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Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer

Expanded access is temporarily not available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011880
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
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.
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
December 10, 2013
December 13, 2013
December 13, 2013
 
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
The purpose of this clinical research study is to learn if the clinical effects of combined Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OBJECTIVES:

  • Evaluate the effect of the Chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis.
  • Evaluate the effect of the Chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OUTLINE: This is a randomized,multicentric, placebo-controlled, double-blind study. Patients are dynamic randomized to one of two treatment arms.

  • Arm I:Patients receive traditional Chinese medicine(trial drugs) and endocrine therapy for 3 months.
  • Arm II:Patients receive placebo and endocrine therapy for 3 months. All patients will be followed up for another 3 months with the trial drugs and endocrine therapy.

According to the sample size estimate:There are 296 patients (148 per treatment arm)will be collected in this trial.

Expanded Access
Dietary Supplement: Chinese Herbs

Dietary Supplement:Experiment group:

Fructus Cnidii,Psoralea Corylifolin L.,monkshood

-Granules,Oral(add into the breast cancer postoperative prescription solution),A Pack(Fructus Cnidii 9g,Psoralea Corylifolin L. 15g,monkshood 9g),Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity

Breast Cancer Postoperative Prescription

-Water Decoction,Oral,200ml,Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity

Dietary Supplement:Contrast Group:

Breast Cancer Postoperative Prescription

-Water Decoction,Oral,200ml,Bid Days,3 Periods( a month is a period),Until progression/unacceptable toxicity

Other Names:
  • Fructus Cnidii
  • Psoralea Corylifolin L.
  • monkhsood
  • Breast Cancer Postoperative Prescription
Not Provided
 
Temporarily not available
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02011880
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Not Provided
Not Provided
Shanghai University of Traditional Chinese Medicine
September 2013