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A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543072
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University

Study Description
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Brief Summary:
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Condition or disease Intervention/treatment
Breast Cancer Drug: Bisphosphonates

Detailed Description:
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects, especially increasing the risk of hyperlipidemia, cardiovascular disease and osteoporosis in postmenopausal women. It is a multicenter prospective observational study. The postmenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures in this population.In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Women With Breast Cancer
Estimated Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
exposure group
exposed to some factors
 Drug: Bisphosphonates
a class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases
control group
not exposed to some factors


Outcome Measures
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Primary Outcome Measures :
  1. The rate of osteoporosis [ Time Frame: 5 years ]
    According to the result of bone mineral density


Secondary Outcome Measures :
  1. The risk of osteoporotic fracture [ Time Frame: 5 years ]
    Calculate the risk of osteoporotic fracture with the WHO Fracture Risk Assessment Tool (FRAX® ) (http://www.shef.ac.uk/FRAX/)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy
Criteria

Inclusion Criteria:

  1. Informed consent form has been signed.
  2. Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.

  3. Postmenopausal women who are defined by any of the following:

    • Previous bilateral oophorectomy;
    • Age ≥ 60 years old;
    • Age <60 years old, menopause at least 12 months, and follicle stimulating hormone [FSH] and estradiol levels in the postmenopausal range.
  4. Plan for adjuvant or neoadjuvant chemotherapy.

Exclusion Criteria:

  1. Those who have already received adjuvant or neoadjuvant chemotherapy.
  2. Those who have chemotherapy contraindications.
  3. Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543072


Contacts
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Contact: Shusen Wang +86-13926168469 wangshs@sysucc.org.cn
Contact: Kuikui Jiang +86-15210589011 jiangkk@sysucc.org.cn

Locations
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China, Guangdong
Shusen Wang
Guanzhou, Guangdong, China
Contact: Shusen Wang, doctor    +86-13926168469    wangshs@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Shusen Wang Sun Yat-sen University
More Information
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Responsible Party: wang shusen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03543072    
Other Study ID Numbers: SCBCG-022
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs