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

NCT ID: NCT06183268

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2030-01-02

Brief Summary

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.

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.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Spot Delete

The treatments plans will utilize the scripted spot delete method to remove spots from the skin rind. To ensure all relevant skin spots are removed, the "SkinSpots" structure will be a 0.5 cm rind extending inward from the skin contour within 5 cm of the CTV. Spots will be removed from this structure and optimization will continue. Optimization objectives will be utilized to spare the skin rind structure during treatment planning, in addition to deleting spots.

Intervention Type: RADIATION

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 ≥ 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thompson Cancer Survival Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samantha Hedrick, PhD, DABR

Role: PRINCIPAL_INVESTIGATOR

Thompson Proton Center, Director of Medical Physics

Locations

Thompson Proton Center

Knoxville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Hedrick, PhD, DABR

Role: CONTACT

shedrick@CovHlth.com

865-862-1600

Catherine Duke-Taylor, BS

Role: CONTACT

cduke@CovHlth.com

865-862-1600

Facility Contacts

Catherine Duke-Taylor, BS

Role: primary

cduke@CovHlth.com

865-331-8216

Jessica M Severt, RN, BSN

Role: backup

jsevert@covhlth.com

865-331-4966

Other Identifiers

2023-484 INV

Identifier Type: -

Identifier Source: org_study_id