NCT03530735

Brief Summary

This is a feasibility study that will assess the efficacy of using autologous blood to treat moderate to severe dry mouth. Dry mouth has been estimated to affect up to 64.8% of the general population (Navazesh et al., 2009) and many patients that are affected by Sjögren's syndrome or have had radiation therapy to combat head or neck cancer (Navazesh et al., 2009). The blood will be applied to the interior of the mouth by means of a mouthwash. This research poses the first potential curative treatment for dry mouth - all other current dry mouth treatments are either symptomatic or lifestyle-based. Autologous blood has been shown to be effective in treating the epithelial surface of dry eyes. This has been attributed to the analogous growth factors in the blood to that of tears - and potentially in this case, saliva - in healing the oral epithelial surface (Herbst et al., 2004).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 27, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

April 10, 2018

Last Update Submit

July 26, 2018

Conditions

XerostomiaXerostomia Due to RadiotherapyXerostomia Due to Hyposecretion of Salivary Gland

Keywords

Fingerprick Autologous Blood

Outcome Measures

Primary Outcomes (2)

  • Improvement of signs of clinical dry mouth

    To assess improvement of signs of dry mouth using the Challachombe scale for visual identification and quantification of dry mouth

    6 months

  • Improvement of symptoms of Dry Mouth

    To assess improvement of signs of dry mouth using the seven item Xerostomia index.

    6 months

Secondary Outcomes (1)

  • Adherence Self Report Questionnaire to assess patient compliance

    12 months

Study Arms (1)

Fingerprick Autologous Blood (FAB) for Use in Dry Mouth

EXPERIMENTAL

All patients recruited will receive a 10ml saline mouth wash. Half will produce a blood-saline mixture from this mouthwash (preparation details below) and the other half will only use standard saline mouthwash. Each group will use their respective mouthwash 4 times a day for 4 weeks. During the following 4 weeks, participants will use the other mouthwash treatment. In the final 4 weeks, neither group of patients will be using either mouthwash. Patients will be assessed at week 0, 2, 4, 6, 8, 10 and 12. However only clinic visits 0, 4, 8 and 12 will require clinic visits. During weeks 2, 6, and 10 the patients will fill out the questionnaire at home.

Other: Finger-prick Autologous Blood (FAB)

Interventions

Finger-prick Autologous Blood (FAB)OTHER

Patients will be instructed to use FAB therapy by: 1. Hand hygiene with soap and water. Dry, then wipe their fingertip with an alcohol street before leaving to air dry. 2. Use a diabetic lancet to prick their cleaned fingertip. 3. Squeeze 5 drops of blood form their finger into 10ml of saline. 4. Gargle the blood-saline mixture for 5 minutes. 5. Swallow the blood-saline mixture. 6. Repeat this 4 times per day.

Fingerprick Autologous Blood (FAB) for Use in Dry Mouth

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients diagnosed with dry mouth and are on or have refused treatment e.g. spray or mouthwash

You may not qualify if:

  • Patients who do not have capacity to consent
  • Patients with immunodeficiency
  • Infected finger or systemic infection or on systemic antibiotics for infection
  • Patients with active microbial infection, acute herpes simplex, herpes zoster or infected mouth ulcers
  • Pregnant or breast feeding women
  • Fear of needles and unwillingness to carry out repeated finger pricks
  • Patients with frank oral ulceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Navazesh M, Kumar SK. Xerostomia: prevalence, diagnosis, and management. Compend Contin Educ Dent. 2009 Jul-Aug;30(6):326-8, 331-2; quiz 333-4.

    PMID: 19715009BACKGROUND

  • Herbst RS. Review of epidermal growth factor receptor biology. Int J Radiat Oncol Biol Phys. 2004;59(2 Suppl):21-6. doi: 10.1016/j.ijrobp.2003.11.041.

    PMID: 15142631BACKGROUND

  • Than J, Balal S, Wawrzynski J, Nesaratnam N, Saleh GM, Moore J, Patel A, Shah S, Sharma B, Kumar B, Smith J, Sharma A. Fingerprick autologous blood: a novel treatment for dry eye syndrome. Eye (Lond). 2017 Dec;31(12):1655-1663. doi: 10.1038/eye.2017.118. Epub 2017 Jun 16.

    PMID: 28622325BACKGROUND

  • Klenkler B, Sheardown H, Jones L. Growth factors in the tear film: role in tissue maintenance, wound healing, and ocular pathology. Ocul Surf. 2007 Jul;5(3):228-39. doi: 10.1016/s1542-0124(12)70613-4.

    PMID: 17660896BACKGROUND

  • Mogi M, Inagaki H, Kojima K, Minami M, Harada M. Transforming growth factor-alpha in human submandibular gland and saliva. J Immunoassay. 1995 Nov;16(4):379-94. doi: 10.1080/15321819508013569.

    PMID: 8567985BACKGROUND

  • Marti U, Burwen SJ, Jones AL. Biological effects of epidermal growth factor, with emphasis on the gastrointestinal tract and liver: an update. Hepatology. 1989 Jan;9(1):126-38. doi: 10.1002/hep.1840090122.

    PMID: 2642290BACKGROUND

  • Amano O, Matsumoto K, Nakamura T, Iseki S. Expression and localization of hepatocyte growth factor in rat submandibular gland. Growth Factors. 1994;10(2):145-51. doi: 10.3109/08977199409010988.

    PMID: 8068352BACKGROUND

  • Ohashi Y, Motokura M, Kinoshita Y, Mano T, Watanabe H, Kinoshita S, Manabe R, Oshiden K, Yanaihara C. Presence of epidermal growth factor in human tears. Invest Ophthalmol Vis Sci. 1989 Aug;30(8):1879-82.

    PMID: 2788149BACKGROUND

  • Gupta A, Monroy D, Ji Z, Yoshino K, Huang A, Pflugfelder SC. Transforming growth factor beta-1 and beta-2 in human tear fluid. Curr Eye Res. 1996 Jun;15(6):605-14. doi: 10.3109/02713689609008900.

    PMID: 8670763BACKGROUND

  • Geerling G, Sieg P. Transplantation of the major salivary glands. Dev Ophthalmol. 2008;41:255-268. doi: 10.1159/000131094.

    PMID: 18453774BACKGROUND

  • Shirlaw PJ, Khan A. Oral dryness and Sjogren's: an update. Br Dent J. 2017 Nov 10;223(9):649-654. doi: 10.1038/sj.bdj.2017.882.

    PMID: 29123309BACKGROUND

  • Davies AN, Thompson J. Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD003782. doi: 10.1002/14651858.CD003782.pub3.

    PMID: 26436597BACKGROUND

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Anant Sharma, MBBS, FRCOphth

CONTACT

01234355122anant.sharma@bedfordhospital.nhs.uk

Rynda Nitiahpapand, MBBS

CONTACT

01234355122rynda.nitiahpapand@bedfordhospital.nhs.uk

Study Design

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

Study Record Dates

First Submitted

April 10, 2018

First Posted

May 21, 2018

Study Start

September 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 27, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share