Head & Neck CancerPhase 2PharyngociseNCT00796952
Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients
A Phase 2 study testing focused attention sessions, Valchuff and Pharyngocise in people with Head & Neck Cancer, run by University of Florida at 1 site in United States.
Trial summary
Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head /… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- focused attention sessions, Valchuff and Pharyngocise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Apr 2005
- Phase
- Phase 2
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
- Planned to undergo external beam radiation therapy,
- No previous history of nonoral feeding for cancer related illness,
- Able to undergo MRI procedures.
- Physician / patient agreement to participate
Who cannot join
- Planned surgical intervention
- Existence of a co-existing neurological or medical disorder known to cause dysphagia
- Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
- Previous swallowing therapy within four weeks of randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Health Science Center
Gainesville, Florida, 32610
About this study
Official title: Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.
Read the detailed description
Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to control the disease are often devastating to the functional feeding outcome in these patients. Most patients will experience some degree of dysphagia along with nutritional decline. In particular, the swallowing outcome of those patients treated with external beam radiation is suggested to be poorer than those patients treated by surgical interventions alone. It has also been postulated that the formation of radiation-induced fibrotic tissue, along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to promote muscular disuse or atrophy, and the noted decline in swallowing function. We therefore suggest that a program of swallowing exercises may help facilitate and maintain muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or supporting swallowing function in these patients.
This study will follow a randomized controlled trial design. Patients with confirmed head / neck cancer identified for planned radiotherapy will undergo a baseline evaluation including clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to CRT. Subjects will then be randomized to one of three intervention arms representing control, placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient perception of swallowing function and quality of life.The results of the study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the maintenance of swallowing function post radiotherapy for Head /Neck cancer.
- Conditions
- Head & Neck Cancer
- Being tested
- focused attention sessions, Valchuff, Pharyngocise
- Keywords
- Head/ neck cancer, Swallowing, behavioral treatment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused attention sessionsBehavioural
Patient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period.
ValchuffBehavioural
Standardised sham or placebo swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment.
PharyngociseBehavioural
Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patient management by the attending Radiation oncologist "as usual". Receives: Behavioral: focused attention sessions |
| Pharyngocise | Experimental | Standardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their chemo-radiation treatment (up to a maximum of 6 weeks) Receives: Behavioral: Pharyngocise |
| Valchuff | Sham comparator | Standardised sham swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of chemo-radiation treatment. Receives: Behavioral: Valchuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
Measured: Baseline, 6 weeks( end of CRT), 6 months(following CRT)
Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation
Measured: Baseline, 6 week(end of CRT), 6 months(following CRT)
Patient perception of swallowing ability
Measured: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Quality of Life
Measured: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Secondary outcomes (3)
Taste perception
Measured: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Perception of smell
Measured: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Salivation rates
Measured: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2001
- Primary completionJul 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Giselle Carnaby-Mann, PhD, Principal investigator, University of FloridaMichael Crary, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796952
- Sponsor's protocol ID
- BM009
- Acronym
- Pharyngocise
- Status last verified
- Sep 2011
- First submitted
- 21 Nov 2008
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Composition and Function for Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy: a Randomized Controlled Trial of Swallowing Therapy"
- ClinicalTrials.gov ID
- NCT00796952
- Acronym / sponsor ID
- Pharyngocise / BM009
- Conditions
- Head & Neck Cancer
- Keywords
- Head/ neck cancer, Swallowing, behavioral treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- Nov 2001
- Primary completion
- Jul 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 24 Nov 2008 (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.
Swallowing dysfunction after chemo-radiation is common, but there is no reliable evidence for how it should be managed. This pilot randomized controlled trial evaluated the relative benefit of a battery of isometric / isotonic exercises on the maintenance of muscle composition and function for swallowing in Head / Neck Cancer patients undergoing chemo-radiation therapy.
Detailed description
Swallowing deficits resulting from oropharyngeal cancer and the ablative therapies used to control the disease are often devastating to the functional feeding outcome in these patients. Most patients will experience some degree of dysphagia along with nutritional decline. In particular, the swallowing outcome of those patients treated with external beam radiation is suggested to be poorer than those patients treated by surgical interventions alone. It has also been postulated that the formation of radiation-induced fibrotic tissue, along with the acute radiation effects (edema, mucositis, xerostomia) may act collectively to promote muscular disuse or atrophy, and the noted decline in swallowing function. We therefore suggest that a program of swallowing exercises may help facilitate and maintain muscle function in the oral cavity and pharynx during radiotherapy, thus preserving or supporting swallowing function in these patients.
This study will follow a randomized controlled trial design. Patients with confirmed head / neck cancer identified for planned radiotherapy will undergo a baseline evaluation including clinical and instrumental swallowing assessment, nutritional examination, and MRI prior to CRT. Subjects will then be randomized to one of three intervention arms representing control, placebo and intervention groups. Patients will be treated for 6 weeks and progress reassessed at 6 months. Outcome assessment will be completed by a blinded observer. Primary outcomes include; I)Oropharyngeal active muscle volume, signal intensity, and tissue composition over time as identified by T2 weighted MRI, II)Level of functional swallowing ability,III)Patient perception of swallowing function and quality of life.The results of the study will provide information on the efficacy (or lack of efficacy) of isometric / isotonic exercises for the maintenance of swallowing function post radiotherapy for Head /Neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: focused attention sessionsPatient management by the attending Radiation oncologist "as usual". |
| Pharyngocise | Experimental | Behavioral: PharyngociseStandardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their chemo-radiation treatment (up to a maximum of 6 weeks) |
| Valchuff | Sham comparator | Behavioral: ValchuffStandardised sham swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of chemo-radiation treatment. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Head / neck cancer of the oropharyngeal or adjacent regions, confirmed by clinical history and exam, with positive cross sectional imaging studies and histopathological biopsy excluding other pathology.
- Planned to undergo external beam radiation therapy,
- No previous history of nonoral feeding for cancer related illness,
- Able to undergo MRI procedures.
- Physician / patient agreement to participate
Key exclusion criteria (4 listed)
- Planned surgical intervention
- Existence of a co-existing neurological or medical disorder known to cause dysphagia
- Prior radiotherapy or surgery to the head / neck region that could contribute to dysphagia.
- Previous swallowing therapy within four weeks of randomization
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 |
|---|---|---|
| focused attention sessionsPatient management by the attending Radiation oncologist "as usual". Patients assigned to this condition received focused attention sessions during the total course of their CRT treatment from a Speech Language Pathologist, consisting of weekly phone calls to monitor their swallowing outcome during the radiotherapy period. | Behavioural | Usual Care |
| ValchuffStandardised sham or placebo swallowing therapy comprised a buccal extension maneuver ("valchuff") and appropriate dietary modification, under the direction of the study speech pathologist, twice daily each week for the duration of the patient's total course of CRT treatment. | Behavioural | Valchuff |
| PharyngociseStandardized high intensity behavioral swallowing therapy (Pharyngocise) comprised a battery of direct isometric / isotonic exercises and appropriate dietary modification, under the direction of the study speech pathologist, twice daily for the duration of the patient's total course of their CRT treatment (up to a maximum of 6 weeks) | Behavioural | Pharyngocise |
Primary outcome
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI
Time frame: Baseline, 6 weeks( end of CRT), 6 months(following CRT)
Level of functional swallowing ability- measured by functional eating score (FOIS), clinical swallowing score, videoendoscopy and videofluoroscopic evaluation
Time frame: Baseline, 6 week(end of CRT), 6 months(following CRT)
Patient perception of swallowing ability
Time frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Quality of Life
Time frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
3 secondary outcomes
Taste perception
Time frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Perception of smell
Time frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
Salivation rates
Time frame: Baseline, 6 weeks (end of CRT), 6 months (following CRT)
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 20 Sep 2011.
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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.
Giselle Carnaby-Mann, PhD principal investigator
University of Florida
Michael Crary, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing focused attention sessions, Valchuff and Pharyngocise in people with Head & Neck Cancer, run by University of Florida 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 5 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 20 Sep 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Oropharyngeal muscle volume and signal intensity measured by T2 weighted MRI (time frame: Baseline, 6 weeks( end of CRT), 6 months(following CRT)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2011.