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

February 7, 2022 updated by: Vanderbilt University

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
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
6 months
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.
6 months
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
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Collecting Bloodwork - Biomarker MMP-9
Time Frame: 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.
6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6
Time Frame: 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.
6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1β
Time Frame: 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.
6 months
Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-α
Time Frame: 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.
6 months
Feasibility of Collecting Bloodwork at two time points - TGF-β1
Time Frame: 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 months
Feasibility of Collecting Patient Reported Outcome at two time points
Time Frame: 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.
6 months
Feasibility of Clinician Outcome at two time points
Time Frame: 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"
6 months
Qualitative data on Patient Experience
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Johns Hopkins University

Investigators

  • Study Chair: Bethany Rhoten, PhD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (ACTUAL)

December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data will not be shared. It will be de-identified prior to analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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