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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177902
• Other study ID #: BYEC20170502
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2017
• Last updated: June 6, 2017
• Start date: June 4, 2017
• Est. completion date: June 2019

Study information

• Verified date: June 2017
• Source: First Affiliated Hospital Bengbu Medical College
• Contact: Yan Yang, M.D.,Ph.D.
• Phone: +86-552-3086178
• Email: qiannianhupo[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Thyroid Diseases
• Thyroid Gland

Intervention

Drug:
• Chemotherapy
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.

Locations

Country	Name	City	State
China	Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Bengbu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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