Evaluating skin reactions in head and neck cancer patients receiving proton therapy
Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy
This study is testing a new way to reduce skin reactions in head and neck cancer patients getting proton therapy by using a special technique and personalized treatment plans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Covenant Health Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06183268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven squamous cell carcinoma in specified head and neck regions.
Not a fit: Patients with prior radiotherapy to the treatment area or serious health conditions affecting skin in the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced skin toxicity for patients receiving proton therapy for head and neck cancer.
How similar studies have performed: While the approach of using PBS proton therapy is established, the specific 'Spot Delete' technique is novel and has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Knoxville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.