A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer

NCT04528225 | Completed

• 1 other identifier: NCC2444
• Study Type: observational
• Target: 729
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Hypothyroidism; Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related hypothyroidism as assessed by CTCAE v4.0

  The subclinical and biochemical hypothyroidism are regularly assessed with the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4).

  up to 2 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients treated with radiotherapy after surgery are enrolled.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Hypothyroidism; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Thyroid Diseases; Endocrine System Diseases; Wounds and Injuries

Study Officials

• Shu-lian Wang, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 27, 2020
• Study Start: November 15, 2017
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: January 13, 2026

Record last verified: 2020-08

Locations

CN (1)