Clinical trial NCT01720550: PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Official title: PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer-related Fatigue
Keywords: Cancer-related fatigue
Palliative Treatment
Astragalus polysaccharides
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 323
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Fatigue Improvement Response Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: The fatigue improvement response rate among patients within and between cycles (by BFI-T)
timeFrame: 8 weeks
measure: The fatigue improvement by multiple BFI-T score percentage change levels among patients between two study arms
timeFrame: 8 weeks
measure: The mean of patients' fatigue score change from baseline within and between cycles (by BFI-T)
timeFrame: 8 weeks
measure: 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)
timeFrame: 8 weeks
measure: Karnofsky performance score
timeFrame: 8 weeks
measure: The correlation between Weight change and the related blood c-reactive protein level
timeFrame: 8 weeks
measure: Physical Examination
timeFrame: 8 weeks
measure: Labolatory Safety Examination
timeFrame: 8 weeks
measure: Incidence of Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
measure: Vital signs
timeFrame: 8 weeks
measure: Immune Biomarkers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Branch
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Lovers Lake Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Loiuying Campus
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University -Shung Ho Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Mackay Memorial Hospital
name: Yuen-Liang YL Lai, MD
role: PRINCIPAL_INVESTIGATOR
References: