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

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.
ClinicalTrials.gov Identifier: NCT00976365
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : June 9, 2011
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Taiwan THL Co.LTd.

Brief 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).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Dietary Supplement: THL-P Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIa Study of Metastatic Breast Cancer
Study Start Date : October 2009
Primary Completion Date : January 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: THL-P
Solution for study only.
Dietary Supplement: THL-P
20ml/bottle, TID, 24weeks
Other Name: THL-P solution
Placebo Comparator: Sugar pill
THL-p
Dietary Supplement: THL-P
20ml/bottle, TID, 24weeks
Other Name: THL-P solution



Primary Outcome Measures :
  1. QOL [ Time Frame: 6 months measure ]

Secondary Outcome Measures :
  1. CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine [ Time Frame: 6 months measure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976365


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

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
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

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

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