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Skeletal Events of Hormonal Treatment and Radiotherapy in Patient With Breast Cacer

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ClinicalTrials.gov Identifier: NCT04792840
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed gamal hussein, Assiut University

Study Description
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Brief Summary:
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy

Condition or disease Intervention/treatment
Breast Cancer Drug: Femara Pill

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.

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Femara Pill
    study effect on bone
    Other Name: radiothearpy

Outcome Measures
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Primary Outcome Measures :
  1. Skeletal events caused by hermonal treatment [ Time Frame: basline ]
    Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan

  2. Radiotherapy and arm edema [ Time Frame: Baseline ]
    Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
older patient with breat cancer who receives hormonal treatment and radiothearpy
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792840


Contacts
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Contact: ahmed g. hussain, residant 0201013736679 aghussain1993@gmial.com
Contact: hanan g. mostafa, prof dr 0201004082002 Mostafahanan36@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: hanan g. mostafa, prof dr Assiut University
Study Director: mohammed a. mohmmed, dr Assiut University
Study Director: maha s. el naggar, dr Assiut University
More Information
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Additional Information:

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Responsible Party: Ahmed gamal hussein, residant doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04792840    
Other Study ID Numbers: events in breast cancer
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs