Clinical trial · Interventional
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 "Spot Delete" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to cause skin redness.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pencil Beam Scanning Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Reduction in Radiation Dermatitis
- timeFrame
- weekly assessments over 10 weeks
- description
- "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.
Secondary outcomes (1)
- measure
- linear energy transfer (LET) of the proton beam
- timeFrame
- LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.
- description
- A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available