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

Cancer-related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720550
• Other study ID #: PH-CP012 (II)
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

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)
• 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)

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang Gung Memorial Hospital, Kaohsiung Branch	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital, Lakeview Branch	Keelung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chi Mei Hospital, Loiuying Campus	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Taipei Medical University -Shung Ho Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Improvement Response Rate	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).	4 weeks
Secondary	The fatigue improvement response rate among patients within and between cycles (by BFI-T)		8 weeks
Secondary	The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms		8 weeks
Secondary	The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)		8 weeks
Secondary	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)		8 weeks
Secondary	Karnofsky performance score		8 weeks
Secondary	The correlation between Weight change and the related blood c-reactive protein level		8 weeks
Secondary	Physical Examination		8 weeks
Secondary	Labolatory Safety Examination	Included hematological, biochemical and urine examination	8 weeks
Secondary	Incidence of Adverse Events as a Measure of Safety and Tolerability		8 weeks
Secondary	Vital signs		8 weeks
Secondary	Immune Biomarkers	This outcome specified for academic research was designed in add-on protocol (only submitted to IRB)	8 weeks