Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia
- Conditions
- XerostomiaHead and Neck Cancer
- Interventions
- Procedure: Bone Marrow AspirationDiagnostic Test: Ultrasound Imaging of Salivary GlandsOther: Salivary AssayOther: Quality of Life Instruments
- Registration Number
- NCT04007081
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent.
The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life.
Participants can expect to be on study for up to 6 months.
- Detailed Description
This feasibility study will analyze the salivary composition, salivary viscoelasticity, salivary gland US, and QoL surveys of participants without head and neck cancer (HNC) to determine standard values. The investigators will then compare this to the salivary composition and viscoelasticity of participants with treated HNC.
Additionally, the investigators will examine the paracrine factors of marrow MSCs in order to prove a hypothesis that paracine factors constitutively expressed by marrow MSCs \[Wnts, fibroblast growth factors (FGFs), GDNF and others\] will directly influence the biology of dormant salivary gland stem cells following intraglandular transplantation and allow for functional recovery following RT.
Primary Objective
* To determine the feasibility of in vitro expansion of marrow-derived MSCs from HNC patients to \>50 million cells.
Secondary Objectives
* To assess the stability of salivary function in HNC patients using quality-of-life (QoL) questionnaires and salivary composition analysis.
* To assess the stability of salivary gland size as measured by ultrasound.
Correlative Objectives
* To compare assess the secretome profile of MSCs from HNC patients treated with radiation or, chemoradiation, or previously untreated.
* To compare the salivary composition, viscoelasticity, salivary gland ultrasound, and QoL of HNC patients to non-HNC patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
-
Participants ≥2 years from completion of chemoradiation therapy or radiation therapy (N=6) with subjective complaint of xerostomia or with no diagnosis of HNC (N=5)
-
Karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia
-
Not pregnant
-
Willing and able to give informed consent
-
non-HNC participants only need to meet the following applicable inclusion criteria
- No history of radiation to the salivary glands
- Willing and able to give informed consent
- Salivary gland disease (e.g., sialolithiasis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with Xerostomia Bone Marrow Aspiration Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration Participants with Xerostomia Ultrasound Imaging of Salivary Glands Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration Participants with Xerostomia Salivary Assay Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration Participants with Xerostomia Quality of Life Instruments Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration
- Primary Outcome Measures
Name Time Method Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks The feasibility of in vitro expansion of MSCs derived from marrow aspirates collected from participants will be determined by if they can be culture expanded for up to two weeks to generate \>50 million MSCs per donor. Feasibility will reported as the number of participants whose marrow-derived MSCs can be expanded in vitro to \> 50 million cells within two weeks.
- Secondary Outcome Measures
Name Time Method Change in participant QoL: XeQOL baseline and up to 6 months The University of Michigan Xerostomia related quality of life scale (XeQOL) is a 15-item questionnaire about how a participants oral health affects their life. Each item is scored from 1-5 either 'not at all', 'a little', 'somewhat', 'quite a bit', or 'very much' for a total score of 15-75. Higher scores represent greater degree of symptoms.
Change in participant Salivary Function: Unstimulated baseline and up to 6 months Unstimulated saliva production will be measured at two time points by the passive drool method over a 5-minute time frame. Participants will allow saliva to pool in the mouth and, then, with head tilted forward, gently guide saliva into a saliva collection aid attached to a cryovial. Difference in weight of the cryovial empty and after the test will represent the amount of saliva produced.
Change in participant QoL: VAS baseline and up to 6 months The Visual Analogue Scale (VAS) - xerostomia questionnaire is an 8-item questionnaire about how a participant perceives their dry mouth. Each item is visually scored on a sliding scale (100mm in length) between two extremes (Q1 and Q2 from 'not difficult at all' to 'very difficult', Q3 from 'A lot' to 'None', Q4-Q7 from 'Not Dry at All' to 'Very Dry', and Q8 from 'Not Thirsty at All' to 'Very Thirsty'. The participant places a line on the scale to mark their answer. Change between various time points can be determined based on measured distance along the scale for each answer.
Change in participant Salivary Gland Size baseline and up to 6 months The size of salivary glands will be measured via ultrasound at baseline and up to 6 months on study.
Change in participant QoL: MDADI baseline and up to 6 months The MD Anderson Dysphagia Inventory (MDADI) is a 20-item questionnaire about how a participants perceive their swallowing ability. Each item is scored from 'strongly agree', 'agree', 'no opinion', 'disagree', or 'strongly disagree'. One question provides a 'global score between 1-5 where 1 is extremely low functioning and 5 is high functioning. The remaining 19 questions measure a composite score from 20-100 where higher scores represent higher degree of function.
Change in participant Salivary Function: Stimulated baseline and up to 6 months Stimulated saliva production will be measured at two time points by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total. Difference in weight of the cryovial empty and after the test will represent the amount of saliva produced.
Trial Locations
- Locations (1)
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States