Swallowing Initiation Training for Head and Neck Cancer-Related Swallowing Disorders

Recruiting at 1 trial location

Overseen By Bonnie Martin-Harris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Neurological disorders, Tracheostomy, NG tube, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with head and neck cancer who have difficulty swallowing. Researchers are testing a method called "Training Swallowing Initiation During Expiration," which trains participants to start swallowing while breathing out, potentially making swallowing safer and easier. The trial includes two groups: one practicing this new technique and another practicing regular swallowing. Individuals who completed cancer treatment at least three months ago and can swallow some liquids without assistance might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance swallowing safety and ease for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this swallowing treatment is safe for head and neck cancer-related swallowing disorders?

Research has shown that practicing swallowing while breathing out can help people who have trouble swallowing after head and neck cancer. Studies have found that this technique makes swallowing safer and more effective. No major safety issues have been reported with this method.

While detailed data from earlier studies is limited, participants generally accept this type of training. Being non-invasive and focused on improving a natural body function, it likely carries a low risk of serious side effects. Overall, this training might offer a safer option for those with swallowing difficulties. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new technique to help people with swallowing disorders due to head and neck cancer. Unlike traditional therapies that might focus on strengthening muscles or coordination, this method trains patients to initiate swallowing during expiration, which is the act of breathing out. This timing could optimize the swallowing process and reduce the risk of aspiration, making it a potentially safer and more effective approach. By targeting the respiratory-swallow phase, this technique offers a novel way to improve swallowing safety and efficiency, which could significantly enhance the quality of life for affected individuals.

What evidence suggests that this trial's treatments could be effective for head and neck cancer-related swallowing disorders?

This trial will compare two approaches for managing swallowing disorders in head and neck cancer survivors. Research has shown that teaching individuals to swallow while breathing out can make swallowing safer and more efficient. Participants in the "Respiratory-Swallow Phase Training" arm will learn to initiate swallowing during expiration, a method studies have found helps protect the airway and improve swallowing. Meanwhile, the "Swallow Practice" arm will involve practicing swallowing without the key therapeutic element of initiating swallowing during expiration. Early results suggest that swallowing during expiration could offer a new way to manage these swallowing problems. ^{1 2 3 4 5}

Who Is on the Research Team?

Bonnie Martin-Harris, PhD

Principal Investigator

Northwestern Memorial Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Tolerate wearing the sensor for at least 10 hours/day

I have swallowing difficulties confirmed by a specific test.

I have been diagnosed with cancer in my head or neck.

Exclusion Criteria

Indwelling tracheostomy tube

Known allergy to sensor adhesive

Known allergy to contrast materials or liquids used during the MBSS or training

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive respiratory-swallow phase training to improve swallowing safety and efficiency

12 weeks

Remote therapy sessions using telehealth platform

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 1-week, 1-month, and 3-months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Swallow Practice
• Training Swallowing Initiation During Expiration

Trial Overview 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.

How Is the Trial Designed?

Group I: Respiratory-Swallow Phase Training Experimental Treatment 1 Intervention

Participants will be trained to initiate swallowing during expiration.

Group II: Swallow Practice Placebo Group 1 Intervention

Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

Published Research Related to This Trial

A novel training intervention for patients with head and neck cancer improved swallowing safety and efficiency by teaching them to swallow during the midexpiratory phase of breathing, with significant improvements in respiratory-swallowing coordination (P<.0001).

Patients showed marked enhancements in swallowing-related measures, including laryngeal vestibular closure and tongue base retraction, as well as improved scores on the Penetration-Aspiration Scale, indicating better airway protection and bolus clearance after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory-swallow training in patients with head and neck cancer. Martin-Harris, B., McFarland, D., Hill, EG., et al.[2023]

In a study involving 240 head and neck cancer patients, early initiation of swallowing exercises and progressive resistance training during radiotherapy showed significant improvements in quality of life, depression, and anxiety at the 12-month follow-up compared to usual care.

However, the intervention did not significantly improve swallowing safety, indicating that while the exercises may enhance overall well-being, they may not directly address swallowing function in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. Hajdú, SF., Wessel, I., Dalton, SO., et al.[2022]

Dysphagia, or swallowing impairment, is a major issue for head and neck cancer patients, often persisting despite treatment and traditional therapies, leading to significant health challenges.

The respiratory-swallow treatment (RST) approach aims to improve swallowing by focusing on the coordination between breathing and swallowing, showing promise in clinical trials for patients with chronic dysphagia after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Respiratory-Swallowing Coordination in Patients With Oropharyngeal Head and Neck Cancer. Martin-Harris, B., Garand, KLF., McFarland, D.[2020]

In a study involving 45 head and neck cancer patients, adherence to a preventive swallowing exercise program was high, with a median adherence rate of 78%, although it fell slightly below the 80% threshold considered optimal.

No significant associations were found between adherence to the exercise program and factors such as HPV status, partner status, chemotherapy, or tumor site, suggesting that these factors may not influence patients' commitment to the exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. Hajdú, SF., Christensen, MB., Kristensen, MØ., et al.[2019]

In a study involving 44 head and neck cancer survivors, prophylactic swallowing exercises did not show any significant improvement in swallowing-related outcomes compared to standard care after radiotherapy.

Poor adherence to the swallowing exercises and high dropout rates due to fatigue were major challenges, indicating that even with supervision, patients struggled to maintain the exercise regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Swallowing Exercises in Head and Neck Cancer Radiotherapy. Mortensen, HR., Jensen, K., Aksglæde, K., et al.[2018]

Swallowing is most effective when it occurs during the expiratory phase of breathing, which helps protect the airway and facilitates important movements like laryngeal elevation and sphincter opening.

A newly developed training protocol has shown promising results in improving swallowing coordination with breathing in patients, particularly head and neck cancer survivors, leading to reduced swallowing impairments and enhanced airway protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-System Integration of Respiration and Deglutition: Function, Treatment, and Future Directions. Martin-Harris, B., Kantarcigil, C., Reedy, EL., et al.[2023]

In a study of 121 patients who underwent oral cancer surgery and free flap reconstruction, early swallowing training significantly improved swallowing function and nutritional status, as indicated by higher MASA-OC scores and better weight loss rates compared to the control group.

The intervention group also experienced a shorter time for nasogastric tube removal and improved quality of life, highlighting the benefits of early rehabilitation in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early swallowing training after free flap surgery in oral cancer: A randomized controlled trial. Wu, HY., Shan, XF., Cai, ZG., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4410058/

Respiratory-Swallow Training in Patients with Head and ... We have shown that HNC patients who tended to initiate swallowing by interrupting the inspiratory phase of the breathing cycle had greater severity of airway ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25498307/

Respiratory-swallow training in patients with head and neck ... A novel intervention to train swallowing to occur in the midexpiratory to low expiratory phase of quiet breathing to improve swallowing safety and efficiency.

3. trialx.com trialx.com/clinical-trials/listings/260764/training-swallowing-initiation-during-expiration/

Training Swallowing Initiation During Expiration - Dysphagia This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing ...

4. scsc.northwestern.edu scsc.northwestern.edu/investigations/2training-swallowing-initiation-during-expiration/

Training Swallowing Initiation during Expiration This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve ...

5. smartpatients.com smartpatients.com/trials/NCT05278039

Training Swallowing Initiation During Expiration This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to ...