Evaluating skin reactions in breast cancer patients receiving proton therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines skin reactions, specifically radiation dermatitis, in breast cancer patients undergoing pencil beam scanning proton therapy. Researchers will test a technique called 'Spot Delete' to determine if it can reduce skin reactions compared to historical data from patients treated without this method. The study involves creating individualized treatment plans based on CT scans to optimize proton beam placement. Skin reactions will be assessed through digital photographs and self-report questionnaires, with evaluations occurring at various treatment intervals.

Why it matters

Who can join: the full rules

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 it's running

• Thompson Proton Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Samantha Hedrick, PhD — Director of Medical Physics
• Study coordinator: Samantha Hedrick
• Email: shedrick@covhlth.com
• Phone: 865-862-1600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.