Skeletal Events of Hormonal Treatment and Radiotherapy in Patient With Breast Cacer
Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
1 other identifier
observational
100
0 countries
N/A
Brief Summary
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 11, 2021
March 1, 2021
Same day
November 25, 2020
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Skeletal events caused by hermonal treatment
Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan
basline
Radiotherapy and arm edema
Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters
Baseline
Interventions
Eligibility Criteria
older patient with breat cancer who receives hormonal treatment and radiothearpy
You may qualify if:
- 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
You may not qualify if:
- Male patients
- Metastatic disease at presentation
- No definitive surgery
- Carcinoma in situ or other rare tumors of the breast as phyllodes tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- residant doctor
Study Record Dates
First Submitted
November 25, 2020
First Posted
March 11, 2021
Study Start
December 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03