NIPH Clinical Trials Search

Comparative Trial of Proton Therapy and X-ray Therapy for Postoperative Breast Cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Breast cancer
Date of first enrollment	08/05/2026
Target sample size	36
Countries of recruitment
Study type	Interventional
Intervention(s)	Proton therapy

Outcome(s)

Primary Outcome

Incidence rate of radiation dermatitis of grade 3 or higher (according to CTCAE v5.0) two weeks after completion of treatment

Secondary Outcome

Efficacy Evaluation The proportion of patients with confirmed local recurrence and distant recurrence at 1 year after completion of radiotherapy. Safety Evaluation 1.Radiation dermatitis - (1) RISRAS score assessed at the end of treatment, (2) Simultaneously with RISRAS assessment, secondary evaluations will be performed using a device (WSK-P500U, WaveCyber Corporation, Saitama, Japan) to measure temporal changes in skin oil and moisture levels, and erythema will also be assessed using a colorimeter, (3) at 2 weeks, 6 weeks, and 1 year after completion of radiotherapy. - Radiation dermatitis graded according to CTCAE v5.0 at the end of treatment, and at 2 weeks, 6 weeks, and 1 year after completion of radiotherapy. 2.Quality of Life (QOL) assessment: EQ-5D-5L evaluated at the end of treatment, and at 2 weeks, 6 weeks, and 1 year after completion of radiotherapy. 3.Other adverse events: Presence or absence of confirmed local recurrence and distant recurrence within 1 year after completion of radiotherapy.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Eligible participants must meet all of the following criteria, 1.Patients with left-sided breast cancer measuring 5 cm or less (=<T2), without lymph node metastasis (N0) or distant metastasis (M0), who have undergone breast-conserving surgery. 2.Age >= 20 years at the time of enrollment. 3.Able to maintain the supine position with the upper limbs elevated for at least 30 minutes. 4.Written informed consent for participation in the study has been obtained from the patient. 5.WHO Performance Status of 2 or less.
Exclude criteria	Participants meeting any of the following criteria will be excluded from this study: 1.Women who are pregnant or possibly pregnant. 2.Patients with collagen vascular diseases complicated by active systemic sclerosis or systemic lupus erythematosus (SLE). 3.Patients with endogenous psychiatric disorders, such as schizophrenia, or other psychiatric symptoms that are judged to make participation in the study difficult. 4.Patients diagnosed with hereditary diseases associated with a high risk of radiation-induced secondary malignancies, such as Li-Fraumeni syndrome. 5.Patients with infections requiring systemic treatment. 6.Patients weighing 135 kg or more. 7.Patients with a history of radiotherapy to the left breast or chest wall (re-irradiation to the same site). 8.Patients using implanted medical devices such as a ventricular assist device, spinal cord stimulator, or cochlear implant. 9.Patients with a confirmed diagnosis of metastatic brain tumors. 10.Patients with a history of interstitial pneumonia or cardiovascular disease. 11.Breastfeeding women. 12.Any other patients deemed unsuitable for participation by the principal investigator or sub-investigators for medical, psychological, or other reasons.