NCT06839014

Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Our Lady of the Lake Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Head and Neck Squamous Cell Carcinoma HNSCC

Interventions

Type	Name	Description
OTHER	Exercise	Perform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-21
• Last updated: 2025-02-25