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

Metastatic Breast Cancer Clinical Trial

Official title:

Phase IIa Study of Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976365
• Other study ID #: THL-P
• Secondary ID: NTUH-REC No.2008
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: June 8, 2011
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Taiwan THL Co.LTd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Dietary Supplement:
• THL-P
20ml/bottle, TID, 24weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei city

Sponsors (2)

Lead Sponsor	Collaborator
Taiwan THL Co.LTd.	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QOL		6 months measure	Yes
Secondary	CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine		6 months measure	Yes