Clinical trial · Interventional
Vibrent Smartphone Mobile Application
A Feasibility Study of the VibrentTM Smartphone App for Head & Neck Cancer Patients: Supporting Pain Management of Radiation-Induced Mucositis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being done to evaluate whether or not a customized version of the VibrentTM (formerly FitNinjaTM) mobile app is a feasible way to help people manage and control the pain from radiation sores (also referred to as "mucositis") when treating head and neck cancers with radiation. The mobile app will be designed to help people better understand the pain from the radiation sores and how to better use their medications especially when they are away from the hospital.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vibrogent Smartphone Application | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vibrent Smartphone Application
- description
- We propose to pilot the application of the mobile application "VibrentTM" (research procedure) during a course of head and neck radiotherapy for eligible study subjects. Study subjects will be prospective consented and enrolled and will have baseline "out of clinic" assessment with the Vibrent smartphone application (research procedure).
- interventionNames
- Other: Vibrogent Smartphone Application
Primary outcomes (1)
- measure
- Change from baseline in "out of clinic" pain at 2 months
- timeFrame
- 2 months
- description
- We hypothesize that the interactive VibrentTM algorithm can be adopted to extend the current "in clinic" prophylactic pain regimen for the management of radiation-induced mucositis to improve "out of clinic" adherence and the effectiveness of this regimen. Feasibility of the VibrentTM smartphone application will be defined by patient utilization rates and satisfaction scores.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Study subjects age ≥ 18 years of age. 2. Study subject with a Karnofsky performance scale of 80 or greater. 3. Study subjects capable of providing informed consent. 4. Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive or postoperative course of radiotherapy requiring a prescribed dose of radiation therapy 5. Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the VibrentTM software with sufficient monthly data plan (approximately 200 megabytes per month). Exclusion Criteria: a. No known hypersensitivity or intolerance to gabapentin.
References
Publications (0)
Data not yet available