Cancer of Head and NeckReDyORNCT02900911

Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

A study testing Early rehabilitation and Late rehabilitation in people with Cancer of Head and Neck, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer of Head and Neck
What is being tested?: Early rehabilitation and Late rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteSpain
Study dates: May 2016to May 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with advanced head and neck cancer receiving radiotherapy

Who cannot join

Candidates to surgical treatment
Previous head and neck cancer
Dysphagia due to causes other than cancer
Previous head or neck radiation therapy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital de l'Esperança
Barcelona, 08024

Other trials in Spain

About this study

Official title: Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial

Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.

Read the detailed description

Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.

Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.

Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.

Conditions: Cancer of Head and Neck
Being tested: Early rehabilitation, Late rehabilitation
Keywords: head and neck cancer, dysphagia, rehabilitation, radiation therapy
Medical subject headings: Head and Neck Neoplasms, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early rehabilitationOther
Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy
Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day.
All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months.
Late rehabilitationOther
Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy

Study groups in NCT02900911
Study group	Role	What they receive
Early rehabilitation	Experimental	Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months Receives: Other: Early rehabilitation
Later rehabilitation	Active comparator	Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy Receives: Other: Late rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in dysphagia severity at three months post radiotherapy
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
Measured: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
Change in quality of life at three months post radiotherapy
Head \& Neck Cancer 35 (HN35)
Measured: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Secondary outcomes (2)

Change in dysphagia security signs at three months post radiotherapy
Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test
Measured: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Change in lingual Force at three months post radiotherapy
Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
Measured: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016May 2020

First posted14 Sep 2016 (estimated)
Study startMay 2016
Primary completionApr 2020
Study completionMay 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02900911
Sponsor's protocol ID: 2014/5707/l
Acronym: ReDyOR
Status last verified: Sep 2020
First submitted: 15 Feb 2016
Last updated: 21 Sep 2020
Results posted: No
Data monitoring committee: No

Publications

Stenson KM, MacCracken E, List M, Haraf DJ, Brockstein B, Weichselbaum R, Vokes EE. Swallowing function in patients with head and neck cancer prior to treatment. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):371-7. doi: 10.1001/archotol.126.3.371.
PubMed 10722011
Quer M, Leon X, Orus C, Recher K, Gras JR. [Analysis of 2,500 squamous cell carcinoma of the head and neck]. Acta Otorrinolaringol Esp. 2001 Apr;52(3):201-5. doi: 10.1016/s0001-6519(01)78198-8. Spanish.
PubMed 11526864
Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.
PubMed 16735913
Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
PubMed 17989581
Lazarus CL. Effects of chemoradiotherapy on voice and swallowing. Curr Opin Otolaryngol Head Neck Surg. 2009 Jun;17(3):172-8. doi: 10.1097/MOO.0b013e32832af12f.
PubMed 19337126
Dirix P, Abbeel S, Vanstraelen B, Hermans R, Nuyts S. Dysphagia after chemoradiotherapy for head-and-neck squamous cell carcinoma: dose-effect relationships for the swallowing structures. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):385-92. doi: 10.1016/j.ijrobp.2008.11.041. Epub 2009 Jun 24.
PubMed 19553033
Murphy BA, Gilbert J. Dysphagia in head and neck cancer patients treated with radiation: assessment, sequelae, and rehabilitation. Semin Radiat Oncol. 2009 Jan;19(1):35-42. doi: 10.1016/j.semradonc.2008.09.007.
PubMed 19028344
Platteaux N, Dirix P, Dejaeger E, Nuyts S. Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia. 2010 Jun;25(2):139-52. doi: 10.1007/s00455-009-9247-7. Epub 2009 Aug 27.
PubMed 19711127
Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.
PubMed 21136031
Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616.
PubMed 21430531
Lin PH, Hsiao TY, Chang YC, Ting LL, Chen WS, Chen SC, Wang TG. Effects of functional electrical stimulation on dysphagia caused by radiation therapy in patients with nasopharyngeal carcinoma. Support Care Cancer. 2011 Jan;19(1):91-9. doi: 10.1007/s00520-009-0792-2. Epub 2009 Nov 29.
PubMed 20091057
Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.
PubMed 22508621
Tedla M, Valach M, Carrau RL, Varga I, Profant M, Mraz P, Weismann P. Impact of radiotherapy on laryngeal intrinsic muscles. Eur Arch Otorhinolaryngol. 2012 Mar;269(3):953-8. doi: 10.1007/s00405-011-1686-8. Epub 2011 Jul 8.
PubMed 21739096
Russi EG, Corvo R, Merlotti A, Alterio D, Franco P, Pergolizzi S, De Sanctis V, Ruo Redda MG, Ricardi U, Paiar F, Bonomo P, Merlano MC, Zurlo V, Chiesa F, Sanguineti G, Bernier J. Swallowing dysfunction in head and neck cancer patients treated by radiotherapy: review and recommendations of the supportive task group of the Italian Association of Radiation Oncology. Cancer Treat Rev. 2012 Dec;38(8):1033-49. doi: 10.1016/j.ctrv.2012.04.002. Epub 2012 Apr 27.
PubMed 22542950
Hutcheson KA, Lewin JS, Barringer DA, Lisec A, Gunn GB, Moore MW, Holsinger FC. Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2012 Dec 1;118(23):5793-9. doi: 10.1002/cncr.27631. Epub 2012 May 17.
PubMed 23640737

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer of Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02900911
Acronym / sponsor ID: ReDyOR / 2014/5707/l
Conditions: Cancer of Head and Neck
Keywords: head and neck cancer, dysphagia, rehabilitation, radiation therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Parc de Salut MarUniversity, hospital or other
Collaborators: Asociación Española contra el Cáncer
Study start: May 2016
Primary completion: Apr 2020 (actual)
Study completion: May 2020 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early rehabilitation	Experimental	Other: Early rehabilitationEarly intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
Later rehabilitation	Active comparator	Other: Late rehabilitationLate intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with advanced head and neck cancer receiving radiotherapy

Key exclusion criteria (4 listed)

Candidates to surgical treatment
Previous head and neck cancer
Dysphagia due to causes other than cancer
Previous head or neck radiation therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early rehabilitationEarly swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day. All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months.	Other	Early rehabilitation
Late rehabilitationLate swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy	Other	Later rehabilitation

Primary outcome

Change in dysphagia severity at three months post radiotherapy
Time frame: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
Change in quality of life at three months post radiotherapy
Time frame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Head \& Neck Cancer 35 (HN35)

2 secondary outcomes

Change in dysphagia security signs at three months post radiotherapy
Time frame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Change in lingual Force at three months post radiotherapy
Time frame: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
Background: PubMed 10722011Stenson KM, MacCracken E, List M, Haraf DJ, Brockstein B, Weichselbaum R, Vokes EE. Swallowing function in patients with head and neck cancer prior to treatment. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):371-7. doi: 10.1001/archotol.126.3.371.
Background: PubMed 11526864Quer M, Leon X, Orus C, Recher K, Gras JR. [Analysis of 2,500 squamous cell carcinoma of the head and neck]. Acta Otorrinolaringol Esp. 2001 Apr;52(3):201-5. doi: 10.1016/s0001-6519(01)78198-8. Spanish.
Background: PubMed 16735913Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.
Background: PubMed 17989581Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
Background: PubMed 19337126Lazarus CL. Effects of chemoradiotherapy on voice and swallowing. Curr Opin Otolaryngol Head Neck Surg. 2009 Jun;17(3):172-8. doi: 10.1097/MOO.0b013e32832af12f.
Background: PubMed 19553033Dirix P, Abbeel S, Vanstraelen B, Hermans R, Nuyts S. Dysphagia after chemoradiotherapy for head-and-neck squamous cell carcinoma: dose-effect relationships for the swallowing structures. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):385-92. doi: 10.1016/j.ijrobp.2008.11.041. Epub 2009 Jun 24.
Background: PubMed 19028344Murphy BA, Gilbert J. Dysphagia in head and neck cancer patients treated with radiation: assessment, sequelae, and rehabilitation. Semin Radiat Oncol. 2009 Jan;19(1):35-42. doi: 10.1016/j.semradonc.2008.09.007.
Background: PubMed 19711127Platteaux N, Dirix P, Dejaeger E, Nuyts S. Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia. 2010 Jun;25(2):139-52. doi: 10.1007/s00455-009-9247-7. Epub 2009 Aug 27.
Background: PubMed 21136031Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.
Background: PubMed 21430531Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616.
Background: PubMed 20091057Lin PH, Hsiao TY, Chang YC, Ting LL, Chen WS, Chen SC, Wang TG. Effects of functional electrical stimulation on dysphagia caused by radiation therapy in patients with nasopharyngeal carcinoma. Support Care Cancer. 2011 Jan;19(1):91-9. doi: 10.1007/s00520-009-0792-2. Epub 2009 Nov 29.
Background: PubMed 22508621Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Early rehabilitation and Late rehabilitation in people with Cancer of Head and Neck, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dysphagia severity at three months post radiotherapy (time frame: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02900911, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.