Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Dietary Supplement: THL-P

• Registration Number: NCT00976365
• Lead Sponsor: Taiwan THL Co.LTd.

Brief Summary

The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).

Detailed Description

The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.

The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.

Study Timeline

• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Study Start: 2009-10
• Primary Completion: 2011-01
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Confirmed breast cancer with clinical evidence.
• Life expectancy of at least 4 weeks.

Exclusion Criteria

• Any Uncontrolled infection.
• Lupus erythematosus.
• Malignant tumor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	THL-P	THL-p
THL-P	THL-P	Solution for study only.

Primary Outcome Measures

Name	Time	Method
QOL	6 months measure

Secondary Outcome Measures

Name	Time	Method
CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine	6 months measure

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei city, Taiwan