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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-16009046 |
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Date of registration:
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2016-08-19 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study on the effect of Xiaojin pills combined with levothyroxine in the treatment of breast cancer patients with thyroid nodule.
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Scientific title:
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Clinical study on the effect of Xiaojin pills combined with levothyroxine in the treatment of breast cancer patients with thyroid nodule. |
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Date of first enrolment:
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2016-08-25 |
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Target sample size:
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Group 1:120;Group 2:120;Group 3::120; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=15323 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Ren Guosheng; Kong Lingquan
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Address:
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1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, China
400016
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Telephone:
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+86 13101380893 |
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Email:
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huihuikp@163.com |
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Affiliation:
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Department of Endocrine and Breast Surgery of the First Affiliated Hospital of Chongqing Medical University |
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Name:
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Wu Yutuan; XuZhou
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Address:
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1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, China
400016
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Telephone:
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+86 18707190325 |
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Email:
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wyutuan@163.com |
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Affiliation:
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Department of Endocrine and Breast Surgery of the First Affiliated Hospital of Chongqing Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis as breast cancer according to clinical practice guideline;
2. Performed the operation and all cycles of chemotherapy;
3. Volunteered for this study and informed consent was abtained from the participants;
4. Aged between 18 and 75 years old;
5. Detected thyroid nodule by color Doppler ultrasonography, whether single nodule or multiple nodules, and the nodules <2cm with clear margin and without malignant signs;
6. Normal thyroid function;
7. Informed consent was abtained from the participants.
Exclusion criteria: 1. Those who havent finished systemic treatment of breast cancer;
2. Thyroid dysfunction;
3. Those whos thyroid malignant cant be ruled out by color Doppler ultrasonography;
4. Coexistence of other serious medical conditions, such as serious infections, organs failure, serious injury, etc.;
5. Pregnant women;
6. Allergic to Xiaojin pills;
7. Liver function and renal function dysfunction(the values higher than one time of normal).
Age minimum:
18
Age maximum:
75
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast cancer
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Intervention(s)
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Group 1:Xiaojin pills monotherapy;Group 2:levothyroxine monotherapy;Group 3::Xiaojin pills and levothyroxine combination therapy;
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Primary Outcome(s)
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Cure rate;Excellent rate;Effective rate;Ineffectiveness rate;Total effective rate;
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Secondary Outcome(s)
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Side effects;
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Source(s) of Monetary Support
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Pharmaceutical companies funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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