Clinical trial · Interventional
Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
- 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)
The goals of this clinical trial are to learn 1. Determine the feasibility of a home-based exercise analog therapy using Transcutaneous Electrical Nerve Stimulation (TENS), 2. Determine the effects of exercise analog therapy on muscle mass, strength, and clinical outcomes, and 3. Determine the effects of exercise analog therapy on immune phenotype and inflammation response in patients undergoing radiation for head and neck squamous cell carcinoma (HNSCC). The main question it aims to answer are: Does an exercise regimen using an analog TENS unit during the course of cancer treatment for those with HNSCC improve muscle mass, strength, clinical outcomes and immune response compared to those that do not perform the exercise regimen during their cancer treatment? Researchers will compare outcomes of patients undergoing cancer treatment + TENS unit exercise to those being treated for their cancer with no exercise TENS unit. In the exercise arm, subjects will use the TENS unit for 30 minutes of exercise a day, 3 times a week for the extent of their cancer treatments. Weekly check-ins by phone or less frequently at scheduled in person visits. Participants will keep a log of their exercise sessions to make sure that the exercise occurs 3 times a week for 30 minutes each and note any reasons why a session may have been missed or time shortened. Both arms will have a blood draw at the beginning of their cancer treatment and approximately 4 weeks after the last cancer treatment (\~40mL). These samples will be tested for molecules that signal a higher or lower immune response with the addition of the exercise in one group compared to the cancer therapy only group.
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma HNSCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Cancer Treatment Only
- description
- Subjects will undergo their prescribed cancer treatment therapy (radiation/chemo/adjuvant)
- type
- EXPERIMENTAL
- label
- Cancer Treatment + Exercise TENS therapy
- description
- Subjects will undergo prescribed cancer therapy (chemo/radiation/adjuvant) with the addition of an at-home analog TENS unit exercise therapy regimen
- interventionNames
- Other: Exercise
Primary outcomes (1)
- measure
- Number of Patients that complete TENS unit exercise as recommended
- timeFrame
- beginning of cancer treatment to 4 weeks after cancer treatment concludes
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18 years or older) * Diagnosed with head and neck squamous cell carcinoma * HPV negative * Undergoing treatment at OLOL H\&N Center Exclusion Criteria: * Any subject less than 18 years of age. * Subjects who have HPV positive HNSCC * Subjects who have a pacemaker or electronic implant
References
Publications (0)
Data not yet available