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Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer

Key facts

Where
Bengbu, ChinaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Source: NCT03177902, who can take part

Where in China

  • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The First Affiliated Hospital of Bengbu Medical University
Trial code
NCT03177902
Record updated
4 September 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry; Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; History of other malignancy or secondary breast cancer; History of thyroid disease; History of drug addiction or abuse; History of immunodeficiency disease; Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; Pregnancy or lactation; Inability to understand and agree to informed consent.

ClinicalTrials.gov NCT03177902