NCT00976365

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

July 6, 2009

Last Update Submit

June 8, 2011

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • QOL

    6 months measure

Secondary Outcomes (1)

  • CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine

    6 months measure

Study Arms (2)

THL-P

EXPERIMENTAL

Solution for study only.

Dietary Supplement: THL-P

Sugar pill

PLACEBO COMPARATOR

THL-p

Dietary Supplement: THL-P

Interventions

THL-PDIETARY_SUPPLEMENT

20ml/bottle, TID, 24weeks

Also known as: THL-P solution
Sugar pillTHL-P

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • King-Jen Chang, M.D.,Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2009

First Posted

September 14, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations

TW(1)