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

This study has been completed.
National Taiwan University Hospital
Information provided by:
Taiwan THL Co.LTd.
ClinicalTrials.gov Identifier:
First received: July 6, 2009
Last updated: June 8, 2011
Last verified: June 2011

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).

Condition Intervention Phase
Metastatic Breast Cancer
Dietary Supplement: THL-P
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIa Study of Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Taiwan THL Co.LTd.:

Primary Outcome Measures:
  • QOL [ Time Frame: 6 months measure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine [ Time Frame: 6 months measure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THL-P
Solution for study only.
Dietary Supplement: THL-P
20ml/bottle, TID, 24weeks
Other Name: THL-P solution
Placebo Comparator: Sugar pill
Dietary Supplement: THL-P
20ml/bottle, TID, 24weeks
Other Name: THL-P solution

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.


Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Any Uncontrolled infection.
  • Lupus erythematosus.
  • Malignant tumor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976365

National Taiwan University Hospital
Taipei city, Taiwan, 110
Sponsors and Collaborators
Taiwan THL Co.LTd.
National Taiwan University Hospital
Principal Investigator: King-Jen Chang, M.D.,Ph.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: King-Jen Chang, / Surgy, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00976365     History of Changes
Other Study ID Numbers: THL-P, NTUH-REC No.2008100025M
Study First Received: July 6, 2009
Last Updated: June 8, 2011
Health Authority: Taiwan: Department of Health
United States: Institutional Review Board

Keywords provided by Taiwan THL Co.LTd.:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 20, 2014