Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Female | Drug: statins Behavioral: Dietary intervention group (control group) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 314 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism |
Actual Study Start Date : | March 28, 2019 |
Estimated Primary Completion Date : | May 28, 2024 |
Estimated Study Completion Date : | June 28, 2024 |
Arm | Intervention/treatment |
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Experimental: Statin therapy (experimental group)
On the basis of guiding patients to control their diet and improve their lifestyle, etc. Simvastatin 20mg/d QN Po (dosage can be adjusted according to the blood lipid level of each reexamination) Atorvastatin 10mg/d QN Po (patients who cannot tolerate the side effects of simvastatin may consider replacing this drug) |
Drug: statins
On the basis of dietary intervention. Simvastatin 20mg/d QN Po (half an hour before bedtime) (dosage can be adjusted according to other indicators of blood lipid level in each review), atorvastatin 10mg/d QN Po (half an hour before bedtime) (patients who can not tolerate the side effects of simvastatin can consider replacing this drug).
Other Names:
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Dietary intervention group (control group)
Guiding patients to control diet, improve lifestyle, etc.
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Behavioral: Dietary intervention group (control group)
Restriction of dietary components that increase LDL-C Saturated Fatty Acids Less than 7% of total energy Dietary cholesterol < 300 mg/d Increasing Dietary Ingredients for Reducing LDL-C Phytosterol 2~3 g/d Water soluble dietary fiber 10~25 g/d total energy Adjusted to maintain ideal weight or lose weight Physical activity Maintain moderate intensity exercise and consume at least 200 kcal of calories per day
Other Name: Dietary and motor regulation
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | female breast cancer patients |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with chronic underlying liver diseases who have abnormal liver function and/or clinical manifestations:
Serum total bilirubin > 2.5 *ULN; or INR > 1.5 although there was no increase in bilirubin Serum ALT or AST > 3 *ULN; Alkaline phosphatase > 2.5 *ULN; Elevated ALT or AST may gradually recover, but with progressively increased fatigue, nausea and vomiting, fever, right upper abdominal pain or tenderness.
High-risk ASCVD patients (in accordance with one of the following circumstances):
LDL-C>4.9 mmol/L or TC>7.2 mmol/L Diabetic patients with 1.8 mmol/L < LDL-C < 4.9 mmol/L (or) 3.1 mmol/L < TC < 7.2 mmol/L and age < 40 years
The 10-year risk of ASCVD was moderate and younger than 55 years old. The remaining life risk was assessed. Those with any of the following two or more risk factors are defined as high risk:
Systolic or diastolic blood pressure (> 160 mmHg) or (> 100 mmHg)
Other serious diseases, including:
Congestive heart failure (NYHA grade II, III, IV); dyspnea at rest or requiring oxygen therapy; severe infection; uncontrolled diabetes mellitus;
Contact: Xuefei Wang, M.D. | 008613001289600 | 1210548954@qq.com | |
Contact: Qiang Sun, M.D. | 008618801038718 | 799692578@qq.com |
China, Beijing | |
PUMCH | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Xu Hui, M.D. 0086-13810399955 pumchkyc@126.com | |
Principal Investigator: Xuefei Wang, M.D. |
Principal Investigator: | Xuefei Wang, M.D. | PUMCH |
Tracking Information | |||||||||
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First Submitted Date ICMJE | March 30, 2019 | ||||||||
First Posted Date ICMJE | June 3, 2019 | ||||||||
Last Update Posted Date | August 14, 2019 | ||||||||
Actual Study Start Date ICMJE | March 28, 2019 | ||||||||
Estimated Primary Completion Date | May 28, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
DFS [ Time Frame: 5 years ] Disease free survival
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
OS [ Time Frame: 5 years ] Overall survival
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Survival Benefits of Statins in Breast Cancer Patients | ||||||||
Official Title ICMJE | Survival Benefits of Statins in Breast Cancer Patients With Abnormal Lipid Metabolism | ||||||||
Brief Summary | In this study, we compared the survival benefit of breast cancer patients with dyslipidemia (low and medium risk of ASCVD). The control group used dietary intervention instead of statins intervention. The main endpoint was 5 years DFS. The subjects were breast cancer patients. | ||||||||
Detailed Description | A randomized, open, blank controlled, single-center clinical trial was conducted to compare the survival benefits of statins in breast cancer patients with dyslipidemia (low and medium risk of ASCVD). The control group used dietary intervention instead of statins. The main endpoint was 3 and 5 years DFS. The subjects were breast cancer patients. In this study, 348 patients were randomly divided into two groups according to patients' wishes and written informed consent. The experimental group: control group = 1:1. Subjects were screened and administered continuously until the disease progressed and the toxicity was intolerable. Informed consent was withdrawn or the researcher decided that the drug must be discontinued. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A randomized, open, blank controlled, single-center clinical trial. The control group used dietary intervention instead of statins. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer Female | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
314 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 28, 2024 | ||||||||
Estimated Primary Completion Date | May 28, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03971019 | ||||||||
Other Study ID Numbers ICMJE | PUMCH-SBSBC | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Peking Union Medical College Hospital | ||||||||
Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Peking Union Medical College Hospital | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |