Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- 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
Ahmed gamal hussein
residant doctor
Assiut University
