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Completed

NCT Number: NCT03435471

Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer

Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises.

The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy.

The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants.

All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
  • Scheduled to undergo definitive chemoradiation therapy
  • At least 18 years of age or older
  • Subject must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Surgical management in addition to chemoradiation therapy;
  • Cancer of the sinus, brain, or parotid;
  • Prior treatment for head and neck cancer;
  • Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
  • Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
  • Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
  • History of prior c-spine surgery;
  • History of prior vocal fold immobility

Treatment and study plan

Prophylactic Swallowing Home Exercise Program

Other

The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.

Clinician-Directed Prophylactic Swallowing Exercises

Other

Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises

Primary outcomes

  1. Change in swallowing status

    Time frame: Baseline, Up to 6 weeks

    Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).

Secondary outcomes

  1. Change in swallowing status as measured by FOIS

    Time frame: Baseline, Up to 30 weeks

    FOIS has a range from 0 (most restrictive) to 7 (least restrictive).

  2. Change in quality of life as measured by PSS-HN

    Time frame: Baseline to 6 weeks, Baseline to 30 weeks

    Performance Status Scale - Head and Neck (PSS-HSN) is a questionnaire with a total score ranging from 100 (normal function) to 0 (limited function).

  3. Change in quality of life as measured by EAT-10

    Time frame: Baseline to 6 weeks, Baseline to 30 weeks

    Eating Assessment Tool-10 (EAT-10) is a questionnaire with a total score ranging from 0 to 40 with the lower score indicating better function.

  4. Change in quality of life as measured by UW-QOL

    Time frame: Baseline to 6 weeks, Baseline to 30 weeks

    University of Washington Quality of Life (UW-QOL) is a questionnaire with a total score ranging from 0 to 100 with the higher score indicating poorer health outcomes.

  5. Proportion of patients requiring further swallowing therapy

    Time frame: Baseline to 6 weeks, Baseline to 30 weeks

    Proportion of patients requiring further swallowing therapy post study intervention as per treating physician discretion

  6. Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade

    Time frame: Baseline to 6 weeks, Baseline to 30 weeks

    DIGEST is a measure of pharyngeal swallowing efficiency and safety. The DIGEST measure incorporates 2 measures:

    • Safety as determined by the Penetration Aspiration Scale with a score ranging from 0 (safe) to 4 (life-threatening unsafe); and
    • Efficiency as determined by the quantity of residue observed on the videoflouroscopic swallowing study with a score ranging from 0 (efficient) to 4 (life-threatening inefficiency).

    These two measures combine for an overall score, ranging from 0 (no pharyngeal dysphagia) to 4 (life-threatening dysphagia).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 19, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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