NCT04608773

Brief Summary

To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck. To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

October 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

October 18, 2020

Results QC Date

November 15, 2023

Last Update Submit

January 9, 2024

Conditions

XerostomiaHead and Neck CancerXerostomia Following Radiotherapy

Keywords

Mouth Spray

Outcome Measures

Primary Outcomes (1)

  • Oral Dryness

    at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"

    2 week trial period

Secondary Outcomes (6)

  • Sleeping Difficulty Due to Oral Dryness

    2 week trial

  • Speaking Difficulty Due to Oral Dryness

    2 week trial

  • Taste Alteration/Impairment Due to Oral Dryness

    2 week trial

  • Swallowing and Chewing Difficulty Due to Oral Dryness

    2 week trial

  • Saliva PH

    2 week trial

  • +1 more secondary outcomes

Study Arms (2)

Biotene Spray, followed by Refresh Spray

OTHER

The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)

Other: Remineralizing Extreme Dry Mouth Spray with XylitolDevice: Alcohol-Free Moisturizing Dry Mouth Spray

Refresh Spray, followed by Biotene Spray

OTHER

The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)

Other: Remineralizing Extreme Dry Mouth Spray with XylitolDevice: Alcohol-Free Moisturizing Dry Mouth Spray

Interventions

Remineralizing Extreme Dry Mouth Spray with XylitolOTHER

oral hydrating spray

Also known as: Refresh Oral Hydrating Spray
Biotene Spray, followed by Refresh SprayRefresh Spray, followed by Biotene Spray
Alcohol-Free Moisturizing Dry Mouth SprayDEVICE

oral hydrating spray

Also known as: Biotene
Biotene Spray, followed by Refresh SprayRefresh Spray, followed by Biotene Spray

Eligibility Criteria

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

You may qualify if:

  • biopsy-proven oral cavity, oropharynx, larynx, and hypopharynx carcinoma
  • who received primary radiation with curative intent (\>50 Gray in 20 fractions)
  • radiation treatment completed greater than 6 months ago
  • who endorse xerostomia

You may not qualify if:

  • evidence of metastasis or recurrent disease
  • Current use of pilocarpine, antidepressants, anticholinergic drugs, or any other medication that has an effect on salivation
  • those who have documented medical conditions associated with xerostomia such as Sjogren's Syndrome
  • those who use oral inhalants for the treatment of respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (3)

  • Epstein JB, Emerton S, Le ND, Stevenson-Moore P. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol. 1999 Mar;35(2):132-7. doi: 10.1016/s1368-8375(98)00109-2.

    PMID: 10435146BACKGROUND

  • Warde P, Kroll B, O'Sullivan B, Aslanidis J, Tew-George E, Waldron J, Maxymiw W, Liu FF, Payne D, Cummings B. A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. Support Care Cancer. 2000 May;8(3):203-8. doi: 10.1007/s005200050286.

    PMID: 10789961BACKGROUND

  • Eisbruch A, Rhodus N, Rosenthal D, Murphy B, Rasch C, Sonis S, Scarantino C, Brizel D. How should we measure and report radiotherapy-induced xerostomia? Semin Radiat Oncol. 2003 Jul;13(3):226-34. doi: 10.1016/S1053-4296(03)00033-X.

    PMID: 12903012BACKGROUND

MeSH Terms

Conditions

XerostomiaHead and Neck Neoplasms

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Limitations and Caveats

There may be a degree of attrition bias, our modified intention-to-treat design, in which 13 patients had to be reassigned to group 1 from group 2, may have also added bias; we found no evidence of a sequence effect. The treatment effect of each spray was calculated in reference to use of water, which is known to improve oral dryness so the magnitude of the treatment effect may be underestimated, however, we would expect both products to be affected equally.

Results Point of Contact

Title
Anne Fisher
Organization
University of Pittsburgh
amf91@pitt.edu
4126479665

Study Officials

  • Jonas T Johnson, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Both subjects and clinicians will be blinded to Mouth Spray A and Mouth Spray B.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 29, 2020

Study Start

January 14, 2021

Primary Completion

November 15, 2022

Study Completion

June 30, 2023

Last Updated

February 1, 2024

Results First Posted

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)