Evaluating skin reactions in head and neck cancer patients receiving proton therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines skin reactions, known as radiation dermatitis, in patients with head and neck cancer undergoing pencil beam scanning (PBS) proton therapy. Researchers will implement a technique called 'Spot Delete' to potentially reduce these skin reactions. A computer model will be utilized to analyze the relationship between the energy of the proton beam and the occurrence of skin reactions. The study will involve creating individualized treatment plans based on CT scans and will document skin reactions through digital photos and patient questionnaires.

Why it matters

Who can join: the full rules

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.

Where it's running

• Thompson Proton Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Samantha Hedrick, PhD, DABR — Thompson Proton Center, Director of Medical Physics
• Study coordinator: Samantha Hedrick, PhD, DABR
• Email: shedrick@CovHlth.com
• Phone: 865-862-1600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.