RecruitingNot ApplicableNCT06006806

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

Sponsor

Covenant Health Cancer Center

Enrollment

100 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the effects of proton beam radiation therapy on skin in patients with breast cancer, specifically looking at how much skin irritation occurs and how the body's tissue responds to this newer form of radiation. **You may be eligible if:** - You are 18 or older - You have been diagnosed with stage 0, I, II, or III breast cancer - Your cancer is ductal carcinoma in situ (DCIS) or invasive adenocarcinoma - You had a lumpectomy or mastectomy - You have had an estrogen receptor test done on your tumor **You may NOT be eligible if:** - You have stage IV (metastatic) breast cancer - You have a non-typical breast cancer such as sarcoma or lymphoma - You have had prior radiation to the breast or chest - You have certain connective tissue diseases (like lupus or scleroderma) - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPencil 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.

Locations(1)

Thompson Proton Center

Knoxville, Tennessee, United States

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NCT06006806

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