PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
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.