NCT00138827

Brief Summary

The purpose of this study is to assess whether Biotene oral care products have a benefit in the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth care regimes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 1999

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 1999

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

December 15, 2005

Status Verified

May 1, 1998

First QC Date

August 29, 2005

Last Update Submit

December 14, 2005

Conditions

Head and Neck Neoplasms

Keywords

RadiotherapyMucositisXerostomia

Outcome Measures

Primary Outcomes (4)

  • Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions

  • Mucositis - dichotomised

  • Xerostomia - dichotomised

  • Pain medications - dichotomised

Secondary Outcomes (3)

  • Oral flora

  • Oral pH

  • Salivary flow

Interventions

Biotene (mouth care)DRUG

Eligibility Criteria

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

You may qualify if:

  • Are undergoing oral or pharyngeal irradiation with a cumulative dose \> 35Gy with at least 1/2 of the salivary tissue contained within the field of treatment.
  • May or may not have undergone surgery.
  • Are available for follow-up questionnaires.
  • Are English speaking or have an easily accessible interpreter.

You may not qualify if:

  • No co-morbidities which may result in dry mouth, for example Sjögren syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Hospital, Cancer Care Centre

Sydney, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMucositisXerostomia

Interventions

BioteneOral Hygiene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPreventive DentistryDentistry

Study Officials

  • Associate Professor Peter H Graham

    St George Hospital, Sydney, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

November 1, 1999

Study Completion

March 1, 2003

Last Updated

December 15, 2005

Record last verified: 1998-05

Locations

AU(1)