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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a method called “Spot Delete” can reduce skin reactions during pencil beam scanning proton therapy, a type of radiation treatment. It is for adults with stage 0–III breast cancer who have had breast surgery. Researchers will also use a computer model to study how proton beam energy relates to skin reactions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to join the study and sign a consent form.
  • Be age 18 or older.
  • Have stage 0, I, II, or III breast cancer.
  • Have tissue tests showing DCIS (cancer inside the milk ducts) or invasive adenocarcinoma (breast cancer that has grown into nearby tissue).
  • Have had a lumpectomy (removal of the tumor) or mastectomy (removal of the breast).
  • Have had the original tumor tested for estrogen receptors, which show whether estrogen may help the cancer grow.
  • Have no serious health problem that the doctor thinks would prevent finishing treatment or affect skin in the treatment area.

Who can't join

  • Have stage IV breast cancer, which has spread to distant parts of the body.
  • Have a breast cancer type such as sarcoma or lymphoma.
  • Have Paget’s disease of the nipple, a type of cancer affecting the nipple.
  • Have had radiation treatment to the breast or chest for any reason.
  • Have certain immune system diseases: dermatomyositis with a high CPK blood test result or an active rash, lupus, or scleroderma. These diseases can affect muscles, skin, or other tissues.
  • Be pregnant or breastfeeding.
  • Have a mental health condition, addiction, or another condition that the study doctor thinks would prevent meeting study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TN