Head and Neck NeoplasmNCT04679233
Feasibility and Safety of Aerobic Exercise for Head and Neck Cancer Patients
A study testing Prescription aerobic exercise in people with Head and Neck Neoplasm and Radiotherapy, run by Vanderbilt University at 1 site in United States.
Trial summary
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Neoplasm, Radiotherapy
- What is being tested?
- Prescription aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Histologic proof of primary diagnosis of head and neck cancer
- Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months)
- Ability to understand English in order to understand instructions and complete questionnaires
- Willing to participate in the supervised exercise intervention
- In the planning stages of/or actively receiving IMRT
- Must sign study-specific informed consent
- Medical clearance by attending physician
Who cannot join
- Evidence of distant metastasis prior to enrollment
- Simultaneous primaries or unknown primary
- Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities
- An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).
Read the detailed description
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients, is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis.
Based on the evidence, the aerobic exercise prescription for those who provide informed consent will consist of 10 intervals of intensity, and 10 intervals at rest. Each interval of intensity will be 1 minutes long and each rest period will be 1 minute long, and there will be a five-minute warm-up and five-minute cool down of easy pedaling for a total of 30 minutes. Participants will complete two sessions per week, and there will be at least one business day in between each session, for a total of 10 total exercise sessions. The total study duration will be less than 35 days.
The supervised prescribed HIIE intervention will be performed on a stationary cycle ergometer. A cycle ergometer is preferred for safety reasons since it requires less gross motor coordination than might be required with a treadmill. To assist in establishing safety (primary aim), the study participants heart rate will be continually monitored by a clinician during the exercise, guiding them to keep their heart rate within their specifically calculated 80-95% of their maximum HR during the periods of intensity.
The investigators will compare outcomes at baseline with outcomes at the end of the 5-week study period.
- Conditions
- Head and Neck Neoplasm, Radiotherapy
- Being tested
- Prescription aerobic exercise
- Keywords
- Head and Neck Neoplasm, Radiotherapy, Exercise
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription aerobic exerciseOther
high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention Arm | Experimental | Arm 1 will receive the aerobic prescription exercise intervention. As this is a feasibility and safety study, there will not be a second arm. Receives: Other: Prescription aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Feasibility Log of Recruitment of Participants
To assess the feasibility of recruitment of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include qualitative information regarding noted barriers to recruitment and reasons for patients not participating
Measured: 6 months
Quantified and Qualitative Log of Feasibility of Implementation
To investigate the feasibility of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include reasons that participants may have missed any of their assigned exercise sessions, as well as how many times they missed it.
Measured: 6 months
Quantified and Qualitative Retention Log of Participants
To assess retention of a prescribed HIIE aerobic exercise modality for HNC patient. This will be measured by a Researchers Log which will include information such as number of participants enrolled, number of participants who dropped out, and reason for drop-out if available
Measured: 6 months
Safety of the intervention as noted by parameters for serum bloodwork
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log to ensure predetermined labs and electrolytes (platelets, magnesium, phosphorus, potassium) are within study parameter limits each week.
Measured: 6 months
Safety of the intervention as noted by parameters for vitals signs prior to participation
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include ensuring vitals signs (heart rate in beats per minute, blood pressure in mmHg, oxygen in saturation, respiration rate in rate per minutes, and temperature in celsius) are within study parameter limits
Measured: 6 months
Safety of the intervention as noted by a timely log of adverse events,
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include information such as measured by the CTCAE adverse events reported in accordance with and to the IRB
Measured: 6 months
Secondary outcomes (8)
Feasibility of Collecting Bloodwork - Biomarker MMP-9
To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: MMP-9. This will be measured as a blood draw, measured as ng/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time.
Measured: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6
To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: IL-6. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time.
Measured: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1β
To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: IL-1β. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time.
Measured: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-α
To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: TNF-α. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time.
Measured: 6 months
Feasibility of Collecting Bloodwork at two time points - TGF-β1
To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: TGF-β1. This will be measured as a blood draw, measured as ng/mL. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time.
Measured: 6 months
Feasibility of Collecting Patient Reported Outcome at two time points
To establish the feasibility of collecting the following outcome during the supervised prescribed HIIE regiment: LEF-related patient reported symptoms. The measurement tool to be used will be a validated a reliable patient reported outcome tool called the Lymphedema Symptom Inventory Distress Screening (LSIDS). Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of LSIDS questionnaires completed in full.
Measured: 6 months
Feasibility of Clinician Outcome at two time points
To establish the feasibility of collecting the following outcome during the supervised prescribed HIIE regiment: External Swelling LEF. The measurement tool to be used will be a standardized, validated, and reliable digital photography technique. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of digital photographs were able to be collected at prescribed time. Those with < 80% completed will be categorized as "no"
Measured: 6 months
Qualitative data on Patient Experience
To gather preliminary feedback on the impact of a supervised prescribed HIIE regimen on patient perceived experience of the weekly exercise program as they undergo treatment via the measurement instrument of a personal and de-identified patient journal with self guided questions for patients to respond to open-endedly. This is to be analyzed qualitatively via qualitative content analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: PI has withdrawn from the program, the study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-test, post-test feasibility and safety study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Bethany Rhoten, PhD, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679233
- Sponsor's protocol ID
- 201579
- Status last verified
- Feb 2022
- First submitted
- 25 Nov 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared. It will be de-identified prior to analysis.
Publications
Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
PubMed 17762378Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
PubMed 20559064Straub JM, New J, Hamilton CD, Lominska C, Shnayder Y, Thomas SM. Radiation-induced fibrosis: mechanisms and implications for therapy. J Cancer Res Clin Oncol. 2015 Nov;141(11):1985-94. doi: 10.1007/s00432-015-1974-6. Epub 2015 Apr 25.
PubMed 25910988Ridner SH, Dietrich MS, Sonis ST, Murphy B. Biomarkers Associated with Lymphedema and Fibrosis in Patients with Cancer of the Head and Neck. Lymphat Res Biol. 2018 Nov 28;16(6):516-24. doi: 10.1089/lrb.2017.0074. Online ahead of print.
PubMed 30484735Venkatesulu BP, Mahadevan LS, Aliru ML, Yang X, Bodd MH, Singh PK, Yusuf SW, Abe JI, Krishnan S. Radiation-Induced Endothelial Vascular Injury: A Review of Possible Mechanisms. JACC Basic Transl Sci. 2018 Aug 28;3(4):563-572. doi: 10.1016/j.jacbts.2018.01.014. eCollection 2018 Aug.
PubMed 30175280Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Lymphat Res Biol. 2016 Dec;14(4):198-205. doi: 10.1089/lrb.2016.0001. Epub 2016 Jun 15.
PubMed 27305456Elrefaey S, Massaro MA, Chiocca S, Chiesa F, Ansarin M. HPV in oropharyngeal cancer: the basics to know in clinical practice. Acta Otorhinolaryngol Ital. 2014 Oct;34(5):299-309.
PubMed 25709145Brayton KM, Hirsch AT, O Brien PJ, Cheville A, Karaca-Mandic P, Rockson SG. Lymphedema prevalence and treatment benefits in cancer: impact of a therapeutic intervention on health outcomes and costs. PLoS One. 2014 Dec 3;9(12):e114597. doi: 10.1371/journal.pone.0114597. eCollection 2014.
PubMed 25470383Brown M, McClean CM, Davison GW, Brown JCW, Murphy MH. The acute effects of walking exercise intensity on systemic cytokines and oxidative stress. Eur J Appl Physiol. 2018 Oct;118(10):2111-2120. doi: 10.1007/s00421-018-3930-z. Epub 2018 Jul 14.
PubMed 30008038Casuso RA, Aragon-Vela J, Huertas JR, Ruiz-Ariza A, Martinez-Lopez EJ. Comparison of the inflammatory and stress response between sprint interval swimming and running. Scand J Med Sci Sports. 2018 Apr;28(4):1371-1378. doi: 10.1111/sms.13046. Epub 2018 Jan 24.
PubMed 29281146Cullen T, Thomas AW, Webb R, Hughes MG. Interleukin-6 and associated cytokine responses to an acute bout of high-intensity interval exercise: the effect of exercise intensity and volume. Appl Physiol Nutr Metab. 2016 Aug;41(8):803-8. doi: 10.1139/apnm-2015-0640. Epub 2016 Mar 18.
PubMed 27377137Elmer DJ, Laird RH, Barberio MD, Pascoe DD. Inflammatory, lipid, and body composition responses to interval training or moderate aerobic training. Eur J Appl Physiol. 2016 Mar;116(3):601-9. doi: 10.1007/s00421-015-3308-4. Epub 2015 Dec 31.
PubMed 26721463Gmiat A, Micielska K, Kozlowska M, Flis DJ, Smaruj M, Kujach S, Jaworska J, Lipinska P, Ziemann E. The impact of a single bout of high intensity circuit training on myokines' concentrations and cognitive functions in women of different age. Physiol Behav. 2017 Oct 1;179:290-297. doi: 10.1016/j.physbeh.2017.07.004. Epub 2017 Jul 5.
PubMed 28687176Hoekstra SP, Bishop NC, Leicht CA. Can intervals enhance the inflammatory response and enjoyment in upper-body exercise? Eur J Appl Physiol. 2017 Jun;117(6):1155-1163. doi: 10.1007/s00421-017-3602-4. Epub 2017 Apr 4.
PubMed 28378071Hojman P, Brolin C, Norgaard-Christensen N, Dethlefsen C, Lauenborg B, Olsen CK, Abom MM, Krag T, Gehl J, Pedersen BK. IL-6 release from muscles during exercise is stimulated by lactate-dependent protease activity. Am J Physiol Endocrinol Metab. 2019 May 1;316(5):E940-E947. doi: 10.1152/ajpendo.00414.2018. Epub 2019 Feb 19.
PubMed 30779630
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT04679233
- Acronym / sponsor ID
- 201579
- Conditions
- Head and Neck Neoplasm, Radiotherapy
- Keywords
- Head and Neck Neoplasm, Radiotherapy, Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has withdrawn from the program, the study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Dec 2020 (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.
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).
Detailed description
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients, is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis.
Based on the evidence, the aerobic exercise prescription for those who provide informed consent will consist of 10 intervals of intensity, and 10 intervals at rest. Each interval of intensity will be 1 minutes long and each rest period will be 1 minute long, and there will be a five-minute warm-up and five-minute cool down of easy pedaling for a total of 30 minutes. Participants will complete two sessions per week, and there will be at least one business day in between each session, for a total of 10 total exercise sessions. The total study duration will be less than 35 days.
The supervised prescribed HIIE intervention will be performed on a stationary cycle ergometer. A cycle ergometer is preferred for safety reasons since it requires less gross motor coordination than might be required with a treadmill. To assist in establishing safety (primary aim), the study participants heart rate will be continually monitored by a clinician during the exercise, guiding them to keep their heart rate within their specifically calculated 80-95% of their maximum HR during the periods of intensity.
The investigators will compare outcomes at baseline with outcomes at the end of the 5-week study period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-test, post-test feasibility and safety study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention Arm | Experimental | Other: Prescription aerobic exerciseArm 1 will receive the aerobic prescription exercise intervention. As this is a feasibility and safety study, there will not be a second arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age
- Histologic proof of primary diagnosis of head and neck cancer
- Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months)
- Ability to understand English in order to understand instructions and complete questionnaires
- Willing to participate in the supervised exercise intervention
Key exclusion criteria (5 listed)
- Evidence of distant metastasis prior to enrollment
- Simultaneous primaries or unknown primary
- Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities
- An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions
- Pregnant or lactating women
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 |
|---|---|---|
| Prescription aerobic exercisehigh intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician. | Other | Arm 1: Intervention Arm |
Primary outcome
Qualitative Feasibility Log of Recruitment of Participants
Time frame: 6 months
To assess the feasibility of recruitment of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include qualitative information regarding noted barriers to recruitment and reasons for patients not participating
Quantified and Qualitative Log of Feasibility of Implementation
Time frame: 6 months
To investigate the feasibility of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include reasons that participants may have missed any of their assigned exercise sessions, as well as how many times they missed it.
Quantified and Qualitative Retention Log of Participants
Time frame: 6 months
To assess retention of a prescribed HIIE aerobic exercise modality for HNC patient. This will be measured by a Researchers Log which will include information such as number of participants enrolled, number of participants who dropped out, and reason for drop-out if available
Safety of the intervention as noted by parameters for serum bloodwork
Time frame: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log to ensure predetermined labs and electrolytes (platelets, magnesium, phosphorus, potassium) are within study parameter limits each week.
Safety of the intervention as noted by parameters for vitals signs prior to participation
Time frame: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include ensuring vitals signs (heart rate in beats per minute, blood pressure in mmHg, oxygen in saturation, respiration rate in rate per minutes, and temperature in celsius) are within study parameter limits
Safety of the intervention as noted by a timely log of adverse events,
Time frame: 6 months
To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include information such as measured by the CTCAE adverse events reported in accordance with and to the IRB
8 secondary outcomes
Feasibility of Collecting Bloodwork - Biomarker MMP-9
Time frame: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6
Time frame: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1β
Time frame: 6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-α
Time frame: 6 months
Feasibility of Collecting Bloodwork at two time points - TGF-β1
Time frame: 6 months
Feasibility of Collecting Patient Reported Outcome at two time points
Time frame: 6 months
Feasibility of Clinician Outcome at two time points
Time frame: 6 months
Qualitative data on Patient Experience
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Background: PubMed 17762378Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
- Background: PubMed 20559064Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
- Background: PubMed 25910988Straub JM, New J, Hamilton CD, Lominska C, Shnayder Y, Thomas SM. Radiation-induced fibrosis: mechanisms and implications for therapy. J Cancer Res Clin Oncol. 2015 Nov;141(11):1985-94. doi: 10.1007/s00432-015-1974-6. Epub 2015 Apr 25.
- Background: PubMed 30484735Ridner SH, Dietrich MS, Sonis ST, Murphy B. Biomarkers Associated with Lymphedema and Fibrosis in Patients with Cancer of the Head and Neck. Lymphat Res Biol. 2018 Nov 28;16(6):516-24. doi: 10.1089/lrb.2017.0074. Online ahead of print.
- Background: PubMed 30175280Venkatesulu BP, Mahadevan LS, Aliru ML, Yang X, Bodd MH, Singh PK, Yusuf SW, Abe JI, Krishnan S. Radiation-Induced Endothelial Vascular Injury: A Review of Possible Mechanisms. JACC Basic Transl Sci. 2018 Aug 28;3(4):563-572. doi: 10.1016/j.jacbts.2018.01.014. eCollection 2018 Aug.
- Background: PubMed 27305456Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Lymphat Res Biol. 2016 Dec;14(4):198-205. doi: 10.1089/lrb.2016.0001. Epub 2016 Jun 15.
- Background: PubMed 25709145Elrefaey S, Massaro MA, Chiocca S, Chiesa F, Ansarin M. HPV in oropharyngeal cancer: the basics to know in clinical practice. Acta Otorhinolaryngol Ital. 2014 Oct;34(5):299-309.
- Background: PubMed 25470383Brayton KM, Hirsch AT, O Brien PJ, Cheville A, Karaca-Mandic P, Rockson SG. Lymphedema prevalence and treatment benefits in cancer: impact of a therapeutic intervention on health outcomes and costs. PLoS One. 2014 Dec 3;9(12):e114597. doi: 10.1371/journal.pone.0114597. eCollection 2014.
- Background: PubMed 30008038Brown M, McClean CM, Davison GW, Brown JCW, Murphy MH. The acute effects of walking exercise intensity on systemic cytokines and oxidative stress. Eur J Appl Physiol. 2018 Oct;118(10):2111-2120. doi: 10.1007/s00421-018-3930-z. Epub 2018 Jul 14.
- Background: PubMed 29281146Casuso RA, Aragon-Vela J, Huertas JR, Ruiz-Ariza A, Martinez-Lopez EJ. Comparison of the inflammatory and stress response between sprint interval swimming and running. Scand J Med Sci Sports. 2018 Apr;28(4):1371-1378. doi: 10.1111/sms.13046. Epub 2018 Jan 24.
- Background: PubMed 27377137Cullen T, Thomas AW, Webb R, Hughes MG. Interleukin-6 and associated cytokine responses to an acute bout of high-intensity interval exercise: the effect of exercise intensity and volume. Appl Physiol Nutr Metab. 2016 Aug;41(8):803-8. doi: 10.1139/apnm-2015-0640. Epub 2016 Mar 18.
- Background: PubMed 26721463Elmer DJ, Laird RH, Barberio MD, Pascoe DD. Inflammatory, lipid, and body composition responses to interval training or moderate aerobic training. Eur J Appl Physiol. 2016 Mar;116(3):601-9. doi: 10.1007/s00421-015-3308-4. Epub 2015 Dec 31.
- Individual participant dataSharing planned: No. individual participant data will not be shared. It will be de-identified prior to analysis.
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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. This study is not recruiting at the moment.
Bethany Rhoten, PhD study chair
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription aerobic exercise in people with Head and Neck Neoplasm and Radiotherapy, run by Vanderbilt University at 1 site in United States.
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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Feasibility Log of Recruitment of Participants (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679233, which also lists 59 linked publications.
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 24 Feb 2022.