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

Primary Purpose

Breast Cancer, Bone Metastasis

Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
Chinese Herbs
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Breast Cancer focused on measuring breast cancer, bone metastasis, traditional Chinese medicine(TCM)

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)Female

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2013
    Last Updated
    December 10, 2013
    Sponsor
    Shanghai University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02011880
    Brief Title
    Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
    Official Title
    Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Temporarily not available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai University of Traditional Chinese Medicine

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Bone Metastasis
    Keywords
    breast cancer, bone metastasis, traditional Chinese medicine(TCM)

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Chinese Herbs
    Other Intervention Name(s)
    Fructus Cnidii, Psoralea Corylifolin L., monkhsood, Breast Cancer Postoperative Prescription
    Intervention Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Eligibility 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.

    12. IPD Sharing Statement

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

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