Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

NCT04007081 | Completed DMC

• 5 other identifiers: UW190092019-0497SMPH/HUMAN ONCOLOGY/HUMAN ONCOA533300Protocol Version 7/24/2020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Head and Neck Cancer

Keywords

Dry Mouth; MSC; mesenchymal stem cells; adult stem cells; head and neck cancer; salivary gland; radiation; HNC

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks

Secondary Outcomes (6)

• Change in participant QoL: XeQOL

  baseline and up to 6 months

• Change in participant QoL: MDADI

  baseline and up to 6 months

• Change in participant QoL: VAS

  baseline and up to 6 months

• Change in participant Salivary Function: Unstimulated

  baseline and up to 6 months

• Change in participant Salivary Function: Stimulated

  baseline and up to 6 months

Other Outcomes (2)

• Compare Secretome Profile of MSCs Between Participant Groups: ELISA

  up to 6 months

• Compare Secretome Profile of MSCs Between Participant Groups: Western Blot

  up to 6 months

Study Arms (1)

Participants with Xerostomia

EXPERIMENTAL

Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration

Procedure: Bone Marrow Aspiration; Diagnostic Test: Ultrasound Imaging of Salivary Glands; Other: Salivary Assay; Other: Quality of Life Instruments

Interventions

Bone Marrow Aspiration PROCEDURE

collection of approximately 40 mL of bone marrow aspirate

Also known as: Bone Marrow Collection

Participants with Xerostomia

Ultrasound Imaging of Salivary Glands DIAGNOSTIC_TEST

Salivary gland size will be measured by ultrasound.

Participants with Xerostomia

Salivary Assay OTHER

Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions

Also known as: sialometry

Participants with Xerostomia

Quality of Life Instruments OTHER

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.

Participants with Xerostomia

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No history of radiation to the salivary glands
• Willing and able to give informed consent

You may not qualify if:

• Salivary gland disease (e.g., sialolithiasis)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Xerostomia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Randall Kimple, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: October 18, 2019
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)