Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma
• Intervention / Treatment: Radiation: Spot Delete

Detailed 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. 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 increase skin dose and thus risk and magnitude of radiation dermatitis. During the study, digital photos of patients' skin will be taken to assess the amount of dermatitis (redness, blistering, or peeling). Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause side effects. Some common side effects include skin reactions (such as redness, dryness, itching, blistering, or peeling) in the treatment area. It is important to note that the "Spot Delete" technique aims to specifically address the skin reactions, so there might be a potential reduction in this particular risk.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Hedrick, PhD, DABR; Phone Number: 865-862-1600; Email: shedrick@covhlth.com
• Study Contact Backup: Name: Catherine Duke-Taylor, BS; Phone Number: 865-862-1600; Email: cduke@CovHlth.com

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Recruiting
      • Thompson Proton Center
      • Contact: Jessica M Severt, RN, BSN; Phone Number: 865-331-4966; Email: jsevert@covhlth.com
      • Sub-Investigator: Ryan Grover, MD
      • Sub-Investigator: Brion Shin, MD
      • Sub-Investigator: Allen Meek, MD
      • Contact: Catherine Duke-Taylor, BS; Phone Number: 865-331-8216; Email: cduke@CovHlth.com
      • Sub-Investigator: Chester Ramsey, PhD
      • Principal Investigator: Samantha Hedrick, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ≥ 18 years old.
• Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx
• Carcinoma of the neck of unknown primary site origin may be included if p16 positive
• Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases
• Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time
• Previous or concurrent chemotherapy is allowed
• 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:

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• 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.
• Children
• Women who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.	Aim to test the hypothesis that the "Spot Delete" technique in proton therapy reduces radiation dermatitis in head & neck cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. To evaluate this, the investigators will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment.	Weekly Assessments over 10 weeks, 1 month and 6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions.	It is unknown if there is a correlation between the LET lines and the observed skin reactions. To answer this question, 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.	comparisons to be conducted over a 5 year period

Collaborators and Investigators

• Sponsor: Thompson Cancer Survival Center
• Investigators: Principal Investigator: Samantha Hedrick, PhD, DABR, Thompson Proton Center, Director of Medical Physics

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2030

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Head and Neck Neoplasms
• Other Study ID Numbers: 2023-484 INV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes