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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I

In brief

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.

Key facts

Study ID

NCT06006806

Run by

Covenant Health Cancer Center

People needed

100

Starts

2023-07-07

Expected to finish

2030-07-07

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Surgical treatment of the breast must have been lumpectomy or mastectomy
• Patients must have an estrogen receptor (ER) analysis performed on the primary tumor
• Progesterone (PgR) analysis is desired but not mandatory
• No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment

You may not qualify if…

• 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.
• Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
• Pregnancy or lactation
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Where it is running

• Thompson Proton Center — Knoxville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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