Trial Outcomes & Findings for Feasibility of IMRT Modulation to Account for Scattered Radiation From Dental Fillings in Head and Neck Cancer (NCT NCT01576939)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

3 years

Results posted on

2017-06-14

Participant Flow

The study took place at Stanford University. The study started in July 2011 and it ended July 2014.

No pre-assignment details as the patients were recruited and placed directly in the study.

Participant milestones

Participant milestones
Measure	Intensity Modulated Radiotherapy Treatment Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensity Modulated RT Treatment n=30 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Primary Tumor location Pharynx	23 Participants n=5 Participants
Primary Tumor location Oral Cavity	7 Participants n=5 Participants
Tongue dose	30.5 Gy n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The entire cohort was analyzed

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.

Outcome measures

Outcome measures
Measure	Intensity Modulated Radiotherapy Treatment n=30 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment. Dose <30 Gy	34 Days Interval 28.0 to 36.0
Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment. Dose >= 30 Gy	29 Days Interval 21.0 to 35.0

PRIMARY outcome

Timeframe: 3 years

Population: For each subject, both left and right sides were included as two measurements from the same individual.

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.

Outcome measures

Outcome measures
Measure	Intensity Modulated Radiotherapy Treatment n=25 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed. dose < 30 Gy	25.722 Days Interval 14.692 to 36.752
Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed. dose >= 30 Gy	27.917 Days Interval 18.364 to 37.469

SECONDARY outcome

Timeframe: 3 years

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.

Outcome measures

Outcome measures
Measure	Intensity Modulated Radiotherapy Treatment n=30 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use dose < 30 Gy	917.5 mg Interval 232.2 to 1602.8
Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use dose >= 30 Gy	1214.3 mg Interval 552.2 to 1876.3

SECONDARY outcome

Timeframe: 3 years

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).

Outcome measures

Outcome measures
Measure	Intensity Modulated Radiotherapy Treatment n=30 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose dose < 30 Gy	2.908 units on soreness scale Interval 2.011 to 3.805
How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose dose >= 30 Gy	3.689 units on soreness scale Interval 2.832 to 4.546

SECONDARY outcome

Timeframe: 3 years

Population: Only 29 out of the 30 subjects filled out the pain surveys

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).

Outcome measures

Outcome measures
Measure	Intensity Modulated Radiotherapy Treatment n=29 Participants Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose? dose < 30 Gy	2.28 units on pain scale Interval 1.278 to 3.283
How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose? dose >= 30 Gy	3.292 units on pain scale Interval 2.332 to 4.253

Adverse Events

Intensity Modulated Radiotherapy Treatment

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intensity Modulated Radiotherapy Treatment n=30 participants at risk Radiation dose to the tumor is \> 60 Gy at 1.8-2.2 Gy/fx. intensity modulated radiotherapy treatment
Gastrointestinal disorders Mucositis Oral	36.7% 11/30 • Number of events 11 • The adverse events data was collected during the entire study period from July 2011 until July 2014 for a total of 3 years.

Other adverse events

Adverse event data not reported

Additional Information

Quynh Le

Stanford University

Phone: 650-725-0203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place