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

NCT ID: NCT06839014

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-31

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.

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cancer Treatment Only

Subjects will undergo their prescribed cancer treatment therapy (radiation/chemo/adjuvant)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Our Lady of the Lake Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Lebeouf Leboeuf, DNP

Role: STUDY_DIRECTOR

Our Lady of the Lake Hospital

Central Contacts

Sagar Kansara, MD

Role: CONTACT

skans1@lsuhsc.edu

225-765-1765

Leslis Son, PhD

Role: CONTACT

Lson@lsuhsc.edu

225-362-2884

Other Identifiers

IRB#8333_Kansara Exer Therapy

Identifier Type: -

Identifier Source: org_study_id