Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer
A Prospective Study to Assess Both Thyroid Abnormity Incidence In Chinese Women With Newly Diagnosed Breast Cancer and Thyroid Toxicity of Breast Cancer Patients Undergoing Chemotherapy
1 other identifier
observational
400
1 country
1
Brief Summary
Breast cancer is one of the most common cancers in China. Even though advances in the field of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. The cytotoxic therapies are generally associated with some immediate or otherwise delayed side effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological systems. The effect of chemotherapy on endocrine system, however, is comparatively less envisaged. Several epidemiological studies show a positive association between plasma thyroid hormones levels and breast cancer risk. Thyroid dysfunction is emerging as a variably common endocrine toxicity of several anticancer drugs. Due to the scarcity of data on the functioning of thyroid gland during chemotherapy in a large scale group, the present study was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or structure in these breast cancer patients undergoing at least four cycles of chemotherapy.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2017
CompletedStudy Start
First participant enrolled
June 4, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 7, 2017
June 1, 2017
1.8 years
May 28, 2017
June 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants newly diagnosed with breast cancer
Rate of thyroid function (measured by chemiluminescence methods) or structure (measured by ultrasonic imaging) abnormity at the time of diagnosis and during chemotherapeutic period will be reported.
1 week around the indicated detection point
Study Arms (2)
Observational group
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy
Control group
Healthy Volunteers
Interventions
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
Eligibility Criteria
Newly diagnosed female breast cancer
You may qualify if:
- Female patients with histologically or cytologically proven primary breast cancer;
- Age \>18 years;
- ECOG Performance Status: 0-2;
- Life Expectancy: 3 months or more;
- No previous anti-cancer therapy;
- Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
- Adequate hematological, liver, and kidney functions.
You may not qualify if:
- Pregnancy or lactation;
- History of other malignancy or secondary breast cancer;
- History of thyroid disease;
- History of drug addiction or abuse;
- History of immunodeficiency disease;
- Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
- Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
- Inability to understand and agree to informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiong Wu, M.D.,Ph.D.
First Affiliated Hospital of Bengbu Medical College
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2017
First Posted
June 6, 2017
Study Start
June 4, 2017
Primary Completion
April 1, 2019
Study Completion
June 1, 2019
Last Updated
June 7, 2017
Record last verified: 2017-06