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Head and Neck CancerNCT01576939

Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer

A study testing Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Intensity Modulated Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2011to Apr 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnant
  • Nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Intensity Modulated Radiation Therapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    We are using thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, "non-filling" optimized IMRT (intensity modulated radiotherapy treatment) plan that is normally delivered in the clinic. If the measured mucosal dose exceeds 35 Gy, we will generate a "filling" optimized IMRT plan to reduce it to < 35 Gy. The new plan will be deemed acceptable and implemented only if it does not (1) compromise the tumor coverage, (2) increase the dose to either the remaining oral cavity or the spared parotid gland(s).

Study groups in NCT01576939
Study groupRoleWhat they receive
IMRT ModulationExperimentalAll patients will undergo a computed tomography (CT) simulation study +/- a positron emission tomography (PET) scan using ≤ 3mm slices for radiation treatment planning. A standard, "non-filling" optimized IMRT (Intensity Modulated Radiation Therapy) plan will be generated and patients will be treated with megavoltage radiation over a course of > 6 weeks with a planned tumor dose of > 60 Gy. A medical doctor will perform weekly mucositis evaluation and grading for the measured site once a week during radiation therapy Modulation of an IMRT plan to reduce the dose to less than 35 Gy delivered to adjacent normal mucosa surrounding the dental filling without compromising normal tissue or tumor doses.
Receives: Radiation: Intensity Modulated Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.

    The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier.

    Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was < grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is < grade 2.

    Measured: 3 years

  2. Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.

    The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved.

    The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis.

    Measured: 3 years

Secondary outcomes (3)

  1. Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use

    The narcotics use was a patient reported measurement that was documented in the medical note in the patient chart. Patient self reported measurements are generally known to be unreliable.

    Measured: 3 years

  2. How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose

    The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMWQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.

    This outcome measures soreness in both the mouth and throat.

    This outcome is not a combination of several sub-scales. This outcome was the response to the single question: "On a scale from 0 to 10, how would you rate your OVERALL MOUTH AND THROAT SORENESS during the past 24 hours?"

    Mouth and throat soreness was measured as a single scale from 0 (no soreness) to 10 (worst soreness possible).

    Measured: 3 years

  3. How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?

    The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMDQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.

    This outcome measures pain in the mouth only.

    This outcome is not a combination of several sub-scales. This outcome was the response to a single question: "On a scale from 0 to 10, what number best describes the MOUTH PAIN that you experienced in the past 24 hours?"

    Mouth pain scale was measured as a single scale from 0 (no pain) to 10 (worst pain imaginable).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576939
Sponsor's protocol ID
IRB-21777
Other IDs
SU-08102011-8266, ENT0032
Status last verified
May 2017
First submitted
23 Sep 2011
Last updated
14 Jun 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intensity Modulated Radiation Therapy in people with Head and Neck Cancer, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01576939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.

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