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

This study has been completed.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Taiwan THL Co.LTd.
ClinicalTrials.gov Identifier:
NCT00976365
First received: July 6, 2009
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
THL-p
 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013