Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOur Lady of the Lake Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18 years or older)
Diagnosed with head and neck squamous cell carcinoma
HPV negative
Undergoing treatment at OLOL H&N Center
Disqualifiers
Any subject less than 18 years of age.
Subjects who have HPV positive HNSCC
Subjects who have a pacemaker or electronic implant
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionPerform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cancer Treatment OnlyNo intervention 0 interventions
Group B: Cancer Treatment + Exercise TENS therapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
beginning of cancer treatment to 4 weeks after cancer treatment concludesSecondary outcomes
1
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.
Time frame
Once at beginning of cancer treatment and once 4 weeks post-cancer treatment2
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.
Time frame
Once prior to cancer treatment and once 4 weeks post treatment3
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
Time frame
Beginning of cancer treatment to 4 weeks post-cancer treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: