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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976365
First Posted: September 14, 2009
Last Update Posted: June 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Taiwan University Hospital
Information provided by:
Taiwan THL Co.LTd.
July 6, 2009
September 14, 2009
June 9, 2011
October 2009
January 2011   (Final data collection date for primary outcome measure)
QOL [ Time Frame: 6 months measure ]
Same as current
Complete list of historical versions of study NCT00976365 on ClinicalTrials.gov Archive Site
CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine [ Time Frame: 6 months measure ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
Phase IIa Study of 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).

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metastatic Breast Cancer
Dietary Supplement: THL-P
20ml/bottle, TID, 24weeks
Other Name: THL-P solution
  • Experimental: THL-P
    Solution for study only.
    Intervention: Dietary Supplement: THL-P
  • Placebo Comparator: Sugar pill
    THL-p
    Intervention: Dietary Supplement: THL-P
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any Uncontrolled infection.
  • Lupus erythematosus.
  • Malignant tumor.
Sexes Eligible for Study: Female
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00976365
THL-P
NTUH-REC No.2008100025M
Yes
Not Provided
Not Provided
King-Jen Chang, / Surgy, National Taiwan University Hospital
Taiwan THL Co.LTd.
National Taiwan University Hospital
Principal Investigator: King-Jen Chang, M.D.,Ph.D. National Taiwan University Hospital
Taiwan THL Co.LTd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP