The First Affiliated Hospital of Bengbu Medical University
Phase
Observational
Started
2017-06-04
Last updated
2026-09-04
Condition(s) studied
Breast Cancer FemaleThyroid Gland
Investigational drug(s) / intervention(s)
Chemotherapy
Chemotherapy: Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female patients with histologically or cytologically proven primary breast cancer;
2. Age \>18 years;
3. ECOG Performance Status: 0-2;
4. Life Expectancy: 3 months or more;
5. No previous anti-cancer therapy;
6. Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
7. Adequate hematological, liver, and kidney functions.
Exclusion Criteria:
1. Pregnancy or lactation;
2. History of other malignancy or secondary breast cancer;
3. History of thyroid disease;
4. History of drug addiction or abuse;
5. History of immunodeficiency disease;
6. Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
7. Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
8. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
9. Inability to understand and agree to informed consent.
Primary outcome measure(s)
Number of participants newly diagnosed with breast cancer — 1 week around the indicated detection point 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.
Trial sites (1)
Facility
City
Region
Status
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu
Anhui
Recruiting
More The First Affiliated Hospital of Bengbu Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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