Trials / Unknown
UnknownNCT06029231
Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- China Medical University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 patient's 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.
Conditions
Timeline
- Start date
- 2023-10-09
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
- First posted
- 2023-09-08
- Last updated
- 2024-02-07
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT06029231. Inclusion in this directory is not an endorsement.