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

PhytoHealth

Status and phase

Completed

Phase 4

Conditions

Cancer-related Fatigue

Treatments

Drug: Astragalus Polysaccharides 250 mg

Drug: Astragalus Polysaccharides 500 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01720550

PH-CP012 (II)

Details and patient eligibility

About

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.

Full 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.

Enrollment

323 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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