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Clinical Trials/NCT04792840
NCT04792840UnknownNot Applicable

Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer

Assiut University0 sites100 target enrollmentStarted: December 1, 2021Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
Radiotherapy and arm edema

Study Overview

Brief Summary

study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy

Detailed Description

In the United States, it is estimated that there are more than 3.8 million living women has a history of invasive breast cancer, and 268,600 women will be newly diagnosed in 2019. Sixty-four percent of breast cancer survivors (more than 2.4 million women) are ≥ 65 years, whereas 7% are aged younger than 50 years 1.

The most common treatment of early stage (stage I or II) breast cancer is breast-conserving surgery (BCS) with adjuvant radiation therapy (49%) and 34% of patients undergo mastectomy. In contrary, more than two-thirds (68%) of patients with stage III disease undergo mastectomy and most of them receive adjuvant chemotherapy 2.

Some of the most debilitating morbidity after surgery and radiotherapy for breast cancer is related to treatment of the axilla. This includes persistent arm lymphoedema, impaired shoulder mobility and brachial plexopathy. Other exogenous factors have an influence on the risk of radiotherapy-related morbidity as patients' age and obesity 3.

Lymphedema of the arm occurs in 19.9% of women who undergo axillary lymph node dissection and in 5.6% of women who have a sentinel lymph node biopsy 4. Irradiation of the regional lymph nodes may increase the risk, especially among patients receiving axillary lymph node dissection 5.

Early diagnosis of lymphedema is important for optimizing its treatment and preventing its progression 6. Some forms of cancer rehabilitation may reduce the risk and lessen the severity of this condition 7, 8.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Postmenopausal patients with positive diagnosis of stage 1-3 breast cancer and planned AI (anastrazole, letrozole) adjuvant treatment will be included in the study.
  • Patients without known osteoporosis will included in the study, and before AI treatment began.
  • Conventional RT course must be completed (50 Gy/25 fractions, 2 Gy/fraction, 5 days/week).
  • Patients continue to receive adjuvant hormonal treatment (aromatase inhibitors) or adjuvant target therapy (trastuzumab) while monitoring late toxicities

Exclusion Criteria

  • Male patients
  • Metastatic disease at presentation
  • No definitive surgery
  • Carcinoma in situ or other rare tumors of the breast as phyllodes tumors.

Outcomes

Primary Outcomes

Radiotherapy and arm edema

Time Frame: Baseline

Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters

Skeletal events caused by hermonal treatment

Time Frame: basline

Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed gamal hussein

residant doctor

Assiut University

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