N/A
N=91
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Head Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03832686 ↗Enrolled (actual)
91
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises — 18; 17; 19; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Coach (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises |
18; 17; 19; 16; 15; 13 | — |
| SECONDARY Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI) |
75.66; 76.35 | 0.86 |
| SECONDARY Diet Level as Defined by the Functional Oral Intake Scale (FOIS) |
6.06; 5.94 | 0.69 |
| SECONDARY Diet Restrictions as Measured by the Performance Status Scale Head and Neck |
90.15; 86.12; 79.12; 76.94 | 0.47 |
| SECONDARY Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP) |
3.9; 4.21; 9.33; 8.18 | 0.65 |
| SECONDARY Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS) |
2.76; 2.42 | 0.53 |
| SECONDARY Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale |
0.97; 0.82 | 0.50 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03832686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.