Viewing Study NCT06029231



Ignite Creation Date: 2024-05-06 @ 7:27 PM
Last Modification Date: 2024-10-26 @ 3:07 PM
Study NCT ID: NCT06029231
Status: RECRUITING
Last Update Posted: 2024-02-07
First Post: 2023-08-31

Brief Title: Quantifying Radiation-Induced Skin Reactions Establishing the Foundation for Future Prediction Models
Sponsor: China Medical University Hospital
Organization: China Medical University Hospital

Study Overview

Official Title: Quantifying Radiation-Induced Skin Reactions Establishing the Foundation for Future Prediction Models
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Breast cancer has the highest incidence rate among female cancers and breast radiotherapy plays an essential role in the treatment of breast cancer However the acute and chronic skin reactions caused by radiotherapy especially radiation dermatitis have a significant impact on the physical and mental health of breast cancer patients Severe acute radiation dermatitis can affect the patients quality of life and may even lead to treatment interruption thereby affecting treatment efficacy Chronic radiation dermatitis can lead to irreversible skin problems such as radiation-irritated skin and skin pigmentation which can affect the quality of life of breast cancer patients after treatment

This study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who underwent whole-breast radiotherapy after breast conserving surgery The subjects returned to the hospital for evaluation every week during radiotherapy and in the second and sixth weeks after the end of the treatment they received physical examinations and surveys including questionnaire surveys skin observations and measurements The study lasted for 3 months Skin observation items included physiological parameters such as skin moisture temperature melanin transepidermal water loss TEWL and clinical evaluation of skin reactions by physicians Through statistical analysis of skin physiological parameters scientific instruments can quantify the radiation skin reactions traditionally judged by clinical physicians by visual examination and can perform real-time clinical prediction monitoring which can be used to establish a skin reaction prediction model in the future
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None