Menu
Recruiting NCT06183268

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

No phase Interventional Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spot Delete.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy

Overview

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.

Interventions

  • Radiation Spot Delete
    The treatments plans will utilize the scripted spot delete method to remove spots from the skin rind. To ensure all relevant skin spots are removed, the "SkinSpots" structure will be a 0.5 cm rind extending inward from the skin contour within 5 cm of the CTV. Spots will be removed from this structure and optimization will continue. Optimization objectives will be utilized to spare the skin rind structure during treatment planning, in addition to deleting spots.

Primary outcome measures

  • "Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients. [Time frame: Weekly Assessments over 10 weeks, 1 month and 6 months post treatment]
Secondary outcome measures (1)
  • To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. [Time frame: comparisons to be conducted over a 5 year period]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Thompson Proton Center — Knoxville

Identifiers

NCT: NCT06183268 · 2023-484 INV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗