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Completed

NCT Number: NCT00976365

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

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).

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National Taiwan University Hospital

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

THL-P

Dietary Supplement

20ml/bottle, TID, 24weeks

Other names: THL-P solution

Primary outcomes

  1. QOL

    Time frame: 6 months measure

Secondary outcomes

  1. CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine

    Time frame: 6 months measure

Sponsors and collaborators

Lead sponsor

Taiwan THL Co.LTd.

Industry

Collaborators

  • National Taiwan University Hospital

Registry information

Official study title

Phase IIa Study of Metastatic Breast Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2009
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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