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

Recruiting now · Not applicable

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma

In brief

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 facts

Study ID

NCT06183268

Run by

Covenant Health Cancer Center

People needed

100

Starts

2023-12-13

Expected to finish

2030-01-02

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Thompson Proton Center — Knoxville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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