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

NCT04679233 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-02-24

No results posted yet for this study

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).

Conditions

  • Head and Neck Neoplasm
  • Radiotherapy

Interventions

OTHER

Prescription aerobic exercise

high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.

Sponsors & Collaborators

Principal Investigators

  • Bethany Rhoten, PhD · Vanderbilt University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679233 on ClinicalTrials.gov