Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
xerostomia, Robust photon radiotherapy, Margin based radiotherapy
Brief summary
This is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (HN-SQCC). This study will compare the side effects experienced based on the method to plan radiotherapy, Margin Based or Robust.
Detailed description
This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. Intensity-modulated radiation therapy (IMRT) and standard chemotherapy will be used. QOL (quality of life) will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and EORTC QLQ-H&N35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. Xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) LENT/SOMA grading system and the University of Michigan's Xerostomia Questionnaire (XQ). The data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of HN-SQCC.
Interventions
OTHERRobust Radiotherapy planning
Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
OTHERMargin-Based Radiotherapy planning
Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological documentation of Squamous-Cell Carcinoma of the Head and Neck (HN-SQCC) * Older than 21 years of age * Subject is eligible for routine chemo-radiotherapy for treatment of HN-SQCC * Informed consent is obtained * Karnofsky performance of at least 70 points
Exclusion criteria
* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential must agree to refrain from breast feeding and practice adequate contraception * Unable to comply with study procedures * Use of saliva stimulating prescription drugs such as Evoxac or Salagen * Unable to receive standard chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of Xerostomia | Baseline | Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values. |
| Prevalence of Xerostomia | Baseline | Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Margin-Based Radiotherapy Planning This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area | 10 |
| Robust Radiotherapy Planning This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue | 13 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Continuation not in patient best interest | 1 | 0 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Patient opted to be treated elsewhere | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Robust Radiotherapy Planning | Margin-Based Radiotherapy Planning |
|---|---|---|---|
| Age, Continuous | 62.8824 years STANDARD_DEVIATION 10.62783 | 62.8215 years STANDARD_DEVIATION 11.87871 | 62.9615 years STANDARD_DEVIATION 9.37823 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scale (LENT-SOMA) | 1.16 units on a scale STANDARD_DEVIATION 0.501 | 1.17 units on a scale STANDARD_DEVIATION 0.577 | 1.14 units on a scale STANDARD_DEVIATION 0.378 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 10 Participants | 10 Participants |
| Region of Enrollment United States | 23 participants | 13 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 20 Participants | 11 Participants | 9 Participants |
| University of Michigan's Xerostomia Questionnaire (XQ) | 14.7283 score on a scale STANDARD_DEVIATION 20.14139 | 14.1346 score on a scale STANDARD_DEVIATION 17.87095 | 15.5 score on a scale STANDARD_DEVIATION 23.76242 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 1 / 13 |
| other Total, other adverse events | 3 / 10 | 6 / 13 |
| serious Total, serious adverse events | 2 / 10 | 5 / 13 |
Outcome results
Primary
Grade of Xerostomia
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values.
Time frame: Baseline
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Grade of Xerostomia | 1.14 units on a scale | Standard Deviation 0.378 |
| Robust Radiotherapy Planning | Grade of Xerostomia | 1.17 units on a scale | Standard Deviation 0.577 |
Primary
Grade of Xerostomia
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values.
Time frame: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Grade of Xerostomia | 2.00 units on a scale | Standard Deviation 0.894 |
| Robust Radiotherapy Planning | Grade of Xerostomia | 2.91 units on a scale | Standard Deviation 1.136 |
Primary
Grade of Xerostomia
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values.
Time frame: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Grade of Xerostomia | 2.5 units on a scale | Standard Deviation 0.577 |
| Robust Radiotherapy Planning | Grade of Xerostomia | 2.33 units on a scale | Standard Deviation 1.225 |
Primary
Grade of Xerostomia
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values.
Time frame: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Grade of Xerostomia | 1.83 units on a scale | Standard Deviation 0.753 |
| Robust Radiotherapy Planning | Grade of Xerostomia | 2.33 units on a scale | Standard Deviation 1 |
Primary
Grade of Xerostomia
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 occasional dryness through Stage 4 complete dryness, debilitating. Lower stage values indicate a more favorable outcome than higher stage values.
Time frame: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Grade of Xerostomia | 2.00 units on a scale | Standard Deviation 0.707 |
| Robust Radiotherapy Planning | Grade of Xerostomia | 2.38 units on a scale | Standard Deviation 1.188 |
Primary
Prevalence of Xerostomia
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Prevalence of Xerostomia | 15.5 score on a scale | Standard Deviation 23.76242 |
| Robust Radiotherapy Planning | Prevalence of Xerostomia | 14.1346 score on a scale | Standard Deviation 17.87095 |
Primary
Prevalence of Xerostomia
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Time frame: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Prevalence of Xerostomia | 45.625 score on a scale | Standard Deviation 30.68744 |
| Robust Radiotherapy Planning | Prevalence of Xerostomia | 64.3182 score on a scale | Standard Deviation 15.0142 |
Primary
Prevalence of Xerostomia
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Time frame: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Prevalence of Xerostomia | 60.0000 score on a scale | Standard Deviation 23.68412 |
| Robust Radiotherapy Planning | Prevalence of Xerostomia | 54.8611 score on a scale | Standard Deviation 29.91815 |
Primary
Prevalence of Xerostomia
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Time frame: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Prevalence of Xerostomia | 31.6667 score on a scale | Standard Deviation 31.38139 |
| Robust Radiotherapy Planning | Prevalence of Xerostomia | 54.0278 score on a scale | Standard Deviation 24.57274 |
Primary
Prevalence of Xerostomia
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Time frame: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
Population: There were missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Margin-Based Radiotherapy Planning | Prevalence of Xerostomia | 50.75 score on a scale | Standard Deviation 30.29284 |
| Robust Radiotherapy Planning | Prevalence of Xerostomia | 38.4375 score on a scale | Standard Deviation 26.69897 |