Clinical trial NCT05775757: SMC Radiation Oncology Breast Cancer Cohort Study
Official title: Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiotherapy Side Effect
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any breast cancer patients treated with curative surgery is eligible except for history of thoracic 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


Eligibility criteria: Inclusion Criteria:

* Breast cancer treated with curative surgery

Exclusion Criteria:

* History of thoracic radiation therapy

Primary outcomes:
measure: Change of cosmesis from baseline
timeFrame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
measure: Change of cosmesis from baseline
timeFrame: 2-3 weeks after the completion of radiation therapy
measure: Change of cosmesis from baseline
timeFrame: 6 months after radiation therapy
measure: Change of cosmesis from baseline
timeFrame: 1 year after radiation therapy
measure: Change of cosmesis from baseline
timeFrame: 2 year after radiation therapy
measure: Change of cosmesis from baseline
timeFrame: 5 year after radiation therapy
measure: Change of fibrosis from baseline
timeFrame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
measure: Change of fibrosis from baseline
timeFrame: 2-3 weeks after the completion of radiation therapy
measure: Change of fibrosis from baseline
timeFrame: 6 months after radiation therapy
measure: Change of fibrosis from baseline
timeFrame: 1 year after radiation therapy
measure: Change of fibrosis from baseline
timeFrame: 2 year after radiation therapy
measure: Change of fibrosis from baseline
timeFrame: 5 year after radiation therapy
measure: Change of patient-reported outcome from baseline
timeFrame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)
measure: Change of patient-reported outcome from baseline
timeFrame: 2-3 weeks after the completion of radiation therapy
measure: Change of patient-reported outcome from baseline
timeFrame: 6 months after radiation therapy
measure: Change of patient-reported outcome from baseline
timeFrame: 1 year after radiation therapy
measure: Change of patient-reported outcome from baseline
timeFrame: 2 year after radiation therapy
measure: Change of patient-reported outcome from baseline
timeFrame: 5 year after radiation therapy
measure: Physician assessed toxicity
timeFrame: After 2-3 weeks after the start of radiation therapy
measure: Physician assessed toxicity
timeFrame: 2-3 weeks after the completion of radiation therapy
measure: Physician assessed toxicity
timeFrame: 6 months after radiation therapy
measure: Physician assessed toxicity
timeFrame: 1 year after radiation therapy
measure: Physician assessed toxicity
timeFrame: 2 year after radiation therapy
measure: Physician assessed toxicity
timeFrame: 5 year after radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Haeyoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: