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

NCT06006806 | Recruiting FDA Device

• 1 other identifier: 2023-474 INV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Stage I

Outcome Measures

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.

  weekly assessments over 10 weeks

Secondary Outcomes (1)

• linear energy transfer (LET) of the proton beam

  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.

Interventions

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.

Also known as: Spot Delete

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men are not eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Covenant Health Cancer Center: lead

Study Sites (1)

Thompson Proton Center

Knoxville, Tennessee, 37909, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samantha Hedrick, PhD

  Director of Medical Physics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Hedrick

CONTACT

865-862-1600; shedrick@covhlth.com

Chester Ramsey, PhD

CONTACT

865-331-3161; cramsey@covhlth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The goal of this study is to measure skin reactions during proton therapy for 100 patients over a period of three years.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 23, 2023
• Study Start: July 7, 2023
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): July 7, 2030
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)