Clinical trial NCT01576939: Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer
Official title: A Feasibility Study of IMRT (Intensity Modulated Radiotherapy) Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2012-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the feasibility of optimizing the IMRT treatment plan based on dosimeter measurements of mucosal radiation dose adjacent to the dental fillings to reduce such dose to \< 35 Gy without compromising tumor coverage and/or increasing the dose to the remaining oral cavity or nearby parotid glands.

Detailed description: Using radiation dosimeter, we will perform measurement of the doses received by the mucosa adjacent to the dental fillings in patients receiving IMRT for head and neck cancer. If the mucosa dose is estimated to be greater than 35 Gy for the entire radiation course, we will generate and implement a "filling" optimized IMRT plan, provided that this new plan does not compromise tumor coverage or increase dose to the rest of the oral mucosa or parotid glands. Dosimeter will be used to measure the mucosal dose delivered by this new IMRT plan. Patient's mucositis grade, narcotic use and self-reported mouth and throat soreness scores will be recorded and correlated to mucosal dose. We hypothesize that modulation of an IMRT plan to reduce the dose delivered to adjacent normal mucosa surrounding the dental filling can decrease the severity and duration of radiation-related oral mucositis. Here we propose to use thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT plan that is normally delivered in the clinic.

Eligibility criteria: Inclusion Criteria:

* Patients with HNC undergoing radiation therapy +/- chemotherapy at Stanford University
* At least 18 years old
* Metallic filling present
* Planned radiation dose to the tumor \> 60 Gy at 1.8 to 2.2 Gy/fx
* Able to understand and sign a written informed consent document.

Exclusion Criteria:

* Pregnant
* Nursing

Primary outcomes:
measure: Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.
timeFrame: 3 years
measure: Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.
timeFrame: 3 years
Secondary outcomes:
measure: Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use
timeFrame: 3 years
measure: How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose
timeFrame: 3 years
measure: How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?
timeFrame: 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Professor of Radiation Oncology
name: Quynh-Thu Le, MD
role: PRINCIPAL_INVESTIGATOR
References: