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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new technique called "Spot Delete" during pencil beam scanning proton therapy to see if it can reduce skin reactions known as radiation dermatitis in breast cancer patients. This study focuses on patients with stage 0 to III breast cancer and uses a computer model to analyze how the energy of the proton beam relates to these skin reactions. The purpose is to compare the skin effects of this new method to historical data from patients who received regular proton therapy without the technique. The study treatment involves planning proton therapy guided by a CT scan to find the best proton placement. The "Spot Delete" software is used during treatment planning to prevent protons from stopping in the skin, which is thought to cause skin redness. Patients receive pencil beam scanning proton therapy with this technique, and their skin reactions are monitored throughout the treatment period and follow-up. Participants will have digital photos taken of their treated skin area to assess redness without revealing their identity. They will complete self-report questionnaires, and medical staff will document skin reactions using standardized scoring systems. Assessments occur at baseline, weekly after every fifth treatment session, at the end of treatment, and at 1 and 6 months post-treatment. Researchers will compare these results to historical rates of skin reactions and measure the linear energy transfer of the proton beam. The study includes regular evaluations over about 10 weeks of treatment and follow-up.
CONDITIONS
Brief 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 and signs an approved consent form
- Age 18 years or older
- Diagnosis of stage 0, I, II, or III breast cancer
- Tumor is ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma
- Has had lumpectomy or mastectomy surgery
- Estrogen receptor (ER) analysis performed on the primary tumor
- Progesterone (PgR) analysis desired but not mandatory
- No serious health conditions affecting ability to complete treatment or skin in treatment area
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
- Collagen vascular diseases like dermatomyositis with high CPK or active rash, systemic lupus erythematosus, or scleroderma
- Pregnancy or breastfeeding
- Psychiatric, addictive, or other disorders preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 weeks
Participants receive Pencil Beam Scanning Proton Therapy using the Spot Delete technique to reduce skin radiation dermatitis. Skin reactions are assessed during therapy.
Weekly visits for skin assessments after every fifth treatment session
Duration - 6 months
Participants are monitored for skin reactions post treatment to assess recovery and long-term effects.
2 visits (1-month and 6-month post treatment)
Trial Site Locations
Total: 1 location
1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
S
Samantha Hedrick
C
Chester Ramsey, PhD
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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