ClinicalTrials.Veeva

Menu

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

T

Taiwan THL Co.Ltd.

Status and phase

Completed
Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Dietary Supplement: THL-P

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00976365
NTUH-REC No.2008100025M
THL-P

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

THL-P
Experimental group
Description:
Solution for study only.
Treatment:
Dietary Supplement: THL-P
Sugar pill
Placebo Comparator group
Description:
THL-p
Treatment:
Dietary Supplement: THL-P

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems