DysphagiaNCT01349309

The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients

A study testing Swallowing Exercise Group in people with Dysphagia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to find out if doing prophylactic or preventative swallowing exercises from the start of cancer treatment can improve the ability to swallow when the treatment is completed and beyond. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Swallowing Exercise Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Jan 2011
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

Patient diagnosed with head and neck cancer who will be receiving radiation therapy either alone of with chemotherapy as their treatment modality.

Who cannot join

Patients with a history of neurologic disease
Patients with previous head and neck cancer or surgical or radiation treatment to the head and neck region
Patients taking medication that might effect their swallowing function
Patients with gastroenterologic dysfunction
Patients who have previously undergone swallowing therapy
Patients with cognitive impairments that limit their ability to follow and comply with multi-step commands

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Read the detailed description

Study Type: Prospective Randomized Clinical Trial

Introduction:

Organ sparing treatment for advanced head and neck cancer can affect the swallowing mechanism via fibrosis of the structures responsible for effective and efficient bolus movement from the oral cavity and through the pharynx into the esophagus. This fibrosis may result in significant impairment of bolus transport. Range of motion exercises for the swallowing structures may decrease the fibrotic effects of the radiation treatment and improve swallowing outcomes after treatment.

Intervention:

Patients who have been diagnosed with head and neck cancer and who will be receiving radiation therapy either with or without chemotherapy as cancer treatment will be randomized to one of two swallowing treatment protocols. The first protocol will include the initiation of intensive swallowing exercises to begin at the start of the cancer treatment. The second treatment protocol will include the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient. Patients will not be given a choice of swallowing protocol. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis. The same investigator will provide all the swallowing treatment assuring that all patients get the same treatment approach.

All patients will fill out a questionnaire about their swallowing ability called the Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N). This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. This questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment. In addition, the nature of the patient's oral intake will be documented by the investigator using the Functional Oral Intake Scale (FOIS) which is a seven point scale of diet tolerance. This will be performed at the same intervals as the PSS-H\&N. Presence or absence of PEG feedings will also be documented at these same times. These scales will then be used to compare the swallowing outcomes of the patients in the two different treatment protocols.

Conditions: Dysphagia
Being tested: Swallowing Exercise Group
Keywords: Prophylactic Swallowing Exercises, Head and Neck Cancer, Dysphagia
Medical subject headings: Deglutition Disorders, Head and Neck Neoplasms

What participants receive

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

Swallowing Exercise GroupBehavioural
Also called Prophylactic Swallowing Exercises
Swallowing Exercises
Perform each exercise 10 times. Do these 3 times a day. Vary the order of the exercises.
Effortful Swallow: As you swallow squeeze hard with all your muscles. (Can do with water or without)
Super Supraglottic Swallow:
Inhale and hold your breath very tightly, bearing down. Keep holding your breath and bearing down as you swallow. Cough when you are finished. (Can do with water or without)
Tongue Hold Maneuver:
Gently hold your tongue in between your front teeth and swallow your saliva.
Tongue Retraction:
Pull the back of your tongue to the back of your mouth and hold.
Mendelsohn Maneuver:
Swallow your saliva and pay attention to your neck as you swallow. Try to feel that something (your Adam's apple of voice box) lifts and lowers as you swallow. Now, when you swallow and you feel something lift as you swallow don't let it drop. Hold it with your muscles for several seconds.

Study groups in NCT01349309
Study group	Role	What they receive
Swallowing Exercise Group	Experimental	Swallowing Exercise Group: This arm will undergo the protocol that involves intensive swallowing exercises to begin at the start of the cancer treatment. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis. Receives: Behavioral: Swallowing Exercise Group
Control	No intervention	Control Arm: This arm will receive the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient.

What is being measured

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

Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Measured: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
Functional Oral Intake Scale (FOIS)
A seven point scale of diet tolerance.
Measured: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.

Timeline

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

Jun 2007Jan 2011

First posted6 May 2011 (estimated)
Study startJun 2007
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349309
Sponsor's protocol ID: GCO # 07-0462
Status last verified: Dec 2015
First submitted: 28 Feb 2011
Last updated: 4 Dec 2015
Results posted: No
Data monitoring committee: No

Publications

Lee NY, de Arruda FF, Puri DR, Wolden SL, Narayana A, Mechalakos J, Venkatraman ES, Kraus D, Shaha A, Shah JP, Pfister DG, Zelefsky MJ. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):966-74. doi: 10.1016/j.ijrobp.2006.06.040.
PubMed 17145527
El-Sayed S, Nelson N. Adjuvant and adjunctive chemotherapy in the management of squamous cell carcinoma of the head and neck region. A meta-analysis of prospective and randomized trials. J Clin Oncol. 1996 Mar;14(3):838-47. doi: 10.1200/JCO.1996.14.3.838.
PubMed 8622032
Pignon JP, Bourhis J, Domenge C, Designe L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000 Mar 18;355(9208):949-55.
PubMed 10768432
Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219.
PubMed 10829041
Kramer S, Gelber RD, Snow JB, Marcial VA, Lowry LD, Davis LW, Chandler R. Combined radiation therapy and surgery in the management of advanced head and neck cancer: final report of study 73-03 of the Radiation Therapy Oncology Group. Head Neck Surg. 1987 Sep-Oct;10(1):19-30. doi: 10.1002/hed.2890100105.
PubMed 3449477
Robbins KT. Barriers to winning the battle with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):4-5. doi: 10.1016/s0360-3016(02)02713-x. No abstract available.
PubMed 12007934
Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. doi: 10.1093/jnci/91.24.2081.
PubMed 10601378
Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
PubMed 9632446
Vokes EE, Stenson K, Rosen FR, Kies MS, Rademaker AW, Witt ME, Brockstein BE, List MA, Fung BB, Portugal L, Mittal BB, Pelzer H, Weichselbaum RR, Haraf DJ. Weekly carboplatin and paclitaxel followed by concomitant paclitaxel, fluorouracil, and hydroxyurea chemoradiotherapy: curative and organ-preserving therapy for advanced head and neck cancer. J Clin Oncol. 2003 Jan 15;21(2):320-6. doi: 10.1200/JCO.2003.06.006.
PubMed 12525525
Newman LA, Vieira F, Schwiezer V, Samant S, Murry T, Woodson G, Kumar P, Robbins KT. Eating and weight changes following chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 1998 May;124(5):589-92. doi: 10.1001/archotol.124.5.589.
PubMed 9604988
Adelstein DJ, Saxton JP, Lavertu P, Rybicki LA, Esclamado RM, Wood BG, Strome M, Carroll MA. Maximizing local control and organ preservation in stage IV squamous cell head and neck cancer With hyperfractionated radiation and concurrent chemotherapy. J Clin Oncol. 2002 Mar 1;20(5):1405-10. doi: 10.1200/JCO.2002.20.5.1405.
PubMed 11870186
Smith RV, Kotz T, Beitler JJ, Wadler S. Long-term swallowing problems after organ preservation therapy with concomitant radiation therapy and intravenous hydroxyurea: initial results. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):384-9. doi: 10.1001/archotol.126.3.384.
PubMed 10722013
Hutcheson KA, Barringer DA, Rosenthal DI, May AH, Roberts DB, Lewin JS. Swallowing outcomes after radiotherapy for laryngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2008 Feb;134(2):178-83. doi: 10.1001/archoto.2007.33.
PubMed 18283161
Bleier BS, Levine MS, Mick R, Rubesin SE, Sack SZ, McKinney K, Mirza N. Dysphagia after chemoradiation: analysis by modified barium swallow. Ann Otol Rhinol Laryngol. 2007 Nov;116(11):837-41. doi: 10.1177/000348940711601108.
PubMed 18074669
Murry T, Madasu R, Martin A, Robbins KT. Acute and chronic changes in swallowing and quality of life following intraarterial chemoradiation for organ preservation in patients with advanced head and neck cancer. Head Neck. 1998 Jan;20(1):31-7. doi: 10.1002/(sici)1097-0347(199801)20:13.0.co;2-4.
PubMed 9464950

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
ClinicalTrials.gov ID: NCT01349309
Acronym / sponsor ID: GCO # 07-0462
Conditions: Dysphagia
Keywords: Prophylactic Swallowing Exercises, Head and Neck Cancer, Dysphagia
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Study start: Jun 2007
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 6 May 2011 (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 Type: Prospective Randomized Clinical Trial

Introduction:

Intervention:

Study design

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

Arm	Type	Receives
Swallowing Exercise Group	Experimental	Behavioral: Swallowing Exercise GroupSwallowing Exercise Group: This arm will undergo the protocol that involves intensive swallowing exercises to begin at the start of the cancer treatment. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis.
Control	No intervention	–Control Arm: This arm will receive the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient.

Who may qualify

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

Key inclusion criteria (1 listed)

Patient diagnosed with head and neck cancer who will be receiving radiation therapy either alone of with chemotherapy as their treatment modality.

Key exclusion criteria (6 listed)

Patients with a history of neurologic disease
Patients with previous head and neck cancer or surgical or radiation treatment to the head and neck region
Patients taking medication that might effect their swallowing function
Patients with gastroenterologic dysfunction
Patients who have previously undergone swallowing 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
Swallowing Exercise GroupAlso: Prophylactic Swallowing ExercisesSwallowing Exercises Perform each exercise 10 times. Do these 3 times a day. Vary the order of the exercises. Effortful Swallow: As you swallow squeeze hard with all your muscles. (Can do with water or without) Super Supraglottic Swallow: Inhale and hold your breath very tightly, bearing down. Keep holding your breath and bearing down as you swallow. Cough when you are finished. (Can do with water or without) Tongue Hold Maneuver: Gently hold your tongue in between your front teeth and swallow your saliva. Tongue Retraction: Pull the back of your tongue to the back of your mouth and hold. Mendelsohn Maneuver: Swallow your saliva and pay attention to your neck as you swallow. Try to feel that something (your Adam's apple of voice box) lifts and lowers as you swallow. Now, when you swallow and you feel something lift as you swallow don't let it drop. Hold it with your muscles for several seconds.	Behavioural	Swallowing Exercise Group

Primary outcome

Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
Time frame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
Time frame: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.

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 4 Dec 2015.
Background: PubMed 17145527Lee NY, de Arruda FF, Puri DR, Wolden SL, Narayana A, Mechalakos J, Venkatraman ES, Kraus D, Shaha A, Shah JP, Pfister DG, Zelefsky MJ. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):966-74. doi: 10.1016/j.ijrobp.2006.06.040.
Background: PubMed 8622032El-Sayed S, Nelson N. Adjuvant and adjunctive chemotherapy in the management of squamous cell carcinoma of the head and neck region. A meta-analysis of prospective and randomized trials. J Clin Oncol. 1996 Mar;14(3):838-47. doi: 10.1200/JCO.1996.14.3.838.
Background: PubMed 10768432Pignon JP, Bourhis J, Domenge C, Designe L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000 Mar 18;355(9208):949-55.
Background: PubMed 10829041Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219.
Background: PubMed 3449477Kramer S, Gelber RD, Snow JB, Marcial VA, Lowry LD, Davis LW, Chandler R. Combined radiation therapy and surgery in the management of advanced head and neck cancer: final report of study 73-03 of the Radiation Therapy Oncology Group. Head Neck Surg. 1987 Sep-Oct;10(1):19-30. doi: 10.1002/hed.2890100105.
Background: PubMed 12007934Robbins KT. Barriers to winning the battle with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):4-5. doi: 10.1016/s0360-3016(02)02713-x. No abstract available.
Background: PubMed 10601378Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. doi: 10.1093/jnci/91.24.2081.
Background: PubMed 9632446Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
Background: PubMed 12525525Vokes EE, Stenson K, Rosen FR, Kies MS, Rademaker AW, Witt ME, Brockstein BE, List MA, Fung BB, Portugal L, Mittal BB, Pelzer H, Weichselbaum RR, Haraf DJ. Weekly carboplatin and paclitaxel followed by concomitant paclitaxel, fluorouracil, and hydroxyurea chemoradiotherapy: curative and organ-preserving therapy for advanced head and neck cancer. J Clin Oncol. 2003 Jan 15;21(2):320-6. doi: 10.1200/JCO.2003.06.006.
Background: PubMed 9604988Newman LA, Vieira F, Schwiezer V, Samant S, Murry T, Woodson G, Kumar P, Robbins KT. Eating and weight changes following chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 1998 May;124(5):589-92. doi: 10.1001/archotol.124.5.589.
Background: PubMed 11870186Adelstein DJ, Saxton JP, Lavertu P, Rybicki LA, Esclamado RM, Wood BG, Strome M, Carroll MA. Maximizing local control and organ preservation in stage IV squamous cell head and neck cancer With hyperfractionated radiation and concurrent chemotherapy. J Clin Oncol. 2002 Mar 1;20(5):1405-10. doi: 10.1200/JCO.2002.20.5.1405.
Background: PubMed 10722013Smith RV, Kotz T, Beitler JJ, Wadler S. Long-term swallowing problems after organ preservation therapy with concomitant radiation therapy and intravenous hydroxyurea: initial results. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):384-9. doi: 10.1001/archotol.126.3.384.

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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.

Tamar Kotz, MS, CCC, SLP principal investigator

Icahn School of Medicine at Mount Sinai

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

Questions about this trial

What is this clinical trial studying?

A study testing Swallowing Exercise Group in people with Dysphagia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

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 6 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 4 Dec 2015. 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 United States. 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?

Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N). (time frame: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.). The study lists 12 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 NCT01349309, which also lists 27 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 4 Dec 2015.