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Proton Therapy for Head and Neck Cancer: Reducing Skin Reactions

This study is looking at ways to reduce skin reactions (radiation dermatitis) in people with head and neck cancer who are receiving proton therapy. Researchers are testing a technique called "Spot Delete" during pencil beam scanning (PBS) proton therapy. This method aims to prevent the proton beam from stopping in the skin, which might lower the risk of skin irritation. They will also use computer models to understand how the proton beam's energy affects skin reactions. You may be able to join if you are 18 or older and have biopsy-proven squamous cell carcinoma of the head and neck. The study will measure how well "Spot Delete" reduces skin reactions over 10 weeks, and then at 1 and 6 months after treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. The study does not specify a phase.
What's involved
You will have weekly assessments for 10 weeks during treatment, and then follow-up assessments at 1 month and 6 months after treatment. Digital photos of your skin will be taken, and you will complete a self-report questionnaire.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06183268

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

Recruiting
NAAges 18+InterventionalSupportive care
Covenant Health Cancer Center
~100 participants
Updated 2025-04-08 on ClinicalTrials.gov
What's tested:Spot Delete

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
"Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.
Measured over Weekly Assessments over 10 weeks, 1 month and 6 months post treatment

Conditions

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

Explore related trials

Head and Neck Squamous Cell CarcinomaMalignant Head and Neck NeoplasmCDKN2A wt Allele

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Samantha Hedrick, PhD, DABR · PRINCIPAL_INVESTIGATOR · Thompson Proton Center, Director of Medical Physics

Who to contact

Samantha Hedrick, PhD, DABR
[email protected]
865-862-1600
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    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.