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

NCT01720550 | Completed Phase 4 DMC

• 1 other identifier: PH-CP012 (II)
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Cancer-related Fatigue

Keywords

Cancer-related fatigue; Palliative Treatment; Astragalus polysaccharides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The fatigue improvement response rate among patients within and between cycles (by BFI-T)

  8 weeks

• The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms

  8 weeks

• The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)

  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)

  8 weeks

• Karnofsky performance score

  8 weeks

Study Arms (2)

PG2 High Dose

EXPERIMENTAL

Astragalus Polysaccharides 500 mg

Drug: Astragalus Polysaccharides 500 mg

PG2 Low Dose

EXPERIMENTAL

Astragalus Polysaccharides 250 mg

Drug: Astragalus Polysaccharides 250 mg

Interventions

Astragalus Polysaccharides 500 mg DRUG

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)

Also known as: PG2 Injection 500 mg

PG2 High Dose

Astragalus Polysaccharides 250 mg DRUG

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)

Also known as: PG2 Injection 250 mg

PG2 Low Dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (9)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

Chang Gung Memorial Hospital, Lovers Lake Branch

Keelung, 204, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Chi Mei Hospital, Loiuying Campus

Tainan, 736, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Medical University -Shung Ho Hospital

Taipei, 235, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

Study Officials

• Yuen-Liang YL Lai, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (9)