Clincosm LogoSign in Get a demo

Feasibility and Safety of Aerobic Exercise for Head and Neck Cancer Patients

Sponsor
Vanderbilt University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04679233
Collaborator
Johns Hopkins University (Other)
0
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Prescription aerobic exercise
 N/A

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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group pre-test, post-test feasibility and safety studySingle group pre-test, post-test feasibility and safety study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Intervention Arm

Arm 1 will receive the aerobic prescription exercise intervention. As this is a feasibility and safety study, there will not be a second arm.

Other: Prescription aerobic exercise
high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.

Outcome Measures

Primary Outcome Measures

  1. Qualitative Feasibility Log of Recruitment of Participants [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

  2. Quantified and Qualitative Log of Feasibility of Implementation [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.

  3. Quantified and Qualitative Retention Log of Participants [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

  4. Safety of the intervention as noted by parameters for serum bloodwork [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.

  5. Safety of the intervention as noted by parameters for vitals signs prior to participation [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

  6. Safety of the intervention as noted by a timely log of adverse events, [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

Secondary Outcome Measures

  1. Feasibility of Collecting Bloodwork - Biomarker MMP-9 [6 months]

    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.

  2. Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6 [6 months]

    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.

  3. Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1β [6 months]

    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.

  4. Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-α [6 months]

    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.

  5. Feasibility of Collecting Bloodwork at two time points - TGF-β1 [6 months]

    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.

  6. Feasibility of Collecting Patient Reported Outcome at two time points [6 months]

    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.

  7. Feasibility of Clinician Outcome at two time points [6 months]

    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"

  8. Qualitative data on Patient Experience [6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Baltimore Maryland United States 21231

Sponsors and Collaborators

  • Vanderbilt University
  • Johns Hopkins University

Investigators

  • Study Chair: Bethany Rhoten, PhD, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT04679233
Other Study ID Numbers:
  • 201579
First Posted:
Dec 22, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanderbilt University
Head and Neck Neoplasm
Radiotherapy
Exercise
Additional relevant MeSH terms:
Head and Neck Neoplasms

Study Results

No Results Posted as of Feb 24, 2022