Xerostomia Due to Radiotherapy (Disorder)Phase 1/2NCT03061110
Stromal Vascular Fraction for Treatment of Xerostomia
A Phase 1/2 study testing Stromal Vascular Fraction in people with Xerostomia Due to Radiotherapy (Disorder), run by Midwestern Regional Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Xerostomia Due to Radiotherapy (Disorder)
- What is being tested?
- Stromal Vascular Fraction
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female subjects are both eligible
- Subjects must be 21 years of age or older
- History of treated Head and Neck Cancer, no evidence of active cancer at the time of the study
- Original tumor not located adjacent to the parotid or sub-mandibular glands
- Diagnosis of radiation-induced xerostomia
- study is fully explained
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- Females of child bearing potential agree to use acceptable methods of contraception through 6 month study follow-up.
- No current malignancy or history of previous malignancy within the last five years, other than the head and neck cancer, with the exception of adequately treated non-abdominal, non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin)
- Willing to undergo a minor surgical procedure (small-volume liposuction, totaling approximately 60-120cc) and a single treatment of an injection of approximately 30ml of autologous Stromal Vascular Fraction taking approximately 10 minutes
- Abdominal area amenable to liposuction of at least 60-120cc of adipose tissue based on Investigator(s) examination
- Willing to be available for all baseline, treatment and follow-up examinations required by protocol
- Willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by Investigator
Who cannot join
- Patients taking immunosuppressive therapy in the prior 3 months
- Autoimmune disorders
- Patients who are pregnant or currently breast-feeding children
- Patients participating in a study of an experimental drug or medical device within 60 days of study entry
- Uncontrolled hypertension
- Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening
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- Hemoglobin A1c > 8% within 8 weeks prior to study treatment
- Current use of steroids or immunosuppressant therapies
- Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results
- History of Sjogren's Syndrome or related autoimmune disease.
- Taking medication for which xerostomia is a known major side effect
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
Official title: Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients
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.
- Being tested
- Stromal Vascular Fraction, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vascular FractionBiological
Also called Adipose-Derived Stem Cells
Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
Usual CareOther
Also called Standard of Care
Usual care will include over-the-counter and prescription methods to treat xerostomia.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Subjects in the Usual Care arm will receive typical therapies to manage the symptoms of dry mouth including but not limited to: chewing gum, sucking sugar-free candy, sipping water, mouth rinses and over-the-counter artificial saliva preparations. Receives: Other: Usual Care |
| Stromal Vascular Fraction | Experimental | Subjects in the Stromal Vascular Fraction arm will receive single injections into each of the six (6) peri-oral salivary glands (parotid, submandibular, sublingual). Receives: Biological: Stromal Vascular Fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (31)
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Nov 2018 (estimated)
- Primary completion28 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Internal funding not awarded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to Radiotherapy (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to usual care (palliation of symptoms) or injection of stromal vascular fraction.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Ray, MD, Midwestern Regional Medical Center
- Investigators
- Stephen Ray, MD, Principal investigator, Midwestern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061110
- Sponsor's protocol ID
- MZ2017003
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT03061110
- Acronym / sponsor ID
- MZ2017003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal funding not awarded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Midwestern Regional Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 28 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to usual care (palliation of symptoms) or injection of stromal vascular fraction.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareSubjects in the Usual Care arm will receive typical therapies to manage the symptoms of dry mouth including but not limited to: chewing gum, sucking sugar-free candy, sipping water, mouth rinses and over-the-counter artificial saliva preparations. |
| Stromal Vascular Fraction | Experimental | Biological: Stromal Vascular FractionSubjects in the Stromal Vascular Fraction arm will receive single injections into each of the six (6) peri-oral salivary glands (parotid, submandibular, sublingual). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and Female subjects are both eligible
- Subjects must be 21 years of age or older
- History of treated Head and Neck Cancer, no evidence of active cancer at the time of the study
- Original tumor not located adjacent to the parotid or sub-mandibular glands
- Diagnosis of radiation-induced xerostomia
Key exclusion criteria (11 listed)
- Patients taking immunosuppressive therapy in the prior 3 months
- Autoimmune disorders
- Patients who are pregnant or currently breast-feeding children
- Patients participating in a study of an experimental drug or medical device within 60 days of study entry
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal Vascular FractionAlso: Adipose-Derived Stem CellsStromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device. | Biological | Stromal Vascular Fraction |
| Usual CareAlso: Standard of CareUsual care will include over-the-counter and prescription methods to treat xerostomia. | Other | Usual Care |
Primary outcome
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)
Time frame: 72 hours
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.
31 secondary outcomes
Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines)
Time frame: Months 3, 6 and 12 after Day 0 (date of injection)
Unstimulated Saliva Production
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Stimulated Saliva Production
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?"
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)
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)
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)
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)
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)
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)
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)
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index
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
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
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
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
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
Time frame: Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Xerostomia Due to Radiotherapy (Disorder)
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Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Ray, MD principal investigator
Midwestern Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stromal Vascular Fraction in people with Xerostomia Due to Radiotherapy (Disorder), run by Midwestern Regional Medical Center 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 12 inclusion and 11 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: withdrawn, as of the sponsor's last update on 30 Apr 2018. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2018.