemotherapy

Kun-Ming Rau, MD

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of PG2 on Fatigue-Related Symptom Clusters	NCT02740959	Cancer-related ...	Astragalus Poly... Astragalus Poly...	20 Years -	Taipei Medical University
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer	NCT03611712	Cancer-related ... Survival Tumor, Esophage...	Astragalus Poly...	20 Years - 75 Years	PhytoHealth Corporation
PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy	NCT03314805	Cancer-related ... Neutropenia, Ma...	Astragalus poly... Placebo EC Chemotherapy	20 Years -	PhytoHealth Corporation
Effects of PG2 on Fatigue-Related Symptom Clusters	NCT02740959	Cancer-related ...	Astragalus Poly... Astragalus Poly...	20 Years -	Taipei Medical University
PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy	NCT03314805	Cancer-related ... Neutropenia, Ma...	Astragalus poly... Placebo EC Chemotherapy	20 Years -	PhytoHealth Corporation

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