About this trial
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to cause skin redness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
Patients must be equal to or greater than 18 years old.
The patient must have stage 0, I, II, or III breast cancer
On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast
Disqualifiers
Stage IV breast cancer
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
Prior breast or thoracic radiation therapy (RT) for any condition.
Trial design
Single group
Treatments tested in this trial
Pencil Beam Scanning Proton Therapy
RadiationPart of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called "Spot Delete" to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process.
Treatment groups
Trial outcomes
Primary outcomes
Reduction in Radiation Dermatitis
"Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.
Secondary outcomes
linear energy transfer (LET) of the proton beam
A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model
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