Swallow Exercise as Prophylaxis of Dysphagia After Radiot... | NCT00332865

Studies
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

NCT00332865

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Head and Neck Cancer

Interventions

Swallowing Exercises

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Swallowing Exercises	Behavioral	Daily exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective swallowing using videofluoroscopy and endoscopic evaluation of swallowing		2 mths

Secondary Outcomes

Measure	Description	Time Frame
Weight		2 mths
Duration of tube feeding		2 mths
Swallowing scale of EORTC HN 35

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Jensen, MD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D003680	Deglutition Disorders
D009043	Motor Activity

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided