Status:
RECRUITING
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
Lead Sponsor:
Thompson Cancer Survival Center
Conditions:
Breast Cancer
Breast Cancer Stage II
Eligibility:
FEMALE
18+ years
Phase:
NA
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 "...
Detailed Description
During the study, digital photos of patients' skin will be taken to assess the amount of redness, without revealing their identity. Patients will be given a self-report questionnaire and medical staff...
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.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 7 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06006806
Start Date
July 7 2023
End Date
July 7 2030
Last Update
April 8 2025
Active Locations (1)
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1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909