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
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
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
NCT ID
NCT02011880
First Posted
December 10, 2013
Last Updated
December 10, 2013
Sponsor
Shanghai University of Traditional Chinese Medicine
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
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Primary Completion Date
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Study Completion Date
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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
Learn more about this trial
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
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