Xerostomia
Conditions
Keywords
Whole Brain Radiation
Brief summary
The purpose of this study is to evaluate the efficacy of parotid sparing in reducing measurable xerostomia (dry mouth) in patients undergoing whole brain radiotherapy. This is primarily a two-arm, single-blind, randomized study of parotid sparing whole brain radiation therapy (WBRT), with a third observational arm of patients who were identified after radiation had already started or who refused randomization but were willing to be followed for quality of life assessment. Qualifying patients who are interested in participating in the trial will be asked to complete an anonymous screening baseline xerostomia questionnaire. If their raw score on this questionnaire meets eligibility criteria, they will be offered enrollment on the study. Patients identified prior to radiation start will be offered enrollment into the interventional randomization arm, with the observation arm offered to those who refuse randomization. Patients identified after radiation has already started, but within 5 days of the first day of radiation, will be offered enrollment into the observational arm. Questionnaires completed by patients who consent to the trial will be assigned patient information (de-anonymized) and serve as their baseline quality of life data. After baseline assessment, subjects will be asked to complete the same questionnaire again at the end of treatment, as well as two weeks, one month, three months, and six months after treatment completion.
Interventions
RADIATIONParotid sparing WBRT
Whole Brain Radiation Therapy with avoidance of the parotid glands
RADIATIONStandard WBRT
Standard Whole Brain Radiation Therapy
Sponsors
University of North Carolina, Chapel Hill
University of Michigan
Wake Forest University Health Sciences
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients to be treated with WBRT using 3-dimensional conformal RT in 10-15 fractions to a total dose of 30-35 Gy for any diagnosis other than elective treatment of potentially subclinical intracranial disease. * No prior radiation that would have exposed the parotids to a significant level of radiation (estimated \>10 Gy mean parotid dose). Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated \<1 Gy) radiation. * Patients enrolling on the observational arm may have started their current course of whole brain radiation therapy within 5 days prior to completing the baseline screening questionnaire and consenting to study. * Greater than or equal to 18 years of age (no upper age limit). * Raw xerostomia score \< 40 / 80 on the initial screening xerostomia questionnaire. This is calculated by adding up the values from questions 1-8. * Initial xerostomia questionnaire and informed consent obtained within the required time frame (≤ 30 days before RT start for interventional arm; ≤ 5 days after RT start for observational arm).
Exclusion criteria
* Patients receiving WBRT without the use of a CT- or MRI-based planning simulation. * Patients receiving WBRT with the use of intensity-modulated radiation therapy. * Patient receiving WBRT as elective treatment of potentially subclinical intracranial disease (e.g., WBRT for prophylactic cranial irradiation of small cell lung cancer). * Patients physically unable to communicate by paper or phone to complete the study survey. * Prisoners. * Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia One Month After Completion of Treatment | Up to 45 days | Between baseline and 1 month after the treatment xerostomia symptoms were assessed, in 2 randomized groups namely Arm A and Arm B. Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes in xerostomia symptoms in each arm were tabulated. Positive values represent increased xerostomia symptoms and negative values represent decreasing xerostomia symptoms and no difference is no change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Relapse | Up to 6 months | The number of subjects with marginal cervical spine relapse in each randomization arm. |
| Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Up to 45 days | Between baseline and 1 month after the treatment xerostomia symptoms were assessed and tabulated based on the whole brain radiotherapy (WBRT) technique. The Standard WBRT Group includes both randomized (Group A) and non-randomized (Group C) subjects who received WBRT. The Parotid Sparing WBRT Group includes subjects who were randomized and received Parotid Sparing WBRT (Group B). Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes were tabulated as: Positive values represent worsened xerostomia symptoms, and both negative values and no change values represent did not worsen. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 05/09/2018 through 02/03/2021 at 3 cancer centers in the United States.
Pre-assignment details
Sixty subjects were included in the study: 56 subjects were randomized into 2 groups: Group A (29 subjects) and Group B (27 subjects), and 4 subjects who started therapy according to physician choice, were included in Group C.
Participants by arm
| Arm | Count |
|---|---|
| Arm A:RandomizedControl Group Subjects received standard whole-brain radiation therapy | 29 |
| Arm B:RandomizedIntervention Group Subjects received standard whole-brain radiation therapy with avoidance of the parotid glands. | 27 |
| Arm C:Observational Arm Subjects enrolled in this arm per their physician's choice, received standard whole-brain radiation therapy. | 4 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 1 | 0 |
| Overall Study | Disease progression | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Arm C:Observational Arm | Arm B:RandomizedIntervention Group | Arm A:RandomizedControl Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 12 Participants | 9 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 15 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 25 Participants | 29 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 22 Participants | 27 Participants | 52 Participants |
| Region of Enrollment United States | 4 participants | 27 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 1 Participants | 17 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Xerostomia One Month After Completion of Treatment
Between baseline and 1 month after the treatment xerostomia symptoms were assessed, in 2 randomized groups namely Arm A and Arm B. Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes in xerostomia symptoms in each arm were tabulated. Positive values represent increased xerostomia symptoms and negative values represent decreasing xerostomia symptoms and no difference is no change.
Time frame: Up to 45 days
Population: Subjects were randomized in 2 randomized groups namely Arm A and Arm B, completed the treatment, and responded to the quality-of-life questionnaire, both at baseline and after 1 month after completion of treatment. Arm C was not included since Arm C is not a randomized arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Arm - Control Group | Xerostomia One Month After Completion of Treatment | Improved: Decreased xerostomia symptoms | 5 Participants |
| Randomized Arm - Control Group | Xerostomia One Month After Completion of Treatment | No Change in xerostomia symptoms | 1 Participants |
| Randomized Arm - Control Group | Xerostomia One Month After Completion of Treatment | Worsened: Increased xerostomia symptoms | 9 Participants |
| Randomized Arm - Intervention Group | Xerostomia One Month After Completion of Treatment | Improved: Decreased xerostomia symptoms | 7 Participants |
| Randomized Arm - Intervention Group | Xerostomia One Month After Completion of Treatment | No Change in xerostomia symptoms | 6 Participants |
| Randomized Arm - Intervention Group | Xerostomia One Month After Completion of Treatment | Worsened: Increased xerostomia symptoms | 5 Participants |
Secondary
Freedom From Relapse
The number of subjects with marginal cervical spine relapse in each randomization arm.
Time frame: Up to 6 months
Population: The subjects completed the treatment and were assessed for the occurrence of marginal relapse.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Arm - Control Group | Freedom From Relapse | Number of subject with marginal relapse | 0 Participants |
| Randomized Arm - Control Group | Freedom From Relapse | Number of subject without marginal relapse | 15 Participants |
| Randomized Arm - Intervention Group | Freedom From Relapse | Number of subject with marginal relapse | 0 Participants |
| Randomized Arm - Intervention Group | Freedom From Relapse | Number of subject without marginal relapse | 14 Participants |
| Arm C : Not- Randomized Arm Observational Arm | Freedom From Relapse | Number of subject with marginal relapse | 0 Participants |
| Arm C : Not- Randomized Arm Observational Arm | Freedom From Relapse | Number of subject without marginal relapse | 1 Participants |
Secondary
Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment
Between baseline and 1 month after the treatment xerostomia symptoms were assessed and tabulated based on the whole brain radiotherapy (WBRT) technique. The Standard WBRT Group includes both randomized (Group A) and non-randomized (Group C) subjects who received WBRT. The Parotid Sparing WBRT Group includes subjects who were randomized and received Parotid Sparing WBRT (Group B). Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes were tabulated as: Positive values represent worsened xerostomia symptoms, and both negative values and no change values represent did not worsen.
Time frame: Up to 45 days
Population: Subjects completed the treatment and responded to the quality-of-life questionnaire both at baseline and one month after the treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Arm - Control Group | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia Worsened | 9 Participants |
| Randomized Arm - Control Group | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia did not worsen | 6 Participants |
| Randomized Arm - Intervention Group | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia Worsened | 5 Participants |
| Randomized Arm - Intervention Group | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia did not worsen | 13 Participants |
| Arm C : Not- Randomized Arm Observational Arm | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia Worsened | 0 Participants |
| Arm C : Not- Randomized Arm Observational Arm | Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment | Xerostomia did not worsen | 1 Participants |