NCT06006806 · Covenant Health Cancer Center
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
What this study 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Reduction in Radiation Dermatitis
Time frame: weekly assessments over 10 weeks
"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. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Knoxville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2025 · Source of record for eligibility and locations