Evaluating skin reactions in breast cancer patients receiving proton therapy
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
NA · Covenant Health Cancer Center · NCT06006806
This study is testing a new technique to see if it can help reduce skin reactions in breast cancer patients getting proton therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Covenant Health Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06006806 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage 0, I, II, or III breast cancer who have undergone surgical treatment.
Not a fit: Patients with stage IV breast cancer or those who have received prior radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced skin toxicity for breast cancer patients undergoing proton therapy.
How similar studies have performed: While this approach is innovative, similar studies have shown varying degrees of success in reducing skin toxicity with advanced radiation techniques.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Knoxville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I