Prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. Subjects receiving study treatment will have 6 months of study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
Usual care will include over-the-counter and prescription methods to treat xerostomia.
Midwestern Regional Medical Center
Zion, Illinois, United States
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)
Reported Adverse Events graded according to CTCAE guidelines will be recorded starting at or after the time of injection and at or before 72 hours post injection.
Time frame: 72 hours
Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines)
Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be recorded starting on Day 0 (day of SVF injection) and ending at 12 months.
Time frame: Months 3, 6 and 12 after Day 0 (date of injection)
Unstimulated Saliva Production
Rate of saliva production over a 5-minute period. (g/minute)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Stimulated Saliva Production
Rate of saliva production while chewing gum over a 5-minute period. (g/minute)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire- "How severe is your dry mouth problem?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal; 2 = somewhat more complaints than before radiation therapy; 3 = considerable more complaints than before radiation therapy; and 4 = Permanent complaints of a very dry mouth)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air)
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Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air in case of wind and cold)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In air-conditioned spaces)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth during daytime)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth at nighttime)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Always dry mouth night and day)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially bother of the dry mouth during meals)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?"
Number of events as reported by patient (Number)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal, watery fluid; 2 = Normal watery but too little volume; 3 = Sticky saliva; and 4 = No saliva at all)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with speech; 3 = Frequently speech problems; 4 = always difficulties with speech; and 5= always major speech problems)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Occasionally; 3 = Frequently; 4 = Always; and 5= Even have to interrupt speaking to take a sip of water)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with swallowing; 3 = Frequently problems with swallowing; 4 = Always swallowing difficulties; and 5 = Swallowing is seriously impaired because of the dry mouth problem)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No change in chewing capability; 2 = Some difficulty with chewing; 3 = Frequently difficulties with chewing; 4 = Always difficulties with chewing; 5 = Chewing is seriously hampered because of the dry mouth problem)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No never; 2 = Sometimes, depending on the quality of the food; 3 = Frequently; more often than before radiation therapy; and 4 = Always need to take a sip of water/ fluid with every bite of food)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; 2 = Minor changes, such as avoiding some products; 3 = Can eat only mashed food; 4 = Can eat only liquid food; and 5= Tube feeding)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Sometimes, depending on the weather and environmental circumstances; 3 = Frequently; and 4 = Always, day and night)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; normal taste sensation; 2 = Some reduction in taste discrimination and sensation; 3 = Considerable change in taste; 4 = No taste sensation at all; and 5 = Always a bad taste in the mouth)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?"
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?"
Mean score calculated from patient-reported survey (Likert Scale; 1 = never; 2 = Occasionally; 3 = Frequently; and 4 = Very often)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index
Overall Xerostomia Index is calculated from the first three questions of the Questionnaire \[I = (Q1 x 15.8) + (Q2 x 8.5) + (Q3 x 5.9) - 33.2; where Qn = score of that question.\]
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning
Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort
Mean score calculated from patient-reported survey (Likert Scale; 0=No Pain to 4=Worst Pain)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning
Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning
Mean score between Baseline and 3 months calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey
Mean score calculated from patient-reported survey (Likert Scale; 1=Best Functioning to 4=Worst Functioning)
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline