Cancer-related Fatigue | PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Cancer-related Fatigue research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Astragalus Polysaccharides 500 mgPG2 (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)
Drug:Astragalus Polysaccharides 250 mgPG2 (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)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PG2 High DoseAstragalus Polysaccharides 500 mg
PG2 Low DoseAstragalus Polysaccharides 250 mg
Start Date: November 2012
Completed Date: June 2017
Phase: Phase 4
Primary Outcome: Fatigue Improvement Response Rate
Secondary Outcome: The fatigue improvement response rate among patients within and between cycles (by BFI-T)
Study sponsors, principal investigator, and references
Principal Investigator: Yuen-Liang YL Lai, MD
Lead Sponsor: PhytoHealth Corporation