Actively Recruiting
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
Led by Covenant Health Cancer Center · Updated on 2025-04-08
100
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient consents to participate and has signed the approved consent form
- Age 18 years or older
- Diagnosed with stage 0, I, II, or III breast cancer
- Tumor confirmed as ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma
- Surgical treatment received: lumpectomy or mastectomy
- Estrogen receptor (ER) analysis performed on primary tumor
- Progesterone receptor (PgR) analysis desired but not mandatory
- No serious health conditions affecting treatment completion or skin in treatment area as determined by physician
You will not qualify if you...
- Stage IV breast cancer
- Non-epithelial breast cancers such as sarcoma or lymphoma
- Paget's disease of the nipple
- Prior radiation therapy to breast or chest area for any reason
- Collagen vascular diseases including dermatomyositis with elevated CPK or active rash, systemic lupus erythematosus, or scleroderma
- Pregnancy or breastfeeding
- Psychiatric, addictive, or other conditions preventing study compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
S
Samantha Hedrick
CONTACT
C
Chester Ramsey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
0
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