Clinical trial NCT06183268: Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy
Official title: Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Head and Neck Carcinoma
Lead sponsor: Thompson Cancer Survival Center
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to increase skin dose and thus risk and magnitude of radiation dermatitis. During the study, digital photos of patients' skin will be taken to assess the amount of dermatitis (redness, blistering, or peeling). Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause side effects. Some common side effects include skin reactions (such as redness, dryness, itching, blistering, or peeling) in the treatment area. It is important to note that the "Spot Delete" technique aims to specifically address the skin reactions, so there might be a potential reduction in this particular risk.

Eligibility 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.

Primary outcomes:
measure: "Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.
timeFrame: Weekly Assessments over 10 weeks, 1 month and 6 months post treatment
Secondary outcomes:
measure: To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions.
timeFrame: comparisons to be conducted over a 5 year period
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Thompson Proton Center
state: Tennessee
Study officials:
affiliation: Thompson Proton Center, Director of Medical Physics
name: Samantha Hedrick, PhD, DABR
role: PRINCIPAL_INVESTIGATOR
References: