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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCovenant Health Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pencil Beam Scanning Proton Therapy

    Radiation

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Reduction in Radiation Dermatitis

"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.

Time frame
weekly assessments over 10 weeks

Secondary outcomes

1

linear energy transfer (LET) of the proton beam

A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model

Time frame
LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.

Other outcomes

Sponsors and contacts

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