Thyroid Dysfunction Induced by Radiotherapy Treatment in Patients with Breast Cancer

NCT ID: NCT06820554

Last Updated: 2025-02-11

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

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-05-01

Brief Summary

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Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .

However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .

The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .

In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .

Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .

Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.

Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.

the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer

Detailed Description

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Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .

However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .

The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .

In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .

Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .

Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.

Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.

the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer

Conditions

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Brest Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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brest cancer

breast cancer patients who will be indicated for postoperative ( mastectomy /BCT) adjuvant radiotherapy who are\>18 yrs old breast cancer ( pathological proved ) Stage II/III breast cancer High risk local recurrence ( LVI/ G3/ LN positive) Non metastatic breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* \>18 yrs old breast cancer ( pathological proved )
* Stage II/III breast cancer
* High risk local recurrence ( LVI/ G3/ LN positive)
* Non metastatic breast cancer

Exclusion Criteria

* Thyriod dysfunction of any othe cause( no known pretreatment primary thyroid disease or dysfunction; no prior thyroid surgery; and no prior RT that involved the hypothalamic-pituitary axis or thyroid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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fatmaelzahraa mohamed said

residant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TD radio brest cancer

Identifier Type: -

Identifier Source: org_study_id

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