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

NCT06183268 | Recruiting FDA Device

• 1 other identifier: 2023-484 INV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• "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 Outcomes (1)

• To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions.

  comparisons to be conducted over a 5 year period

Interventions

Spot Delete RADIATION

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Covenant Health Cancer Center: lead

Study Sites (1)

Thompson Proton Center

Knoxville, Tennessee, 37909, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Samantha Hedrick, PhD, DABR

  Thompson Proton Center, Director of Medical Physics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Hedrick, PhD, DABR

CONTACT

865-862-1600; shedrick@CovHlth.com

Catherine Duke-Taylor, BS

CONTACT

865-862-1600; cduke@CovHlth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: December 13, 2023
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2030
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)