Skip to main content
OpenTrials
Completed

NCT Number: NCT03832686

Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cancer Institute, Palo Alto, California, United States

Loading trial locations.

About this study

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has recently seen a dramatic rise in the United States due to a rise in the incidence of oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients diagnosed with HNC receive radiation therapy at some point in their treatment, either in the definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC, experienced by approximately 50% of patients treated with radiation therapy. Post-treatment dysphagia has been associated with increased risk of morbidity/mortality as well as well-recognized deterioration of quality of life. Performance of swallowing exercises during radiation significantly reduces dysphagia risk; however, patient adherence to swallowing exercises during radiation treatment is limited. Thus, poor adherence stands as a major obstacle to achieving the best swallowing outcomes. In response to this, a mobile health application was developed to directly address barriers cited by patients as reasons for non-adherence. The objective is to conduct a randomized controlled trial to test the impact of the mobile application on adherence to prophylactic swallowing therapy during radiation for HNC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Study subjects ≥ 18 years of age.
  • Fluent English speaking subjects.
  • Study subjects capable of providing informed consent.
  • Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck radiation. Individuals with unknown primary head and neck cancer with nodal disease necessitating bilateral radiation will also be included.
  • Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater.
  • Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the Vibrent application.
  • Study subjects who have access to a sufficient monthly data plan (approximately 200 MB/month), or Internet connection.

Exclusion criteria

  • Non-English speaking, or incapable of providing informed consent.
  • Lack of smartphone, tablet, or Internet connection.
  • Inability to use the Vibrent application.
  • Patients being treated for head and neck cancer who do not receive some form of primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the study.
  • Patients with recurrent disease.
  • Pregnant women.
  • Individuals under the age of 18.
  • Individuals with contraindications to radiation therapy.

Treatment and study plan

Virtual Coach

Other

The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.

Primary outcomes

  1. Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises

    Time frame: 7 weeks

    Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.

Secondary outcomes

  1. Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)

    Time frame: 19 weeks

    The MD Anderson Dysphagia Inventory (MDADI) was selected to capture and quantify the patient perception of swallowing dysfunction. It is a 20-item patient reported survey that measures the impact of dysphagia on patients with HNC. Each item is scored on a 5 point scale with 1=lower function and 5=higher function. Possible scores range from 20-100 with higher scores indicating more normal swallowing function.

  2. Diet Level as Defined by the Functional Oral Intake Scale (FOIS)

    Time frame: 19 weeks

    Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 where lower scores reflect more limited oral intake and higher scores reflect more normal diet levels.

  3. Diet Restrictions as Measured by the Performance Status Scale Head and Neck

    Time frame: 7 weeks

    Performance Status Scale Head and Neck measures eating in public (range 0-100; higher number is indicative of better function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)

  4. Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)

    Time frame: 19 weeks

    The Modified Barium Swallow Impairment Profile is a tool designed to quantify degree of impairment on 13 individual physiologic components visualized during a modified barium swallow where higher numbers reflect greater dysfunction. Score range: 0-4 for each physiologic component. The maximum possible Oral score is 22 and the maximum possible pharyngeal score is 29.

  5. Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)

    Time frame: 19 weeks

    The Penetration Aspiration Scale measures the presence and depth of food/liquid material entering the airway and patient response to that material. This scale ranges from 1-8 with higher numbers indicating more abnormal function.

  6. Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale

    Time frame: 7 weeks

    Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) rates the safety and efficiency of the swallow. Safety and efficiency are rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale also includes an overall impairment score which takes into consideration the safety and efficiency grade.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 6, 2019
Registry last updated
Apr 10, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.