CLINICAL TRIAL

Respiratory-Swallow Phase Training for Head and Neck Cancer

Recruiting · 18+ · All Sexes · Chicago, IL

Training Swallowing Initiation During Expiration

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About the trial for Head and Neck Cancer

Eligible Conditions
Head and Neck Cancer · Head and Neck Neoplasms · Dysphagia · Oropharynx Squamous Cell Carcinoma · Deglutition Disorders · Oropharyngeal Dysphagia (OPD)

Treatment Groups

This trial involves 2 different treatments. Respiratory-Swallow Phase Training is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Respiratory-Swallow Phase Training
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Swallow Practice
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
New diagnosis of primary oropharyngeal head and neck cancer
Within 3-6 months post-completion of first-line cancer treatment
Pass cognitive screen (score ≥26 on Montreal Cognitive Assessment)
English speaking
Functional/corrected visual and hearing acuity
Non-smoking
No current alcohol or other drug abuse
You have COPD based on Pulmonary Function Testing (PFT). show original
No skin allergy to the medical-grade sensor adhesive
You tolerate wearing the sensor for at least 10 hours/day.\n show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Respiratory-Swallow Phase Training will improve 2 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Head and Neck Cancer. Measurement will happen over the course of Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 20 to 100 and higher scores indicate worse outcome..

Change in M.D. Anderson Dysphagia Inventory (MDADI) scores
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 20 TO 100 AND HIGHER SCORES INDICATE WORSE OUTCOME.
Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 20 TO 100 AND HIGHER SCORES INDICATE WORSE OUTCOME.
Change in Penetration-Aspiration Scale scores
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 1-8 AND HIGHER SCORES INDICATE WORSE OUTCOME.
Measures presence, depth and reaction to penetration and aspiration.
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 1-8 AND HIGHER SCORES INDICATE WORSE OUTCOME.
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. ORAL TOTAL SCORES RANGE FROM 0-22 AND PHARYNGEAL TOTAL SCORES RANGE FROM 0-26 AND HIGHER VALUES INDICATE WORSE OUTCOME.
Measures physiologic swallowing impairment from observations of MBSS recordings
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. ORAL TOTAL SCORES RANGE FROM 0-22 AND PHARYNGEAL TOTAL SCORES RANGE FROM 0-26 AND HIGHER VALUES INDICATE WORSE OUTCOME.
Change in Normalized Residue Ratio Scale scores
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 0 TO 100% AND HIGHER SCORES INDICATE WORSE OUTCOME.
Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT, 1-MONTH POST-TREATMENT, AND 3-MONTHS POST TREATMENT. SCORES RANGE FROM 0 TO 100% AND HIGHER SCORES INDICATE WORSE OUTCOME.
Change in frequency (%) of swallows initiated during expiration
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT AND 2-4-6-8-10-12-WEEKS POST-TREATMENT.
Determines percent (frequency) of the target (expiratory phase) for each swallow.
CHANGE FROM BASELINE TO 1-WEEK POST-TREATMENT AND 2-4-6-8-10-12-WEEKS POST-TREATMENT.

Who is running the study

Principal Investigator
B. M.
Prof. Bonnie Martin-Harris, Professor
Northwestern University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get head neoplasms a year in the United States?

A quarter of all newly diagnosed cancer cases in the United States in 2019 were attributable to head and neck cancer, making it the second most common cause of cancer-related death in this population and the most common cancer in a male individual. The majority of head and neck cancer cases occurring in the United States are attributable to tobacco use.

Anonymous Patient Answer

What are the signs of head neoplasms?

The clinical presentation of head neoplasms is often nonspecific as the physical manifestations cannot be explained by the anatomical position of the tumor. Nonsense is a sign of frontal lobe neoplasms as may be associated with cognitive impairment.

Anonymous Patient Answer

What are common treatments for head neoplasms?

The treatments are surgery and radiotherapy. In addition, if the cancer has metastasized to the bone, it needs to be removed and the person is put on a bone-loss medication to prevent bone collapse.

Anonymous Patient Answer

Can head neoplasms be cured?

Surgical treatment for benign or premalignant head and neck neoplasms can improve patient quality of life and in certain cases produce long-term cure. This treatment has no impact on disease-free survival, which remains a parameter of the natural history of head and neck cancer.

Anonymous Patient Answer

What causes head neoplasms?

The cause of head neoplasms is multifactorial, and an integrated approach is needed. The most reliable data exist on the effect of environmental factors which are controllable in the environment on an individual. Current evidence suggests that cigarette smoking has the greatest effect on the development of head cancer, although other environmental factors may have a significant effect, and specific pathogenic mechanisms may exist. Smoking should be the primary target for eliminating head cancer, and other causative factors, such as occupational exposures, radiation levels and diet, should be excluded during treatment planning.

Anonymous Patient Answer

What is head neoplasms?

The most common primary location of origin for human head tumors is the brain; this includes gliomas, medulloblastomas, and ependymomas. The most common location of primary tumor in the head is the frontal lobe, followed by the parietal lobe. The most common type of glioma in the brain is the [glioblastoma multiforme](https://www.withpower.com/clinical-trials/glioblastoma-multiforme) (GBM)— the malignant form of glioma. A glioblastoma is a tumor which makes the cortex of the brain unusable when it destroys and infiltrates surrounding normal brain tissue. In this article, the terms glioma and GBM are used interchangeably. Glioma: the tumor which is the origin of the tumor.

Anonymous Patient Answer

Is respiratory-swallow phase training typically used in combination with any other treatments?

When SRS was used in addition to any other treatment, this procedure was significantly better than no treatment, or any treatment other than SRS alone. In addition to the high effectiveness of SRS when used alone, our data highlight the fact that SRS is best used in combination with other treatments to avoid side effects.

Anonymous Patient Answer

Does respiratory-swallow phase training improve quality of life for those with head neoplasms?

Although head and neck cancers can have poor prognosis, treatment modalities including surgery have generally resulted in long-term survival. Respiratory-swallow phase training is of benefit for patients with head and neck cancers, resulting in improved quality of life.

Anonymous Patient Answer

Have there been any new discoveries for treating head neoplasms?

There has been a tremendous interest in head neoplasms, particularly [brain tumors] because they present a challenge in radiochemotherapy due to their complex growth. A deeper appreciation of tumor biology should help in the development of newer treatment strategies and hopefully lead to a future change in the current practice.

Anonymous Patient Answer

What is the primary cause of head neoplasms?

Adenomatous and neurofibrous tumors are the most common head and neck cancers, representing 36% (27/78) and 15% (11/74) of all head neoplasms, respectively. This information may assist in both directing patient care and evaluating treatment effectiveness.

Anonymous Patient Answer

How quickly does head neoplasms spread?

There are other causes of neoplasm dissemination. In this case the following hypotheses were tested: the presence of metastases (brain); size and site of the primary tumor as a key prognostic factor; adjuvant therapy efficacy and time from surgery and definitive therapy.

Anonymous Patient Answer

What are the latest developments in respiratory-swallow phase training for therapeutic use?

This work represents an important stage in the realization of a comprehensive medical equipment for the respiratory swallowing treatment phase training (RST). This medical equipment allows the patients to take the therapeutic swallow with greater confidence.

Anonymous Patient Answer
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