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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma HNSCC
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sagar Kansara, MD; Phone Number: 225-765-1765; Email: skans1@lsuhsc.edu
• Study Contact Backup: Name: Leslis Son, PhD; Phone Number: 225-362-2884; Email: Lson@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Cancer Treatment Only; Subjects will undergo their prescribed cancer treatment therapy (radiation/chemo/adjuvant)
Experimental: Cancer Treatment + Exercise TENS therapy; Subjects will undergo prescribed cancer therapy (chemo/radiation/adjuvant) with the addition of an at-home analog TENS unit exercise therapy regimen	Other: Exercise; Perform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients that complete TENS unit exercise as recommended	The documentation of successful completion of exercise with the recommended use guidelines (30min, 3 times a week for duration of cancer therapy) will determine if using this type of low maintenance analog exercise muscle stimulation is practical for use in this patient population.	beginning of cancer treatment to 4 weeks after cancer treatment concludes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)=Weight (kg)/Height (m)^2	Body Mass Index using Height (m) vs Weight (kg) to calculate the BMI once pre cancer treatment and once post cancer treatment/intervention. BMI=Weight (kg)/Height (m)^2. This will identify what the effect of this analog exercise may have on the subject's BMI.	Once at beginning of cancer treatment and once 4 weeks post-cancer treatment
Percent Fat/Water/Muscle Content of Body	The Fat/Water/Muscle content ratio will be measured in both the control group and the exercise group prior to beginning cancer treatment with our without exercise and then 4 weeks post-treatment using Bioelectrical Impedance Analysis (a scale that a person stands on that measures body content ratios (%) of these three macromolecules). This measurement will also identify the effect of using the TENS unit analog exercise regimen on a subject's overall body composition.	Once prior to cancer treatment and once 4 weeks post treatment
Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL)	Immune response markers identified in the blood samples taken prior to cancer treatment and post treatment (exercise therapy occurring throughout this timeframe) will determine if the inclusion of this TENS unit exercise increases or decreases an immune response. The molecules identified will be measured in pg/mL	Beginning of cancer treatment to 4 weeks post-cancer treatment

Collaborators and Investigators

• Sponsor: Our Lady of the Lake Hospital
• Investigators: Study Director: Christine Lebeouf Leboeuf, DNP, Our Lady of the Lake Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise Therapy; TENS Unit Therapy; Exercise and Cancer; Exercise and Immune Response
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: IRB#8333_Kansara Exer Therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No