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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Covenant Health Cancer Center
Study ID
NCT06183268
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 13, 2023
Status verified
Apr 2025
Primary completion
Jan 2, 2028
Completion
Jan 2, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Primary Outcome Measure

"Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients. [ Time Frame: Weekly Assessments over 10 weeks, 1 month and 6 months post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thompson Proton CenterKnoxvilleTennessee37909
Catherine Duke-Taylor, BS
[email protected]
865-331-8216
Jessica M Severt, RN, BSN
[email protected]
865-331-4966
Ryan Grover, MD (SUB_INVESTIGATOR)
Brion Shin, MD (SUB_INVESTIGATOR)
Allen Meek, MD (SUB_INVESTIGATOR)
Chester Ramsey, PhD (SUB_INVESTIGATOR)
Samantha Hedrick, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Knoxville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Thompson Proton Center· Knoxville, TN

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