Head and Neck CancerNCT00584129
Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
A study testing Pre-treatment swallowing exercises and Post-treatment swallowing exercises. in people with Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pre-treatment swallowing exercises and Post-treatment swallowing exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III or IV squamous cell cancer of teh pharynx and larynx
- Patients who will be receiving chemoradiation
- Age 19 years of age or older
- Must sign informed consent.
Who cannot join
- Prior cancer diagnosis
- Metastatic disease
- Cognitive Impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Division of Otolaryngology
Birmingham, Alabama, 35294
About this study
Official title: Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.
- Conditions
- Head and Neck Cancer
- Being tested
- Pre-treatment swallowing exercises, Post-treatment swallowing exercises.
- Keywords
- Cancer, Dysphagia, Radiation, Patients with H&N cancer who will be receiving chemoradiation
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment swallowing exercisesOther
Swallowing exercises will be started pre-treatment with radiation.
Post-treatment swallowing exercises.Other
Patients to start swallowing exercises after completion of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive pre-treatment swallowing exercises. Receives: Other: Pre-treatment swallowing exercises |
| 2 | Active comparator | Post-treatment swallowing exercises. Receives: Other: Post-treatment swallowing exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.
Measured: 8 weeks, 6 months, 12 months post radiation treatment
Secondary outcomes (1)
To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
Measured: 8 weeks, 6 mnths and 12 months post radiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Responsible party
- Principal investigator, William Carroll, MD, University of Alabama at Birmingham
- Investigators
- William R. Carroll, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584129
- Sponsor's protocol ID
- F060123002
- Other IDs
- F060123002
- Status last verified
- Mar 2015
- First submitted
- 21 Dec 2007
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
- ClinicalTrials.gov ID
- NCT00584129
- Acronym / sponsor ID
- F060123002
- Conditions
- Head and Neck Cancer
- Keywords
- Cancer, Dysphagia, Radiation, Patients with H&N cancer who will be receiving chemoradiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- Feb 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jan 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.
The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Pre-treatment swallowing exercisesPatients will receive pre-treatment swallowing exercises. |
| 2 | Active comparator | Other: Post-treatment swallowing exercises.Post-treatment swallowing exercises. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage III or IV squamous cell cancer of teh pharynx and larynx
- Patients who will be receiving chemoradiation
- Age 19 years of age or older
- Must sign informed consent.
Key exclusion criteria (3 listed)
- Prior cancer diagnosis
- Metastatic disease
- Cognitive Impairment
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 |
|---|---|---|
| Pre-treatment swallowing exercisesSwallowing exercises will be started pre-treatment with radiation. | Other | 1 |
| Post-treatment swallowing exercises.Patients to start swallowing exercises after completion of radiation therapy. | Other | 2 |
Primary outcome
To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.
Time frame: 8 weeks, 6 months, 12 months post radiation treatment
1 secondary outcome
To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
Time frame: 8 weeks, 6 mnths and 12 months post radiation.
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 17 Mar 2015.
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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.
William R. Carroll, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-treatment swallowing exercises and Post-treatment swallowing exercises. in people with Head and Neck Cancer, run by University of Alabama at Birmingham 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 4 inclusion and 3 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 17 Mar 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?
To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer. (time frame: 8 weeks, 6 months, 12 months post radiation treatment). 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 17 Mar 2015.