Head and Neck Squamous Cell Carcinoma HNSCCNCT06839014
Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
A study testing Exercise in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Our Lady of the Lake Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or older)
- Diagnosed with head and neck squamous cell carcinoma
- HPV negative
- Undergoing treatment at OLOL H\&N Center
Who cannot join
- Any subject less than 18 years of age.
- Subjects who have HPV positive HNSCC
- Subjects who have a pacemaker or electronic implant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
- Being tested
- Exercise
- Keywords
- Exercise Therapy, TENS Unit Therapy, Exercise and Cancer, Exercise and Immune Response
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Perform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: beginning of cancer treatment to 4 weeks after cancer treatment concludes
Secondary outcomes (3)
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.
Measured: Once at beginning of cancer treatment and once 4 weeks post-cancer treatment
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.
Measured: Once prior to cancer treatment and once 4 weeks post treatment
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
Measured: Beginning of cancer treatment to 4 weeks post-cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Lebeouf Leboeuf, DNP, Study director, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839014
- Sponsor's protocol ID
- IRB#8333_Kansara Exer Therapy
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT06839014
- Acronym / sponsor ID
- IRB#8333_Kansara Exer Therapy
- Keywords
- Exercise Therapy, TENS Unit Therapy, Exercise and Cancer, Exercise and Immune Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Treatment Only | No intervention | –Subjects will undergo their prescribed cancer treatment therapy (radiation/chemo/adjuvant) |
| Cancer Treatment + Exercise TENS therapy | Experimental | Other: ExerciseSubjects will undergo prescribed cancer therapy (chemo/radiation/adjuvant) with the addition of an at-home analog TENS unit exercise therapy regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years or older)
- Diagnosed with head and neck squamous cell carcinoma
- HPV negative
- Undergoing treatment at OLOL H\&N Center
Key exclusion criteria (3 listed)
- Any subject less than 18 years of age.
- Subjects who have HPV positive HNSCC
- Subjects who have a pacemaker or electronic implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePerform 30 minutes of TENS unit exercise muscle stimulation each day for 3 days a week for the duration of cancer treatment. | Other | Cancer Treatment + Exercise TENS therapy |
Primary outcome
Number of Patients that complete TENS unit exercise as recommended
Time frame: beginning of cancer treatment to 4 weeks after cancer treatment concludes
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Lebeouf Leboeuf, DNP study director
Our Lady of the Lake Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by Our Lady of the Lake Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sagar Kansara, MD (225-765-1765, skans1@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients that complete TENS unit exercise as recommended (time frame: beginning of cancer treatment to 4 weeks after cancer treatment concludes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.