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

• Sponsor: First Affiliated Hospital Bengbu Medical College (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03177902
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female; Thyroid Gland	Drug: Chemotherapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jun 4, 2017
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.
Control group Healthy Volunteers

Outcome Measures

Primary Outcome Measures

1. Number of participants newly diagnosed with breast cancer [1 week around the indicated detection point]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China	233004

Sponsors and Collaborators

• First Affiliated Hospital Bengbu Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qiong Wu, Principal Investigator, First Affiliated Hospital Bengbu Medical College
• ClinicalTrials.gov Identifier: NCT03177902
• Other Study ID Numbers: BYEC20170502
• First Posted: Jun 6, 2017
• Last Update Posted: Jun 7, 2017
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Thyroid Diseases

Study Results

No Results Posted as of Jun 7, 2017