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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female; Thyroid Gland
• Intervention / Treatment: Drug: Chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed female breast cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Healthy Volunteers
Observational group; Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy	Drug: Chemotherapy; Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Bengbu Medical College
• Investigators: Principal Investigator: Qiong Wu, M.D.,Ph.D., First Affiliated Hospital of Bengbu Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2017
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 3, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Breast Diseases; Breast Neoplasms; Thyroid Diseases
• Other Study ID Numbers: BYEC20170502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No