SMC Radiation Oncology Breast Cancer Cohort Study
ConditionRadiotherapy Side Effect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-85
SponsorSamsung Medical Center
About this trial
The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.
The main question it aims to answer are:
* Changes in breast skin * Factors related to breast skin changes * Patient-reported outcomes * Cosmetic outcomes
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
* Photographs * Fibrometer * Questionnaires (BREAST-Q) * CTCAE version 4.03 evaluated by treating physicians
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer treated with curative surgery
Disqualifiers
History of thoracic radiation therapy
Trial population
Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hypofractionated radiation therapy
RadiationBoth 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Time frame
After 2-3 weeks after the start of radiation therapy (During radiation therapy)2
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Time frame
2-3 weeks after the completion of radiation therapy3
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Time frame
6 months after radiation therapy4
Change of cosmesis from baseline
Evaluated by two blinded independent physicians based on photographs
Time frame
1 year after radiation therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov