Back to search results

Evaluating 'Spot Delete' in Proton Therapy for Breast Cancer Skin Reactions

This study is looking at how a special technique called "Spot Delete" can reduce skin reactions (radiation dermatitis) in breast cancer patients receiving Pencil Beam Scanning Proton Therapy. Researchers want to see if "Spot Delete" prevents protons from stopping in the skin, which is thought to cause redness. You might be able to join if you are a woman, 18 or older, and have Stage 0, I, II, or III breast cancer. The study will measure how much skin redness occurs over 10 weeks. Success would mean less skin redness compared to past patients who didn't use "Spot Delete." The current status of this study is unclear, and it plans to enroll 100 participants.

Study design
This interventional study plans to enroll 100 women with breast cancer. It will compare skin reactions in patients receiving Pencil Beam Scanning Proton Therapy with the "Spot Delete" technique to historical data.
What's involved
You will have a CT scan to plan your proton therapy. Digital photos of your skin will be taken, and you will complete self-report questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your skin reactions will be assessed weekly over 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06006806

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

Recruiting
NAAges 18+InterventionalSupportive care
Covenant Health Cancer Center
~100 participants
Updated 2025-04-08 on ClinicalTrials.gov
What's tested:Pencil Beam Scanning Proton Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in Radiation Dermatitis
Measured over weekly assessments over 10 weeks

Conditions

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

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Samantha Hedrick, PhD · PRINCIPAL_INVESTIGATOR · Director of Medical Physics

Who to contact

Samantha Hedrick
[email protected]
865-862-1600
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Reduction in Radiation Dermatitisweekly 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.