PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
Status:
Completed
Trial end date:
2008-04-01
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 PG2 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 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.
* BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered
questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of
fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10
numeric rating scale (10 being the most unfavorable response). The single construct of the
BFI allows for the mean of the nine items to be the overall score. The score is categorized
as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that
correlates highly with similar fatigue and performance status measures.