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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
  Purpose
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.

Condition Intervention
Breast Cancer Bone Metastasis Dietary Supplement: Chinese Herbs

Study Type: Expanded Access     What is Expanded Access?
Official Title: Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Histologically confirmed breast cancer and hormone receptor positive.
  • Bone metastasis and have a measurable foci.
  • TCM syndrome type is deficiency of both vital energy and Yin ;maladjustment of ChongRen with deficiency Yang syndrome.
  • The Karnofsky score ≥60.
  • VAS score ≥3.
  • Expected survival at least 6 months or greater.
  • Age between 20 to 70(include 20 and 70).
  • The function of cardiovascular,hepar,renal and hematopoieses is relatively normal.

Exclusion Criteria:

  • Women during the pregnancy or breast feeding.
  • With a cardiovascular,hepar,renal,hematopoieses or other serious complications.
  • Be allergic to the trial drugs.
  • Participating in other trials.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02011880     History of Changes
Other Study ID Numbers: ZYSNXD-CC-ZDYJ043
First Submitted: December 10, 2013
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
Last Verified: September 2013

Keywords provided by Shanghai University of Traditional Chinese Medicine:
breast cancer
bone metastasis
traditional Chinese medicine(TCM)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Corylifolin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents