Head and Neck CancerNCT01053546
Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
A study testing exercise intervention, questionnaire administration and quality-of-life assessment in people with Head and Neck Cancer and Stage I Hypopharyngeal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy. PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Stage I Hypopharyngeal Cancer, Stage I Laryngeal Cancer
- What is being tested?
- exercise intervention, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2012
- 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
- Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
- Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
- Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
- Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
- Participants must be willing to participate in the swallowing exercise program
Who cannot join
- Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
- Previous radiation treatment for head/neck cancer
- Swallowing problem of etiology other than current lesion
- Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.
- Conditions
- Head and Neck Cancer, Stage I Hypopharyngeal Cancer, Stage I Laryngeal Cancer, Stage I Oropharyngeal Cancer, Stage II Hypopharyngeal Cancer, Stage II Laryngeal Cancer
- Being tested
- exercise intervention, questionnaire administration, quality-of-life assessment
- Medical subject headings
- Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
questionnaire administrationOther
Ancillary study
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary study
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Early exercise group) | Experimental | Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy. Receives: Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment |
| Arm II (Late exercise group) | Experimental | Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy. Receives: Behavioral: exercise intervention; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
Measured: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
Secondary outcomes (7)
Penetration Aspiration Scale (PAS) as assessed via FEES
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Feeding tube duration (days)
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Eating Assessment Tool (EAT) quality of life score
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Lingual strength as assessed by lingual manometry
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight loss
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight recovery
Measured: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: slow accrual
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 Wake Forest University Health SciencesThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Butler, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053546
- Sponsor's protocol ID
- IRB00010437
- Other IDs
- NCI-2009-01445, CCCWFU 98109
- Status last verified
- Jul 2018
- First submitted
- 20 Jan 2010
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01053546
- Acronym / sponsor ID
- IRB00010437
- Conditions
- Head and Neck Cancer, Stage I Hypopharyngeal Cancer, Stage I Laryngeal Cancer, Stage I Oropharyngeal Cancer, Stage II Hypopharyngeal Cancer, Stage II Laryngeal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jan 2010 (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.
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
Detailed description
PRIMARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
- To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Early exercise group) | Experimental | Behavioral: exercise intervention, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy. |
| Arm II (Late exercise group) | Experimental | Behavioral: exercise intervention, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
- Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
- Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
- Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
- Participants must be willing to participate in the swallowing exercise program
Key exclusion criteria (4 listed)
- Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
- Previous radiation treatment for head/neck cancer
- Swallowing problem of etiology other than current lesion
- Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
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 |
|---|---|---|
| exercise interventionThe early exercise group will start study exercises approximately two weeks prior to the onset of XRT. The late exercise group will start study exercises one month after the completion of XRT. Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments. | Behavioural | Arm I (Early exercise group), Arm II (Late exercise group) |
| questionnaire administrationAncillary study | Other | Arm I (Early exercise group), Arm II (Late exercise group) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary study | Procedure or surgery | Arm I (Early exercise group), Arm II (Late exercise group) |
Primary outcome
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
Time frame: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
7 secondary outcomes
Penetration Aspiration Scale (PAS) as assessed via FEES
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Feeding tube duration (days)
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Eating Assessment Tool (EAT) quality of life score
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Lingual strength as assessed by lingual manometry
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight loss
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Percent weight recovery
Time frame: Baseline and at 1, 3, and 6 months following completion of radiotherapy
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
Susan Butler principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, questionnaire administration and quality-of-life assessment in people with Head and Neck Cancer and Stage I Hypopharyngeal Cancer, run by Wake Forest University Health Sciences 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: stopped early, as of the sponsor's last update on 1 Aug 2018. 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 was stopped early (reason given: slow accrual). Results are not available in the source record.
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?
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score (time frame: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy). 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 1 Aug 2018.