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Swallowing Initiation Training for Head and Neck Cancer-Related Swallowing Disorders
N/A
Recruiting
Led By Bonnie Martin-Harris, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS
Diagnosis of primary head and neck cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Awards & highlights
Study Summary
This trial is investigating a new treatment for people who have trouble swallowing due to oropharyngeal head and neck cancers. The treatment involves training people to initiate swallowing during the expiratory phase of respiration, in order to improve swallowing safety and efficiency.
Who is the study for?
This trial is for English-speaking adults who've had head and neck cancer, are three months post-treatment, can swallow some liquids, and have a certain level of swallowing difficulty. They must pass a cognitive test and not have severe lung disease or allergies to materials used in the study. Pregnant individuals or those with recurrent cancer, drug abuse history, neurological disorders, feeding tubes, or tracheostomy tubes cannot participate.Check my eligibility
What is being tested?
The study tests a new therapy that trains patients to initiate swallowing during the expiratory phase (breathing out) to improve safety and efficiency in swallowing. Participants will undergo Respiratory-Swallow Phase Training combined with regular swallow practice.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing sensors for long periods or reactions related to practicing new swallowing techniques.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have swallowing difficulties confirmed by a specific test.
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I have been diagnosed with cancer in my head or neck.
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I can swallow liquid without needing special techniques.
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My lung function is not severely impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Penetration-Aspiration Scale scores
Change in frequency (%) of swallows initiated during expiration
Secondary outcome measures
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
Change in Normalized Residue Ratio Scale scores
Other outcome measures
Change in M.D. Anderson Dysphagia Inventory (MDADI) scores
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Respiratory-Swallow Phase TrainingExperimental Treatment1 Intervention
Participants will be trained to initiate swallowing during expiration.
Group II: Swallow PracticePlacebo Group1 Intervention
Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,163 Total Patients Enrolled
Northwestern Memorial HospitalOTHER
40 Previous Clinical Trials
16,628 Total Patients Enrolled
Bonnie Martin-Harris, PhDPrincipal InvestigatorNorthwestern Memorial Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swallowing difficulties confirmed by a specific test.I have been diagnosed with cancer in my head or neck.I can swallow liquid without needing special techniques.My cancer has come back or hasn't gone away.My vision and hearing work well with or without aids.I have been diagnosed with a neurological disorder.I have had aspiration pneumonia in the last year.I cannot take liquid medicine by myself.I struggle to swallow liquids without using special techniques.My lung function is not severely impaired.I finished my first cancer treatment over 3 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Respiratory-Swallow Phase Training
- Group 2: Swallow Practice
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this investigation?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting patients with the original posting date being May 19th 2022 and last updated on June 9th 2022. The study requires 88 participants from 2 sites for completion."
Answered by AI
How many participants are engaged in this clinical exploration?
"Affirmative. The details of the study published on clinicaltrials.gov suggest that recruitment is currently ongoing for this medical trial, which was initially posted on May 19th 2022 and recently updated June 9th 2022. 88 participants are needed to be enrolled at two different locations."
Answered by AI
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