The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe fatigue while receiving chemotherapies.
The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe fatigue while receiving chemotherapies. The primary endpoint is to examine whether PG2, compar ed with placebo, can successfully reduce patients' fatigue (observed via prorated area under the curve \[AUC\] for the Brief Fatigue Inventory \[BFI\] scores) when primed with PG2 for 8 weeks during their chemotherapy. The other efficacy endpoints including th e time course change of patient reported BFI, fatigue improvement response rate (fatigue improvement response is defined as those with at least 10% reduction from baseline in the total BFI scores) after 8 weeks, self perceived improvement, hematological improvement, health related quality of life, and safety profiles will also be assessed between treatment arms and compared with the baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
PG2 Lyo. Injection 500mg (reconstituted with 0.9% normal saline 500ml) will be administered weekly for 8 weeks.
0.9% normal saline 500ml will be administered weekly for 8 weeks.
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGProrated AUC for the global BFI score
The prorated AUC for the global BFI score (average scores of 9 items), usual fatigue (item2) and worst fatigue (item 3) will be compared between PG2 and the placebo arms at the end of the study.
Time frame: 8 weeks
Fatigue improvement response rate (FIRR)
FIRR is defined as those with at least 10% reduction from baseline in the total BFI scores after 8-week treatment. 20% and 30% reduction will also be evaluated.
Time frame: 8 weeks
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