Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma HNSCC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Exercise
Perform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.
Primary outcome measures
- Number of Patients that complete TENS unit exercise as recommended [Time frame: beginning of cancer treatment to 4 weeks after cancer treatment concludes]
Secondary outcome measures (3)
- Body Mass Index (BMI)=Weight (kg)/Height (m)^2 [Time frame: Once at beginning of cancer treatment and once 4 weeks post-cancer treatment]
- Percent Fat/Water/Muscle Content of Body [Time frame: Once prior to cancer treatment and once 4 weeks post treatment]
- Levels/Amount of Immunophenotypic Molecules from Blood Diagnostics (pg/mL) [Time frame: Beginning of cancer treatment to 4 weeks post-cancer treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06839014 · IRB#8333_Kansara Exer Therapy