RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-07
Study Completion:2027-07-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06006806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
  2. * Patients must be equal to or greater than 18 years old.
  3. * The patient must have stage 0, I, II, or III breast cancer
  4. * On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast
  5. * Surgical treatment of the breast must have been lumpectomy or mastectomy
  6. * Patients must have an estrogen receptor (ER) analysis performed on the primary tumor
  7. * Progesterone (PgR) analysis is desired but not mandatory
  8. * No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment
  1. * Stage IV breast cancer
  2. * Non-epithelial breast malignancies such as sarcoma or lymphoma
  3. * Paget's disease of the nipple
  4. * Prior breast or thoracic radiation therapy (RT) for any condition.
  5. * Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  6. * Pregnancy or lactation
  7. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Contacts and Locations

Study Contact

Samantha Hedrick
CONTACT
865-862-1600
shedrick@covhlth.com
Chester Ramsey, PhD
CONTACT
865-331-3161
cramsey@covhlth.com

Principal Investigator

Samantha Hedrick, PhD
PRINCIPAL_INVESTIGATOR
Director of Medical Physics

Study Locations (Sites)

Thompson Proton Center
Knoxville, Tennessee, 37909
United States

Collaborators and Investigators

Sponsor: Thompson Cancer Survival Center

  • Samantha Hedrick, PhD, PRINCIPAL_INVESTIGATOR, Director of Medical Physics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07
Study Completion Date2027-07-07

Study Record Updates

Study Start Date2023-07-07
Study Completion Date2027-07-07

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Breast Cancer Stage I