Condition category
Cancer
Date applied
12/02/2015
Date assigned
19/02/2015
Last edited
13/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Reduced tongue strength (TS) is an important contributing factor to early and late dysphagia (swallowing difficulties) in head and neck cancer (HNC) patients previously treated with chemoradiotherapy (CRT). The evidence is growing that tongue-strengthening exercises (TSE) can improve TS and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for TS on strength and/or swallowing function). Previous research in sports medicine and physical rehabilitation shows that degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat (a structure that helps manipulate food), it remains to be proven if the same concepts will apply. This study investigates the effect of 3 TSE protocols with different degrees of exercise load on TS and swallowing.

Who can participate?
Adult head and neck cancer patients previously treated with chemoradiotherapy and suffering from chronic dysphagia.

What does the study involve?
Participants will be randomly assigned to a training schedule of 60, 80, or 100% of their maximal TS respectively. They will be treated during 8 weeks, 3 times a week, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every two weeks. Patients are evaluated before, during and after treatment by means of TS measurements, fiber optic endoscopic evaluation of swallowing (FEES) and quality of life questionnaires.

What are the possible benefits and risks of participating?
A possible benefit is the increase of tongue strength to some degree, in some participants. There are no risks for patients participating in this study.

Where is the study run from?
Antwerp University Hospital (Belgium)

When is the study starting and how long is it expected to run for?
March 2014 to December 2016

Who is funding the study?
Antwerp University Hospital and Federal Cancer Plan Belgium

Who is the main contact?
Prof Gwen Van Nuffelen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gwen Van Nuffelen

ORCID ID

Contact details

Wilrijkstraat 10
Edegem (Antwerp)
2650
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NKR_2014_01

Study information

Scientific title

Effect of intensive tongue strength therapy on anterior and posterior tongue strength, dysphagia and dysphagia related quality of life.

Acronym

Study hypothesis

1. Tongue strengthening exercises improve tongue strength in head and neck cancer patients.
2. Tongue strengthening exercises improve functional swallowing in this population.
3. Tongue strengthening exercises improve swallowing related quality of life.
4. The effect of tongue strengthening exercises depend upon the level of resistance.

Ethics approval

Ethical Committee of the Antwerp University Hospital and University of Antwerp, Belgium. Chair: Prof. Dr. Patrick Cras. ref 14/24/253, B300201421549

Study design

Single-centre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients with dysphagia following head and neck cancer or neurodegenerative diseases.

Intervention

At enrollment, 45 head and neck cancer patients, whose dysphagia is primarily related to reduced tongue strength, are randomly assigned to a training schedule of 100% (group 1), 80% (group 2), or 60% (group 3) of their maximal TS respectively. Patients will be treated during 8 weeks, 3 times a week, executing once per training day 120 repetitions of the assigned exercise. Exercise load is progressively adjusted every two weeks. Patients are evaluated before, during and after treatment by means of TS measurements, fiberoptic endoscopic evaluation of swallowing (FEES) and quality of life questionnaires.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Tongue strength measurements: Maximum Isometric Pressures (expressed as kPa) anterior and posterior.
The primary measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of tehrapy), after 8 weeks of therapy and 4 and 8 weeks post treatment.

Secondary outcome measures

1. Swallowing function: the swallowing function will be evaluated using a comprehensive fiber optic endoscopic evaluation of swallowing (FEES) examination, the - Mann Assessment of Swallowing Ability-Cancer (MASA-C), the Functional Oral Intake Scale (FOIS), and a self-evaluation. For the latter a 100 mm visual analogue scale is used with the ends defined as ‘I can’t swallow’ (0) and ‘I don’t have any swallowing difficulties’ (100) respectively. Both the FEES and MASA-C are conducted with 4 different bolus types: 5 and 10 ml of thin liquid, and 5 and 10 ml of yoghurt. Each bolus type is administered 3 times. Outcome measures for FEES are the Penetration-Aspiration-Scale, the Carnaby- Video Fluoroscopic Examination (C-VFE) scales for dysphagia and aspiration, the Pooling-score and the Boston Residue and Clearance Scale (BRACS).
2. Quality of Life: swallowing-related quality of life will be surveyed by means of the Dutch Swallowing Quality-of-Life Questionnaire (DSWAL-QoL) and the Dysphagia Handicap Index.
The secondary outcome measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of tehrapy), after 8 weeks of therapy and 4 and 8 weeks post treatment.

Overall trial start date

01/03/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Head and neck cancer patients previously treated with chemoradiotherapy
2. Men and women older than 18, without cognitive, language, motor, hearing or visual deficits that could interfere with the correct execution of the training.
3. Chronic dysphagia (i.e. present for at least 1 month and no earlier than 6 months after the last day of radiation treatment), primarily related to reduced tongue strength
4. Score 1 or higher for the BRACS-items ‘base of tongue’ and/or ‘valleculae’ at baseline judged by an experienced clinician

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45 (15 per group)

Participant exclusion criteria

1. History of major oral or head and neck surgery and neurological disorders with an impact on oral function and/or swallowing (amongst others stroke, traumatic brain injury, Parkinson’s disease, Amyotrophic Lateral Sclerosis).
2. Concurrent oral motor exercises or swallowing maneuvers to improve swallowing are not allowed during the study period.

Recruitment start date

01/05/2014

Recruitment end date

01/11/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

Antwerp University Hospital
Edegem
-
Belgium

Sponsor information

Organisation

Antwerp University Hospital (Belgium)

Sponsor details

Wilrijkstraat 10
Edegem
2650
Belgium
+32 (0)3 821 34 41
gwen.van.nuffelen@uza.be

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Federal Cancer Plan Belgium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Antwerp University Hospital (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication of the study protocol
publication of the data at completion of the study
Presentation of the data at at least 2 international conferences including the Dysphagia Research society Meeting

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26340887

Publication citations

Additional files

Editorial Notes

13/06/2016: Publication reference added.