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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Covenant Health Cancer Center
Study ID
NCT06006806
Status
Recruiting
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Conditions

  • Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 7, 2023
Status verified
Apr 2025
Primary completion
Jul 7, 2028
Completion
Jul 7, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Primary Outcome Measure

Reduction in Radiation Dermatitis [ Time Frame: weekly assessments over 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thompson Proton CenterKnoxvilleTennessee37909
Casey Mastio-Partridge, BS, MLS
[email protected]
865-331-8216
Jessica M Severt, RN, BSN
[email protected]
865-331-4966
Ryan Grover, MD (SUB_INVESTIGATOR)
Brion Shin, MD (SUB_INVESTIGATOR)
Allen Meek, MD (SUB_INVESTIGATOR)
Chester Ramsey, Ph.D (SUB_INVESTIGATOR)
Samantha Hedrick, Ph.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Knoxville, TN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Thompson Proton Center· Knoxville, TN

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