NCT04337853

Brief Summary

Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

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

March 9, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

April 5, 2020

Last Update Submit

November 1, 2023

Conditions

Tongue Cancer

Keywords

RadiotherapyHead and neck cancerIntraoral stent

Outcome Measures

Primary Outcomes (1)

  • Reduction in mean dose to the hard palate

    Mann-Whitney U test.

    At the end of radiotherapy (5-6 weeks)

Secondary Outcomes (3)

  • Reduction in mean dose to the soft palate

    At the end of radiotherapy (5-6 weeks)

  • Reduction in acute mucositis in the hard palate

    At the end of radiotherapy (5-6 weeks)

  • Reduction in acute mucositis in the soft palate

    At the end of radiotherapy (5-6 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

N=6

Device: Intraoral stent

Control group

ACTIVE COMPARATOR

N=7

Other: No intraoral stent

Interventions

Intraoral stentDEVICE

Radiotherapy with intraoral stent

Intervention group
No intraoral stentOTHER

Radiotherapy without intraoral stent

Control group

Eligibility Criteria

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

You may qualify if:

  • Patients with tongue cancer
  • Curatively intended radiotherapy requiring a total dose of 50-70 Gy
  • Age \>18 years
  • Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Links

MeSH Terms

Conditions

Tongue NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Study Officials

  • Einar Dale, MD PhD

    Oslo University Hospital, Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 8, 2020

Study Start

March 9, 2018

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)