Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background

Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function. However, low adherence rates are a key issue in undermining this positive effect. This current randomized trial will investigate the effect of adherence-improving measures on patients’ swallowing function, adherence and quality of life (QOL).

Methods

This ongoing trial will explore the difference in adherence and swallowing-related outcome variables during and after PSE in HNC patients performing the same therapy schedule, receiving different delivery methods. One hundred and fifty patients treated in various hospitals will be divided into three groups. Group 1 performs PSE at home, group 2 practices at home with continuous counseling through an app and group 3 receives face-to-face therapy by a speech and language pathologist. The exercises consist of tongue-strengthening exercises and chin-tuck against resistance with effortful swallow. The Iowa Oral Performance Instrument and the Swallowing Exercise Aid are used for practicing. Patients are evaluated before, during and after treatment by means of strength measurements, swallowing and QOL questionnaires.

Discussion

Since low adherence rates undermine the positive impact of PSE on post-treatment swallowing function, there is need to develop an efficient PSE protocol maximizing adherence rates.

Trial registration

ISRCTN, ID: ISRCTN98243550. Registered retrospectively on 21 December 2018.

Related collections

Most cited references 36

Record: found
Abstract: found
Article: not found

Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy.

Johannes A Langendijk, Patricia Doornaert, Irma M. Verdonck-de Leeuw … (2008)

To investigate the impact of treatment-related toxicity on health-related quality of life (HRQoL) among patients with head and neck squamous cell carcinoma treated with radiotherapy either alone or in combination with chemotherapy or surgery. The study sample was composed of 425 disease-free patients. Toxicity was scored according to the European Organisation for Research and Treatment of Cancer (EORTC)/Radiation Therapy Oncology Group (RTOG) late radiation-induced morbidity scoring system. HRQoL was assessed using the EORTC Quality of Life Questionnaire C30. These assessments took place at 6, 12, 18, and 24 months after completion of radiotherapy. The analysis was performed using a multivariate analysis of variance. Of the six RTOG scales investigated, two significantly affected self-reported HRQoL, salivary gland (RTOG(xerostomia)) and esophagus/pharynx (RTOG(swallowing)). Although RTOG(xerostomia) was reported most frequently, HRQoL was most affected by RTOG(swallowing), particularly in the first 18 months after completion of radiotherapy. Late radiation-induced toxicity, particularly RTOG(swallowing) and RTOG(xerostomia), has a significant impact on the more general dimensions of HRQoL. These findings suggest that the development of new radiation-induced delivery techniques should not only focus on reduction of the dose to the salivary glands, but also on anatomic structures that are involved in swallowing.

0 comments Cited 162 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Clinical predictors of quality of life in patients with head and neck cancer.

Douglas B. Chepeha, Mark E. Prince, Jeffrey Terrell … (2004)

To identify clinical predictors of quality of life (QoL) in a head and neck cancer patient population. A convenience sample of 570 patients with upper aerodigestive tract cancers were surveyed at a tertiary care oncology clinic and Veterans Affairs otolaryngology clinic. A self-administered health survey was constructed to collect demographic, health, smoking, alcohol, depression symptom, and QoL information. Tumor site and tumor stage, clinical, and treatment data were abstracted from the patient medical records. Quality of life was assessed using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and the Head and Neck QoL (HNQoL) instrument. Of the 570 eligible respondents, the presence of a feeding tube had the most negative impact on QoL, with significant decrements in 6 of the 8 SF-36 scales and all 4 HNQoL scales (P<.01). In descending order of severity, medical comorbid conditions, presence of a tracheotomy tube, chemotherapy, and neck dissection were also associated with significant (P<.05) decrements in QoL domains. Patients who took the survey more than 1 year after diagnosis had improved QoL in 7 of 12 domains. Hospital site, age, education level, sex, race, and marital status were also significant predictors of QoL. There are at least 13 demographic and clinical characteristics that are significant predictors of QoL in patients with head and neck cancer, which should be considered when treating patients and conducting QoL studies in the future.

0 comments Cited 74 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Prevention and treatment of dysphagia and aspiration after chemoradiation for head and neck cancer.

David Rosenthal, S Lewin, Avraham Eisbruch (2006)

Safe, successful swallowing depends on complex events affected by head and neck cancers and their treatment. This article reviews the swallowing process, how it is affected by chemoradiotherapy, and the evaluation, prevention, and treatment of swallowing disorders. Specific recommendations are made to promote maintenance and recovery of swallowing function.

0 comments Cited 70 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Margot Baudelet:

ORCID: http://orcid.org/0000-0003-0431-5854

Margot.Baudelet@UGent.be

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 2 March 2020

Publication date PMC-release: 2 March 2020

Publication date Collection: 2020

Volume: 21

Electronic Location Identifier: 237

Affiliations

[1 ]ISNI 0000 0004 0626 3303, GRID grid.410566.0, Department of Radiation Oncology, , Ghent University Hospital, ; Corneel Heymanslaan 10, 9000 Ghent, Belgium

[2 ]ISNI 0000 0001 2069 7798, GRID grid.5342.0, Faculty of Medicine and Health Sciences, Department of Human Structure and Repair, , Ghent University, ; St. Pietersnieuwstraat 33, 9000 Ghent, Belgium

[3 ]ISNI 0000 0001 0790 3681, GRID grid.5284.b, Faculty of Medicine and Health Sciences, , University of Antwerp, ; Universiteitsplein 1 Wilrijk, 2610 Antwerp, Belgium

[4 ]ISNI 0000 0004 0626 3418, GRID grid.411414.5, Department of Otolaryngology and Head and Neck Surgery – Rehabilitation Center for Communication Disorders, , Antwerp University Hospital, ; Antwerp, Belgium

[5 ]ISNI 0000 0001 2069 7798, GRID grid.5342.0, Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences, , Ghent University, ; St. Pietersnieuwstraat 33, 9000 Ghent, Belgium

[6 ]Department of Radiation Oncology, KU Leuven, University Hospitals Leuven, Leuven, Belgium

[7 ]ISNI 0000 0004 0626 3338, GRID grid.410569.f, Department of ENT, , University Hospitals Leuven, Swallowing Clinic, ; Leuven, Belgium

[8 ]ISNI 0000 0004 0626 3338, GRID grid.410569.f, Department of Head and Neck Surgery, , University Hospitals Leuven, Swallowing Clinic, ; Leuven, Belgium

[9 ]ISNI 0000 0004 0626 3792, GRID grid.420036.3, Department of Radiation Oncology, , AZ Sint-Jan General Hospital, ; Bruges, Belgium

[10 ]Department of Radiation Oncology, Iridium Kanker Netwerk, Antwerp, Belgium

[11 ]Multi-disciplinary Oncological Center Antwerp, Antwerp, Belgium

[12 ]ISNI 0000 0001 0668 7884, GRID grid.5596.f, Laboratory of Experimental Radiotherapy, Department of Oncology, , KU Leuven, ; Leuven, Belgium

[13 ]ISNI 0000 0004 0626 3418, GRID grid.411414.5, Department Medical Oncology, , Antwerp University Hospital, ; Antwerp, Belgium

[14 ]GRID grid.430814.a, Department of Head and Neck Oncology and Surgery, Antoni van Leeuwenhoek, , Netherlands Cancer Institute, ; Amsterdam, The Netherlands

[15 ]ISNI 0000000084992262, GRID grid.7177.6, Faculty of Humanities, , University of Amsterdam, ; Spui 21, 1012 WX Amsterdam, The Netherlands

[16 ]Department of Speech-Language Pathology and Audiology, Sint-Jan General Hospital, Bruges, Belgium

[17 ]GRID grid.428965.4, Department of Otorhinolaryngology, , Sint-Augustinus Hospital, ; Antwerp, Belgium

[18 ]ISNI 0000 0004 0626 3792, GRID grid.420036.3, Department of Otorhinolaryngology-Head and Neck Surgery, , AZ Sint-Jan General Hospital, ; Bruges, Belgium

Author information

Margot Baudelet http://orcid.org/0000-0003-0431-5854

Article

Publisher ID: 4171

DOI: 10.1186/s13063-020-4171-0

PMC ID: 7053144

PubMed ID: 32122397

SO-VID: 8b5eb751-cc45-479d-a041-94e244436485

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 31 October 2019

Date accepted : 13 February 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100011851, Kom op tegen Kanker;

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: dysphagia,head-and-neck cancer,adherence,prophylactic swallowing exercises,(chemo)radiotherapy

Data availability:

ScienceOpen disciplines: Medicine

Keywords: dysphagia, head-and-neck cancer, adherence, prophylactic swallowing exercises, (chemo)radiotherapy

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

Read this article at

Abstract

Background

Methods

Discussion

Trial registration

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 36

Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy.

Clinical predictors of quality of life in patients with head and neck cancer.

Prevention and treatment of dysphagia and aspiration after chemoradiation for head and neck cancer.

Author and article information

Contributors

Journal

Affiliations

Author information

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 326

Cited by 10

Most referenced authors 641