Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04792840 |
Other study ID # |
events in breast cancer |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2021 |
Est. completion date |
December 2021 |
Study information
Verified date |
March 2021 |
Source |
Assiut University |
Contact |
ahmed g. hussain, residant |
Phone |
0201013736679 |
Email |
aghussain1993[@]gmial.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal
therapy and radiothearpy
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.
Treatment with adjuvant aromatase inhibitors (AI), which is generally reserved for
postmenopausal women, can cause osteoporosis 9.
Osteoporosis, a process of bone mineral density (BMD) reduction, is accelerated by estrogen
deficiency in postmeno¬pausal women. Tamoxifen reduces BMD in premenopausal women, while
promotes bone formation in postmenopausal patients. On the other hand, adjuvant aromatase
inhibitors (AIs) therapy enhances the BMD decrease to about 2.5% per year, due to a long
lasting significant deprivation of circula¬tory and tissue estrogens 10. In the bone
companion study of the MA.17 trial, patients treated with anastrozole reported a significant
decreases in BMD (~4%), compared to those treated with tamoxifen 11.
Dual energies' X ray absorptiometry (DXA) scan is the current validated 'gold standard' for
the diagnosis of osteoporosis, fracture risk estimation and follow up of anti osteoporotic
treatment 12-14, since it is non invasive, simple, precise, fast, less expensive than other
imaging techniques, including computed tomography and magnetic resonance imaging, and more
sensitive than quantitative ultrasound (QUS) 15.