Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, multicentric, comparative, non randomised, in current care.

Primary objective:

* To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months).

Secondary objectives :

* To calculate the dose of irradiation received by thyroid gland during the treatment.
* To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2).
* To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups.
* To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters.
* To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer

NCT04528225

Breast Neoplasms Hypothyroidism Radiation Toxicity

COMPLETED

The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up

NCT03699098

Head and Neck Cancer

COMPLETED NA

Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers

NCT00336102

Breast Cancer Fatigue Hypothyroidism

COMPLETED

Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

NCT04290663

Thyroid Cancer Intermediate Risk

RECRUITING PHASE3

Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

NCT01295333

Graves Disease (Basedow's Disease)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective, multicentric, comparative, non randomised, in current care study

2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation:

* Group 1 : patients receiving a supra-clavicular irradiation
* Group 2 : patients not receiving a supra-clavicular irradiation.

Schedule

Projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients)

Intermediate study of the results in 30 months

Duration of follow-up of 60 months

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irradiation; Adverse Effect Irradiation Hypothyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

with supraclavicular irradiation

Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Group Type ACTIVE_COMPARATOR

biological sample

Intervention Type BIOLOGICAL

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

supraclavicular irradiation

Intervention Type RADIATION

Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

without supraclavicular irradiation

Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Group Type ACTIVE_COMPARATOR

biological sample

Intervention Type BIOLOGICAL

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biological sample

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

Intervention Type BIOLOGICAL

supraclavicular irradiation

Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women older than 18
* Non metastatic breast cancer, histologically proved, whatever T and N stages and receptors status.
* Breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies)
* Breast cancer requiring an adjuvant radiotherapy
* Treatment by radiotherapy made in participating centers
* Information of patient and signature of the informed consent.

Exclusion Criteria

* Pre-existent dysthyroidism revealed before radiotherapy or at inclusion checkup (THS lower or superior to the standard of the laboratory, whatever the rate of free T4)
* History of thyroid surgery
* Bilateral breast cancer
* History of cervical and/or supra-clavicular radiotherapy
* Lack of social security insurance
* Subjects deprived of free behavior or under administrative control

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No