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

NCT ID: NCT03177902

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-04

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female Thyroid Gland

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational group

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

Chemotherapy

Intervention Type DRUG

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

Control group

Healthy Volunteers

No interventions assigned to this group

Interventions

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Chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qiong Wu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiong Wu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Bengbu Medical College

Locations

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Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Yang, M.D.,Ph.D.

Role: CONTACT

+86-552-3086178

Facility Contacts

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Yan Yang, M.D., Ph.D.

Role: primary

+86-552-3086178

Other Identifiers

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BYEC20170502

Identifier Type: -

Identifier Source: org_study_id

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