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Respiratory Swallow Training for Swallowing Disorders in Head and Neck Cancer
N/A
Waitlist Available
Led By Bonnie J. Martin-Harris, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 60 days, 120 days, 240 days
Awards & highlights
Study Summary
This trial is testing a new swallowing treatment approach to improve swallowing function in Veterans with swallowing impairment following treatment for head and neck cancer.
Who is the study for?
This trial is for Veterans and non-Veterans over 21 who've had treatment for head and neck cancer, are at least 6 months post-treatment, still have trouble swallowing despite past therapy, can speak English, and pass a cognitive test. It's not for those with severe lung disease (COPD), heavy alcohol use, recent pneumonia from aspiration or allergies to contrast materials used in the study.Check my eligibility
What is being tested?
The study tests respiratory-swallow training (RST) against standard care to see if it improves eating, drinking, health outcomes and quality of life after head and neck cancer treatments. Participants will be randomly assigned to either RST or standard care groups.See study design
What are the potential side effects?
Specific side effects aren't detailed but may include discomfort during exercises or potential risks associated with swallowing assessments using contrast materials.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 days, 60 days, 120 days, 240 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 60 days, 120 days, 240 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MBSImP physiologic function metrics of the oropharyngeal swallow
Secondary outcome measures
Functional Oral Intake Scale (FOIS)
Erythrocyte Indices
Penetration Aspiration scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RSTExperimental Treatment1 Intervention
Respiratory Swallow Training Arm
Group II: Standard of CareActive Control1 Intervention
Standard of Care Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Respiratory Swallow Training
2018
N/A
~40
Find a Location
Who is running the clinical trial?
Edward Hines Jr. VA HospitalFED
14 Previous Clinical Trials
1,742 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,389 Total Patients Enrolled
Bonnie J. Martin-Harris, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had pneumonia caused by inhaling food or liquid into your lungs within the past year.You have an allergy or dietary restriction that prevents you from consuming certain liquids or contrast materials used during the medical test or training.You are currently drinking more than two alcoholic drinks per day.You have difficulty swallowing liquids without choking or inhaling them into your lungs.You have been receiving treatment for difficulty swallowing for at least 6 months, but your swallowing problem has not improved.You have severe chronic obstructive pulmonary disease (COPD).
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: RST
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many individuals are taking part in this research project?
"Affirmative, according to clinicaltrials.gov this investigation is actively recruiting volunteers. It was initially posted on October 1st 2018 and underwent its latest edit on June 10th 2022. The trial aims to enrol 99 participants at a single site."
Answered by AI
Is this research endeavor currently entertaining any new participants?
"Yes, according to clinicaltrials.gov, this research is actively recruiting participants – the trial was originally advertised on October 1st 2018 and revised most recently on June 10th 2022. The study requires 99 people across a single location for participation."
Answered by AI
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