Spots Global Cancer Trial Database for PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients

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Trial Identification

Brief Title: PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients

Official Title: A Phase II, Double Blind, Randomized, Placebo-controlled Study of PG2 Injection for the Treatment of moderate-to Severe Fatigue in Patients With Locally Advanced, Recurrent, or Metastatic Breast Cancer Who Are Receiving Infusional Chemotherapy

Study ID: NCT05440227

Conditions

Cancer-related Fatigue

Interventions

PG2 Lyo. Injection 500mg

Placebo 0.9% normal saline

Study Description

Brief Summary: 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.

Detailed Description: 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.