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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-85
SponsorThe First Affiliated Hospital of Bengbu Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients with histologically or cytologically proven primary breast cancer;

Age >18 years;

ECOG Performance Status: 0-2;

Life Expectancy: 3 months or more;

Disqualifiers

Pregnancy or lactation;

History of other malignancy or secondary breast cancer;

History of thyroid disease;

History of drug addiction or abuse;

Trial population

Newly diagnosed female breast cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Chemotherapy

    Drug

    Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Observational group1 intervention
Group B: Control group0 interventions

Trial outcomes

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.

Time frame
1 week around the indicated detection point

Secondary outcomes

Other outcomes

Sponsors and contacts

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