XerostomiaNCT04007081

Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

A study testing Bone Marrow Aspiration, Ultrasound Imaging of Salivary Glands and Salivary Assay in people with Xerostomia and Head and Neck Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Xerostomia, Head and Neck Cancer
What is being tested?: Bone Marrow Aspiration, Ultrasound Imaging of Salivary Glands and Salivary Assay
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 18 Oct 2019to 10 Mar 2021
Phase: Interventional
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 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Salivary gland disease (e.g., sialolithiasis)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: Salivary Gland Autotransplantation of Marrow Mesenchymal Stromal Cells for Treatment of Radiation-induced Xerostomia - FDA IND (Investigational New Drug) Enabling Studies

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.

Read the 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

Conditions: Xerostomia, Head and Neck Cancer
Being tested: Bone Marrow Aspiration, Ultrasound Imaging of Salivary Glands, Salivary Assay, Quality of Life Instruments
Keywords: Dry Mouth, MSC, mesenchymal stem cells, adult stem cells, head and neck cancer, salivary gland, radiation, HNC
Medical subject headings: Xerostomia, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone Marrow AspirationProcedure or surgery
Also called Bone Marrow Collection
collection of approximately 40 mL of bone marrow aspirate
Ultrasound Imaging of Salivary GlandsDiagnostic test
Salivary gland size will be measured by ultrasound.
Salivary AssayOther
Also called sialometry
Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions
Quality of Life InstrumentsOther
Participants will self-assess with the following Quality of Life (QoL) surveys: University of Michigan Xerostomia related quality of life scale (XeQOL), the MD Anderson Dysphagia Index (MDADI), and the VAS xerostomia questionnaire.

Study groups in NCT04007081
Study group	Role	What they receive
Participants with Xerostomia	Experimental	Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration Receives: Procedure: Bone Marrow Aspiration; Diagnostic Test: Ultrasound Imaging of Salivary Glands; Other: Salivary Assay; Other: Quality of Life Instruments

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two 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.
Measured: Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks

Secondary outcomes (6)

Change in participant QoL: XeQOL
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.
Measured: baseline and up to 6 months
Change in participant QoL: MDADI
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.
Measured: baseline and up to 6 months
Change in participant QoL: VAS
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.
Measured: baseline and up to 6 months
Change in participant Salivary Function: Unstimulated
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.
Measured: baseline and up to 6 months
Change in participant Salivary Function: Stimulated
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.
Measured: baseline and up to 6 months
Change in participant Salivary Gland Size
The size of salivary glands will be measured via ultrasound at baseline and up to 6 months on study.
Measured: baseline and up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201910 Mar 2021

First posted5 Jul 2019
Study start18 Oct 2019
Primary completion10 Mar 2021
Study completion10 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for XerostomiaStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
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 N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04007081
Sponsor's protocol ID: UW19009
Other IDs: 2019-0497, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, A533300, Protocol Version 7/24/2020
Status last verified: Mar 2021
First submitted: 26 Jun 2019
Last updated: 24 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy

All Xerostomia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Salivary Gland Autotransplantation of Marrow Mesenchymal Stromal Cells for Treatment of Radiation-induced Xerostomia - FDA IND (Investigational New Drug) Enabling Studies
ClinicalTrials.gov ID: NCT04007081
Acronym / sponsor ID: UW19009
Conditions: Xerostomia, Head and Neck Cancer
Keywords: Dry Mouth, MSC, mesenchymal stem cells, adult stem cells, head and neck cancer, salivary gland, radiation, HNC
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 18 Oct 2019 (actual)
Primary completion: 10 Mar 2021 (actual)
Study completion: 10 Mar 2021 (actual)
First posted: 5 Jul 2019 (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.

Participants can expect to be on study for up to 6 months.

Detailed description

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Participants with Xerostomia	Experimental	Procedure: Bone Marrow Aspiration, Diagnostic Test: Ultrasound Imaging of Salivary Glands, Other: Salivary Assay, Other: Quality of Life InstrumentsSalivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Salivary gland disease (e.g., sialolithiasis)

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
Bone Marrow AspirationAlso: Bone Marrow Collectioncollection of approximately 40 mL of bone marrow aspirate	Procedure or surgery	Participants with Xerostomia
Ultrasound Imaging of Salivary GlandsSalivary gland size will be measured by ultrasound.	Diagnostic test	Participants with Xerostomia
Salivary AssayAlso: sialometryWhole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions	Other	Participants with Xerostomia
Quality of Life InstrumentsParticipants will self-assess with the following Quality of Life (QoL) surveys: University of Michigan Xerostomia related quality of life scale (XeQOL), the MD Anderson Dysphagia Index (MDADI), and the VAS xerostomia questionnaire.	Other	Participants with Xerostomia

Primary outcome

Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks
Time frame: 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.

6 secondary outcomes

Change in participant QoL: XeQOL
Time frame: baseline and up to 6 months
Change in participant QoL: MDADI
Time frame: baseline and up to 6 months
Change in participant QoL: VAS
Time frame: baseline and up to 6 months
Change in participant Salivary Function: Unstimulated
Time frame: baseline and up to 6 months
Change in participant Salivary Function: Stimulated
Time frame: baseline and up to 6 months
Change in participant Salivary Gland Size
Time frame: baseline and up to 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Xerostomia

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy

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.

Randall Kimple, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 1 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: finished, as of the sponsor's last update on 24 Mar 2021. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks (time frame: Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04007081.

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 24 Mar 2021.