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

Trial Summary

What is the purpose of this trial?

This trial tests a new method that teaches head and neck cancer survivors to swallow while exhaling. This approach aims to make swallowing safer and more efficient for those who have trouble swallowing after their cancer treatment.

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.

Is Swallowing Initiation Training safe for humans?

The research on swallowing exercises and respiratory-swallow training for head and neck cancer patients suggests that these interventions are generally safe, with no significant safety concerns reported in the studies. However, adherence to the exercises can be challenging, and some participants experienced fatigue. ^{1 2 3 4 5}

How is the Swallowing Initiation Training for head and neck cancer-related swallowing disorders different from other treatments?

This treatment is unique because it focuses on retraining the coordination between breathing and swallowing, specifically teaching patients to swallow during the exhalation phase of breathing, which can improve swallowing safety and efficiency. Unlike traditional therapies that target only the muscles involved in swallowing, this approach aims to restore the natural timing between breathing and swallowing, offering potential benefits for patients with chronic swallowing difficulties after head and neck cancer treatment. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Swallow Practice, Respiratory-Swallow Phase Training, and Swallowing Initiation During Expiration for head and neck cancer-related swallowing disorders?

Research shows that training to coordinate swallowing with breathing can improve swallowing safety and efficiency in head and neck cancer patients. This approach helps protect the airway and enhances swallowing function, which is crucial for patients with swallowing difficulties after cancer treatment. ^{1 2 5 6 7}

Research Team

Bonnie Martin-Harris, PhD

Principal Investigator

Northwestern Memorial Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimizing Respiratory-Swallowing Coordination in Patients With Oropharyngeal Head and Neck Cancer. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Respiratory-swallow training in patients with head and neck cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cross-System Integration of Respiration and Deglutition: Function, Treatment, and Future Directions. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Early swallowing training after free flap surgery in oral cancer: A randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Prophylactic Swallowing Exercises in Head and Neck Cancer Radiotherapy. [2018]