A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer

Completed

• Conditions: Radiation Toxicity; Breast Neoplasms; Hypothyroidism

• Registration Number: NCT04528225
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

This study is to prospectively investigate the incidence of hypothyroidism after postoperative radiotherapy and identify risk factors for development of hypothyroidism. Patients with breast cancer treated with surgery followed by radiotherapy is enrolled. Thyroid function was assessed at baseline and different times after radiotherapy. The radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated, and the dose-effect relationship is analyzed.

Detailed Description

Breast cancer patients treated with radiotherapy after surgery are prospectively enrolled. Thyroid function is evaluated mainly by the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). Thyroid function is regularly assessed before and after radiotherapy. The radiation technique and thyroid dose parameters are assessed. Development of subclinical or biochemical hypothyroidism is noted. The incidence and risk factors of hypothyroidism is analyzed. The dose-volume constraints that correlate with functional impairment of the thyroid in breast cancer patients treated with radiotherapy is discussed.

Study Timeline

• Study Start: 2017-11-15
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Status Verified: 2020-08
• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 729

Inclusion Criteria

Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery.

Exclusion Criteria

Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related hypothyroidism as assessed by CTCAE v4.0	up to 2 years	The subclinical and biochemical hypothyroidism are regularly assessed with the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4).

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China