NCT00332865

Brief Summary

Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H\&N35 questionnaire. Weight loss, duration of tube feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 head-and-neck-cancer

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1 head-and-neck-cancer

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

First Submitted

Initial submission to the registry

June 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

7 years

First QC Date

June 1, 2006

Last Update Submit

June 18, 2013

Conditions

Head and Neck Cancer

Keywords

Head and neck cancerRadiotherapyDysphagiaExerciseDeglutitionRandomized controlled trialQuality of lifeTube feeding

Outcome Measures

Primary Outcomes (1)

  • Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing

    2 mths

Secondary Outcomes (3)

  • Weight

    2 mths

  • Duration of tube feeding

    2 mths

  • Swallowing scale of EORTC HN 35

    2 mths

Interventions

Swallowing ExercisesBEHAVIORAL

Daily exercises

Eligibility Criteria

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

You may qualify if:

  • Head and neck cancer
  • Planned curative radiotherapy
  • Planned irradiation of level II+III lymph nodes \>46 Gy
  • \>=18 y
  • Speaks and reads Danish
  • No previous Surgery to the head and neck area except biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsDeglutition DisordersMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesBehavior

Study Officials

  • Kenneth Jensen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD ph.d.

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

DK(1)