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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IIa Study of Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Dietary Supplement: THL-P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed breast cancer with clinical evidence. Life expectancy of at least 4 weeks. Exclusion Criteria: Any Uncontrolled infection. Lupus erythematosus. Malignant tumor.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THL-P<br>Solution for study only. | Dietary Supplement: THL-P<br>* 20ml/bottle, TID, 24weeks<br>* Other names: THL-P solution;|
| Placebo Comparator: Sugar pill<br>THL-p | Dietary Supplement: THL-P<br>* 20ml/bottle, TID, 24weeks<br>* Other names: THL-P solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL |  | 6 months measure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine |  | 6 months measure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer