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Radiotherapy Side Effect / Hypofractionated radiation therapy · Observational Study
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational cohort study registered at ClinicalTrials.gov tracking toxicities and cosmetic outcomes in 500 breast cancer patients undergoing hypofractionated radiotherapy. The study is currently active but not recruiting, with no results yet posted in the registry record. Findings, when available, will provide real-world longitudinal data on radiotherapy side effects over 5 years but will lack a comparator arm.
Observational. Radiotherapy Side Effect; Female; age from 18 Years; to 85 Years. Intervention: Hypofractionated radiation therapy. n = 500. 1 site: South Korea.
This is a prospective observational cohort study registered at ClinicalTrials.gov tracking toxicities and cosmetic outcomes in 500 breast cancer patients undergoing hypofractionated radiotherapy. The study is currently active but not recruiting, with no results yet posted in the registry record. Findings, when available, will provide real-world longitudinal data on radiotherapy side effects over 5 years but will lack a comparator arm.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
When results become available, this study will provide longitudinal real-world evidence on cosmetic and toxicity outcomes following hypofractionated breast radiotherapy, informing patient counselling and technique optimization. The lack of a control arm limits causal inference but the multi-method assessment (photographs, fibrometer, patient-reported outcomes, physician toxicity grading) will characterize the full burden of side effects.
This is an active observational cohort study with planned enrollment of 500 participants tracking cosmesis and fibrosis outcomes over 5 years; no results are reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
When results become available, this study will provide longitudinal real-world evidence on cosmetic and toxicity outcomes following hypofractionated breast radiotherapy, informing patient counselling and technique optimization. The lack of a control arm limits causal inference but the multi-method assessment (photographs, fibrometer, patient-reported outcomes, physician toxicity grading) will characterize the full burden of side effects.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05775757). This is a study registration, not published results. Lead sponsor: Samsung Medical Center. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Radiotherapy Side Effect. Interventions: RADIATION: Hypofractionated radiation therapy. Primary outcome measures: Change of cosmesis from baseline , After 2-3 weeks after the start of radiation therapy (During radiation therapy); Change of cosmesis from baseline , 2-3 weeks after the completion of radiation therapy; Change of cosmesis from baseline , 6 months after radiation therapy; Change of cosmesis from baseline , 1 year after radiation therapy; Change of cosmesis from baseline , 2 year after radiation therapy; Change of cosmesis from baseline , 5 year after radiation therapy; Change of fibrosis from baseline , After 2-3 weeks after the start of radiation therapy (During radiation therapy); Change of fibrosis from baseline , 2-3 weeks after the completion of radiation therapy; Change of fibrosis from baseline , 6 months after radiation therapy; Change of fibrosis from baseline , 1 year after radiation therapy; Change of fibrosis from baseline , 2 year after radiation therapy; Change of fibrosis from baseline , 5 year after radiation therapy; Change of patient-reported outcome from baseline , After 2-3 weeks after the start of radiation therapy (During radiation therapy); Change of patient-reported outcome from baseline , 2-3 weeks after the completion of radiation therapy; Change of patient-reported outcome from baseline , 6 months after radiation therapy; Change of patient-reported outcome from baseline , 1 year after radiation therapy; Change of patient-reported outcome from baseline , 2 year after radiation therapy; Change of patient-reported outcome from baseline , 5 year after radiation therapy; Physician assessed toxicity , After 2-3 weeks after the start of radiation therapy; Physician assessed toxicity , 2-3 weeks after the completion of radiation therapy; Physician assessed toxicity , 6 months after radiation therapy; Physician assessed toxicity , 1 year after radiation therapy; Physician assessed toxicity , 2 year after radiation therapy; Physician assessed toxicity , 5 year after radiation therapy. Brief summary: 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
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