RECRUITING

Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS 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 head \& neck patients treated with PBS. The investigators 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.

Official Title

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

Quick Facts

Study Start:2023-12-13
Study Completion:2030-01-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06183268

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:ALL
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 ≥ 18 years old.
  3. * Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx
  4. * Carcinoma of the neck of unknown primary site origin may be included if p16 positive
  5. * Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases
  6. * Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time
  7. * Previous or concurrent chemotherapy is allowed
  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. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  2. * Head and neck radiotherapy that does NOT include at least one cervical lymph node level (I, II, III, IV, or V) in the target volume.
  3. * Children
  4. * Women who are pregnant.

Contacts and Locations

Study Contact

Samantha Hedrick, PhD, DABR
CONTACT
865-862-1600
shedrick@CovHlth.com
Catherine Duke-Taylor, BS
CONTACT
865-862-1600
cduke@CovHlth.com

Principal Investigator

Samantha Hedrick, PhD, DABR
PRINCIPAL_INVESTIGATOR
Thompson Proton Center, 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, DABR, PRINCIPAL_INVESTIGATOR, Thompson Proton Center, 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 Date2023-12-13
Study Completion Date2030-01-02

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2030-01-02

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Head and Neck Carcinoma