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PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01720550
First received: October 29, 2012
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
The objective of this study is to conduct a trial in the spirit of providing as much as possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and safety of different doses of PG2 treatment for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available. Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients between two study arms will then be compared as the basis for efficacy evaluation at the end of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores change from baseline among patients within and between cycles will be included in the secondary efficacy endpoints, and will be compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from EORTC(European Organization) for Research and Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include Karnofsky performance scores, and weight change and its related c-reactive protein level of the patients.

Condition Intervention Phase
Cancer-related Fatigue Drug: Astragalus Polysaccharides 500 mg Drug: Astragalus Polysaccharides 250 mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • Fatigue Improvement Response Rate [ Time Frame: 4 weeks ]
    Patient's fatigue status will be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T). The fatigue improvement response rate among patients between two study arms will be compared as the basis for efficacy evaluation at the end of the first treatment cycle (4th week).


Secondary Outcome Measures:
  • The fatigue improvement response rate among patients within and between cycles (by BFI-T) [ Time Frame: 8 weeks ]
  • The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms [ Time Frame: 8 weeks ]
  • The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T) [ Time Frame: 8 weeks ]
  • Symptoms and Quality of Life Assessments: SS11 from EORTC QLQ-C30 (including the evaluation of the quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life) [ Time Frame: 8 weeks ]
  • Karnofsky performance score [ Time Frame: 8 weeks ]
  • The correlation between Weight change and the related blood c-reactive protein level [ Time Frame: 8 weeks ]
  • Physical Examination [ Time Frame: 8 weeks ]
  • Labolatory Safety Examination [ Time Frame: 8 weeks ]
    Included hematological, biochemical and urine examination

  • Incidence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
  • Vital signs [ Time Frame: 8 weeks ]
  • Immune Biomarkers [ Time Frame: 8 weeks ]
    This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)


Enrollment: 323
Actual Study Start Date: November 2012
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG2 High Dose
Astragalus Polysaccharides 500 mg
Drug: Astragalus Polysaccharides 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)
Other Name: PG2 Injection 500 mg
Experimental: PG2 Low Dose
Astragalus Polysaccharides 250 mg
Drug: Astragalus Polysaccharides 250 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)
Other Name: PG2 Injection 250 mg

Detailed Description:

This is a trial to evaluate use of different doses of PG2 treatment for fatigue improvement in advanced cancer patients who are under standard palliative care at hospice setting and have no further curative options available. Only 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. All patients will continue the standard palliative care (SPC) during this study.

The main aim of this trial is to compare improvement of patient's fatigue status between patients with different doses of PG2 treatment. Patient's fatigue status will be assessed by the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement response will be defined as an improvement in the mean fatigue scores by at least 10% from baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 High Dose arm; and 2) the PG2 Low Dose arm.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed the informed consent form
  • ≧ 20 years old
  • Have locally advanced or metastatic cancer or inoperable advanced cancer
  • Under standard palliative care (SPC) at hospice setting and have no further curative options available
  • BFI score ≧ 4
  • Life expectancy of at least 3 months as determined by the investigator
  • Willing and able to complete quality of life questionnaires

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Uncontrolled systemic disease
  • Take central nervous system stimulators within 30 days before screening
  • Have enrolled or have not yet completed other investigational drug trials within 30 days before screening
  • Karnofsky Performance Scores less than 30 %
  • Diagnosed as dying status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720550

Locations
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Kun-Ming Rau
Kaohsiung City, Taiwan, 83301
Chang Gung Memorial Hospital, Lakeview Branch
Keelung City, Taiwan, 204
China Medical University Hospital
Taichung, Taiwan, 404
Chi Mei Hospital, Loiuying Campus
Tainan, Taiwan, 736
Mackay Memorial Hospital
Taipei, Taiwan, 104
Tri-Service General Hospital
Taipei, Taiwan, 114
Taipei Medical University -Shung Ho Hospital
Taipei, Taiwan, 235
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Yuen-Liang YL Lai, MD Mackay Memorial Hospital
  More Information

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01720550     History of Changes
Other Study ID Numbers: PH-CP012 (II)
Study First Received: October 29, 2012
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by PhytoHealth Corporation:
Cancer-related fatigue
Palliative Treatment
Astragalus polysaccharides

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017