Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

01-12-2020 | Radiotherapy | Study protocol

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

Authors: Margot Baudelet, Leen Van den Steen, Fréderic Duprez, Marc De Bodt, Sarah Deschuymer, Ann Goeleven, Isabel Hutsebaut, Steven Mariën, Sabine Meersschout, Daan Nevens, Sandra Nuyts, Marc Peeters, Pol Specenier, Michiel Van den Brekel, Lisette van der Molen, Caroline Vandenbruaene, Olivier Vanderveken, Joost Van Dinther, Carl Van Laer, Tom Vauterin, Hilde Verstraete, Gwen Van Nuffelen, Member of the Belgian PRESTO Group

Published in: Trials | Issue 1/2020

Login to get access

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.
Literature
1.
De Felice F, de Vincentiis M, Luzzi V, Magliulo G, Tombolini M, Ruoppolo G, et al. Late radiation-associated dysphagia in head and neck cancer patients: evidence, research and management. Oral Oncol. 2018;77:125–30.PubMedCrossRef
2.
Hutcheson KA, Lewin JS, Barringer DA, Lisec A, Gunn GB, Moore MW, et al. Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2012;118(23):5793–9.PubMedCrossRef
3.
Nguyen NP, Moltz CC, Frank C, Vos P, Smith HJ, Karlsson U, et al. Long-term aspiration following treatment for head and neck cancer. Oncology. 2008;74(1–2):25–30.PubMedCrossRef
4.
Al-Mamgani A, Mehilal R, van Rooij PH, Tans L, Sewnaik A, Levendag PC. Toxicity, quality of life, and functional outcomes of 176 hypopharyngeal cancer patients treated by (chemo)radiation: the impact of treatment modality and radiation technique. Laryngoscope. 2012;122(8):1789–95.PubMedCrossRef
5.
Rosenthal DI, Lewin JS, Eisbruch A. Prevention and treatment of dysphagia and aspiration after chemoradiation for head and neck cancer. J Clin Oncol. 2006;24(17):2636–43.PubMedCrossRef
6.
Gillespie MB, Brodsky MB, Day TA, Lee FS, Martin-Harris B. Swallowing-related quality of life after head and neck cancer treatment. Laryngoscope. 2004;114(8):1362–7.PubMedCrossRef
7.
Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, et al. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006;116(6):883–6.PubMedCrossRef
8.
Messing BP, Ward EC, Lazarus CL, Kim M, Zhou X, Silinonte J, et al. Prophylactic swallow therapy for patients with head and neck cancer undergoing chemoradiotherapy: a randomized trial. Dysphagia. 2017;32(4):487–500.PubMedPubMedCentralCrossRef
9.
Govender R, Smith CH, Gardner B, Barratt H, Taylor SA. Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study. BMJ Open. 2017;7(3):e014167.PubMedPubMedCentralCrossRef
10.
Dysphagia Section OCSGMAoSCiCISoOO, Raber-Durlacher JE, Brennan MT, Verdonck-de Leeuw IM, Gibson RJ, Eilers JG, et al. Swallowing dysfunction in cancer patients. Support Care Cancer. 2012;20(3):433–43.CrossRef
11.
Terrell JE, Ronis DL, Fowler KE, Bradford CR, Chepeha DB, Prince ME, et al. Clinical predictors of quality of life in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004;130(4):401–8.PubMedCrossRef
12.
Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, Leemans CR, Aaronson NK, Slotman BJ. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26(22):3770–6.PubMedCrossRef
13.
Epstein JB, Emerton S, Kolbinson DA, Le ND, Phillips N, Stevenson-Moore P, et al. Quality of life and oral function following radiotherapy for head and neck cancer. Head Neck. 1999;21(1):1–11.PubMedCrossRef
14.
Denaro N, Merlano MC, Russi EG. Dysphagia in head and neck cancer patients: pretreatment evaluation, predictive factors, and assessment during radio-chemotherapy, recommendations. Clin Exp Otorhinolaryngol. 2013;6(3):117–26.PubMedPubMedCentralCrossRef
15.
Krisciunas GP, Castellano K, McCulloch TM, Lazarus CL, Pauloski BR, Meyer TK, et al. Impact of compliance on dysphagia rehabilitation in head and neck cancer patients: results from a multi-center clinical trial. Dysphagia. 2017;32(2):327–36.PubMedCrossRef
16.
Rutten H, Pop LA, Janssens GO, Takes RP, Knuijt S, Rooijakkers AF, et al. Long-term outcome and morbidity after treatment with accelerated radiotherapy and weekly cisplatin for locally advanced head-and-neck cancer: results of a multidisciplinary late morbidity clinic. Int J Radiat Oncol Biol Phys. 2011;81(4):923–9.PubMedCrossRef
17.
Krisciunas GP, Sokoloff W, Stepas K, Langmore SE. Survey of usual practice: dysphagia therapy in head and neck cancer patients. Dysphagia. 2012;27(4):538–49.PubMedPubMedCentralCrossRef
18.
Roe JW, Carding PN, Rhys-Evans PH, Newbold KL, Harrington KJ, Nutting CM. Assessment and management of dysphagia in patients with head and neck cancer who receive radiotherapy in the United Kingdom—a web-based survey. Oral Oncol. 2012;48(4):343–8.PubMedCrossRef
19.
Carnaby-Mann G, Crary MA, Schmalfuss I, Amdur R. “Pharyngocise”: randomized controlled trial of preventative exercises to maintain muscle structure and swallowing function during head-and-neck chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2012;83(1):210–9.PubMedCrossRef
20.
van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011;26(2):155–70.PubMedCrossRef
21.
Hutcheson KA, Bhayani MK, Beadle BM, Gold KA, Shinn EH, Lai SY, et al. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013;139(11):1127–34.PubMedPubMedCentralCrossRef
22.
Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008;118(1):39–43.PubMedCrossRef
23.
Virani A, Kunduk M, Fink DS, McWhorter AJ. Effects of 2 different swallowing exercise regimens during organ-preservation therapies for head and neck cancers on swallowing function. Head Neck. 2015;37(2):162–70.PubMedCrossRef
24.
Duarte VM, Chhetri DK, Liu YF, Erman AA, Wang MB. Swallow preservation exercises during chemoradiation therapy maintains swallow function. Otolaryngol Head Neck Surg. 2013;149(6):878–84.PubMedPubMedCentralCrossRef
25.
Shinn EH, Basen-Engquist K, Baum G, Steen S, Bauman RF, Morrison W, et al. Adherence to preventive exercises and self-reported swallowing outcomes in post-radiation head and neck cancer patients. Head Neck. 2013;35(12):1707–12.PubMedPubMedCentralCrossRef
26.
Wall LR, Ward EC, Cartmill B, Hill AJ, Porceddu SV. Adherence to a prophylactic swallowing therapy program during (chemo) radiotherapy: impact of service-delivery model and patient factors. Dysphagia. 2017;32(2):279–92.PubMedCrossRef
27.
Cnossen IC, van Uden-Kraan CF, Rinkel RN, Aalders IJ, de Goede CJ, de Bree R, et al. Multimodal guided self-help exercise program to prevent speech, swallowing, and shoulder problems among head and neck cancer patients: a feasibility study. J Med Internet Res. 2014;16(3):e74.PubMedPubMedCentralCrossRef
28.
Sabaté E. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003.
29.
Rand CS. Measuring adherence with therapy for chronic diseases: implications for the treatment of heterozygous familial hypercholesterolemia. Am J Cardiol. 1993;72(10):68D–74D.PubMedCrossRef
30.
31.
Vitolins MZ, Rand CS, Rapp SR, Ribisl PM, Sevick MA. Measuring adherence to behavioral and medical interventions. Control Clin Trials. 2000;21(5 Suppl):188S–94S.PubMedCrossRef
32.
Peek K, Sanson-Fisher R, Mackenzie L, Carey M. Interventions to aid patient adherence to physiotherapist prescribed self-management strategies: a systematic review. Physiotherapy. 2016;102(2):127–35.PubMedCrossRef
33.
Van den Steen L, Vanderveken O, Vanderwegen J, Van Gestel D, Daisne JF, Allouche J, et al. Feasibility of tongue strength measurements during (chemo)radiotherapy in head and neck cancer patients. Support Care Cancer. 2017;25(11):3417–23.PubMedCrossRef
34.
Robbins J, Gangnon RE, Theis SM, Kays SA, Hewitt AL, Hind JA. The effects of lingual exercise on swallowing in older adults. J Am Geriatr Soc. 2005;53(9):1483–9.PubMedCrossRef
35.
Dejaeger E, Pelemans W, Ponette E, Joosten E. Mechanisms involved in postdeglutition retention in the elderly. Dysphagia. 1997;12(2):63–7.PubMedCrossRef
36.
Butler SG, Stuart A, Leng X, Wilhelm E, Rees C, Williamson J, et al. The relationship of aspiration status with tongue and handgrip strength in healthy older adults. J Gerontol A Biol Sci Med Sci. 2011;66(4):452–8.PubMedCrossRef
37.
Sze WP, Yoon WL, Escoffier N, Rickard Liow SJ. Evaluating the training effects of two swallowing rehabilitation therapies using surface electromyography—Chin Tuck Against Resistance (CTAR) exercise and the shaker exercise. Dysphagia. 2016;31(2):195–205.PubMedCrossRef
38.
Kraaijenga SA, van der Molen L, Stuiver MM, Teertstra HJ, Hilgers FJ, van den Brekel MW. Effects of strengthening exercises on swallowing musculature and function in senior healthy subjects: a prospective effectiveness and feasibility study. Dysphagia. 2015;30(4):392–403.PubMedCrossRef
39.
Lazarus C, Logemann JA, Song CW, Rademaker AW, Kahrilas PJ. Effects of voluntary maneuvers on tongue base function for swallowing. Folia Phoniatr Logop. 2002;54(4):171–6.PubMedCrossRef
40.
Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, et al. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehab. 2007;88(2):150–8.CrossRef
41.
Oh JC. Effects of tongue strength training and detraining on tongue pressures in healthy adults. Dysphagia. 2015;30(3):315–20.PubMedCrossRef
42.
Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015;27(12):3631–4.PubMedPubMedCentralCrossRef
43.
Rogus-Pulia N, Rusche N, Hind JA, Zielinski J, Gangnon R, Safdar N, et al. Effects of device-facilitated isometric progressive resistance oropharyngeal therapy on swallowing and health-related outcomes in older adults with dysphagia. J Am Geriatr Soc. 2016;64(2):417–24.PubMedCrossRef
44.
Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007;22(3):251–65.PubMedCrossRef
45.
Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel M, et al. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017;39(10):1943–61.PubMedCrossRef
46.
Starmer HM, Abrams R, Webster K, Kizner J, Beadle B, Holsinger FC, et al. Feasibility of a mobile application to enhance swallowing therapy for patients undergoing radiation-based treatment for head and neck cancer. Dysphagia. 2018;33(2):227–33.PubMedCrossRef
47.
Van den Steen L, Schellen C, Verstraelen K, Beeckman AS, Vanderwegen J, De Bodt M, et al. Tongue-strengthening exercises in healthy older adults: specificity of bulb position and detraining effects. Dysphagia. 2018;33(3):337–4.PubMedCrossRef
48.
Van Nuffelen G, Van den Steen L, Vanderveken O, Specenier P, Van Laer C, Van Rompaey D, et al. Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter? Trials. 2015;16:395.PubMedPubMedCentralCrossRef
49.
Carnaby GD, Crary MA. Development and validation of a cancer-specific swallowing assessment tool: MASA-C. Support Care Cancer. 2014;22(3):595–602.PubMedCrossRef
50.
Cheney DM, Siddiqui MT, Litts JK, Kuhn MA, Belafsky PC. The ability of the 10-Item Eating Assessment Tool (EAT-10) to predict aspiration risk in persons with dDysphagia. Ann Otol Rhinol Laryngol. 2015;124(5):351–4.PubMedCrossRef
51.
Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005;86(8):1516–20.PubMedCrossRef
52.
Vanderwegen J, Van Nuffelen G, De Bodt M. The validation and psychometric properties of the Dutch version of the Swallowing Quality-of-Life Questionnaire (DSWAL-QOL). Dysphagia. 2013;28(1):11–23.PubMedCrossRef
53.
Silbergleit AK, Schultz L, Jacobson BH, Beardsley T, Johnson AF. The Dysphagia Handicap Index: development and validation. Dysphagia. 2012;27(1):46–52.PubMedCrossRef
54.
Costa PT, MacCrae RR. Revised NEO Personality Inventory (NEO-PI-R) and NEO Five-factor Inventory (NEO-FFI) professional manual. Odessa: Psychological Assessment Resources; 1992.
55.
Epstein JB, Beaumont JL, Gwede CK, Murphy B, Garden AS, Meredith R, et al. Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer. 2007;109(9):1914–22.PubMedCrossRef
56.
Sluijs EM, Kok GJ, van der Zee J. Correlates of exercise compliance in physical therapy. Phys Ther. 1993;73(11):771–82 discussion 83-6.PubMedCrossRef
57.
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39(3):315–25.PubMedCrossRef
58.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
Metadata
Title
Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)
Authors
Margot Baudelet
Leen Van den Steen
Fréderic Duprez
Marc De Bodt
Sarah Deschuymer
Ann Goeleven
Isabel Hutsebaut
Steven Mariën
Sabine Meersschout
Daan Nevens
Sandra Nuyts
Marc Peeters
Pol Specenier
Michiel Van den Brekel
Lisette van der Molen
Caroline Vandenbruaene
Olivier Vanderveken
Joost Van Dinther
Carl Van Laer
Tom Vauterin
Hilde Verstraete
Gwen Van Nuffelen
Member of the Belgian PRESTO Group
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4171-0

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Research

Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention

Study protocol

Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (≤ 32 weeks): study protocol for a randomized controlled trial

Study protocol

Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial

Correction

Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

Study protocol

Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials

Study protocol

Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) – Study protocol from a randomized controlled trial