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

NCT06839014 | Not Yet Recruiting

• 1 other identifier: IRB#8333_Kansara Exer Therapy
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

Exercise Therapy; TENS Unit Therapy; Exercise and Cancer; Exercise and Immune Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• Percent Fat/Water/Muscle Content of Body

  Once prior to cancer treatment and once 4 weeks post treatment

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

  Beginning of cancer treatment to 4 weeks post-cancer treatment

Study Arms (2)

Cancer Treatment Only

NO INTERVENTION

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

Cancer Treatment + Exercise TENS therapy

EXPERIMENTAL

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

Other: Exercise

Interventions

Exercise OTHER

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

Cancer Treatment + Exercise TENS therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or older)
• Diagnosed with head and neck squamous cell carcinoma
• HPV negative
• Undergoing treatment at OLOL H\&N Center

You may not qualify if:

• Any subject less than 18 years of age.
• Subjects who have HPV positive HNSCC
• Subjects who have a pacemaker or electronic implant

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christine Lebeouf Leboeuf, DNP

  Our Lady of the Lake Hospital

  STUDY DIRECTOR

Central Study Contacts

Sagar Kansara, MD

CONTACT

225-765-1765; skans1@lsuhsc.edu

Leslis Son, PhD

CONTACT

225-362-2884; Lson@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share