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

Our Lady of the Lake Hospital

Status: Not yet enrolling

Conditions: Head and Neck Squamous Cell Carcinoma HNSCC

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06839014

IRB#8333_Kansara Exer Therapy

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cancer Treatment Only

No Intervention group

Description:

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

Cancer Treatment + Exercise TENS therapy

Experimental group

Description:

Subjects will undergo prescribed cancer therapy (chemo/radiation/adjuvant) with the addition of an at-home analog TENS unit exercise therapy regimen

Treatment:

Other: Exercise