Clinical trial NCT06839014: Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title: Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma HNSCC
Keywords: Exercise Therapy
TENS Unit Therapy
Exercise and Cancer
Exercise and Immune Response
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients that complete TENS unit exercise as recommended
timeFrame: beginning of cancer treatment to 4 weeks after cancer treatment concludes
Secondary outcomes:
measure: Body Mass Index (BMI)=Weight (kg)/Height (m)^2
timeFrame: Once at beginning of cancer treatment and once 4 weeks post-cancer treatment
measure: Percent Fat/Water/Muscle Content of Body
timeFrame: Once prior to cancer treatment and once 4 weeks post treatment
measure: Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL)
timeFrame: Beginning of cancer treatment to 4 weeks post-cancer treatment
Other outcomes:
Locations:
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Christine Lebeouf Leboeuf, DNP
role: STUDY_DIRECTOR
References: