NCT06006806

Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Covenant Health Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

During the study, digital photos of patients' skin will be taken to assess the amount of redness, without revealing their identity. Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. In this study, we aim to test the hypothesis that the "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. To evaluate this, we will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment. The effectiveness of the technique will be evaluated by measuring and documenting the degree of skin reactions in patients undergoing proton therapy with the Spot Delete technique. Digital photographs of the treatment area will be taken to assess radiation dermatitis using the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 and using the Radiation Dermatitis Severity (RDS) scoring system. Radiation dermatitis will be assessed at baseline, weekly after every fifth treatment session, at the end of treatment, and at 2 post treatment follow-up appointments (e.g. 1-month and 6-months post treatment).These results will be compared to historical occurrence rates of skin reactions in regular proton therapy.

Conditions

• Breast Cancer
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Cancer Stage I

Interventions

Type	Name	Description
RADIATION	Pencil Beam Scanning Proton Therapy	Part 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.

Timeline

• Start date: 2023-07-07
• Primary completion: 2028-07-07
• Completion: 2030-07-07
• First posted: 2023-08-23
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study