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

Launched by THOMPSON CANCER SURVIVAL CENTER · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to reduce skin reactions, known as radiation dermatitis, in women with breast cancer who are receiving a type of treatment called pencil beam scanning proton therapy. The researchers are testing a special technique called "Spot Delete" to see if it can help minimize these skin issues. They will also use a computer model to understand how the energy from the proton beam affects the skin. The study will involve creating a specific treatment plan based on a CT scan, which helps doctors target the proton beam accurately.

To participate in this trial, women must be at least 18 years old and have stages 0, I, II, or III breast cancer, specifically ductal carcinoma in-situ or invasive adenocarcinoma. Participants need to have had surgery, like a lumpectomy or mastectomy, and should not have any serious health conditions that could interfere with the treatment. Those who join the study can expect to undergo proton therapy with the possibility of reduced skin side effects, and they will be closely monitored throughout the process. It's important to note that women with advanced breast cancer or certain other medical conditions may not be eligible.

Gender

FEMALE

Eligibility criteria

• 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.