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NCT Number: NCT06839014

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Behavior Motor Activity Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Number of Patients that complete TENS unit exercise as recommended

    Time frame: beginning of cancer treatment to 4 weeks after cancer treatment concludes

    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.

Secondary outcomes

  1. Body Mass Index (BMI)=Weight (kg)/Height (m)^2

    Time frame: Once at beginning of cancer treatment and once 4 weeks post-cancer treatment

    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.

  2. Percent Fat/Water/Muscle Content of Body

    Time frame: Once prior to cancer treatment and once 4 weeks post treatment

    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.

  3. Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL)

    Time frame: Beginning of cancer treatment to 4 weeks post-cancer treatment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Leslis Son, PhD

CONTACT

[email protected]

225-362-2884

Sagar Kansara, MD

CONTACT

[email protected]

225-765-1765

Sponsors and collaborators

Lead sponsor

Our Lady of the Lake Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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