Completed
Benefits of Resistance Exercise Training in Locally Advanced Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
What is being tested
Resistance Exercise Training (RET)
Procedure
Who is being recruted
Carcinoma+5
+ Carcinoma, Squamous Cell
+ Head and Neck Neoplasms
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: January 2010
Summary
Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: May 20, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2010
Actual date on which the first participant was enrolled.Patients with locally advanced head and neck cancer are treated with radiation therapy (with/without chemotherapy) to avoid large surgical procedures. However, definitive radiation treatments can cause side effects (like mouth sores, difficulty swallowing) that often cause weight loss. It has been shown that a significant percentage of the weight loss is due to loss of muscle mass. Resistance exercise training works to increase muscle strength and endurance by doing repetitive exercises with weights, weight machines, or resistance bands.
Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: May 20, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSquamous Cell Carcinoma of Head and Neck
Criteria
2 inclusion criteria required to participate
Patients must be willing to comply with the study procedures and visits
Patients with American Joint Committee on Cancer (AJCC) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with radiotherapy (with or without chemotherapy or targeted agents), and who are capable of understanding and adhering to the protocol requirements
6 exclusion criteria prevent from participating
Active cardiopulmonary disease
Acute medical conditions, such as acute flare-up of joint condition or infection
Participants must not be actively receiving physical therapy, at time of enrollment, or actively exercising 2 or more hours a day, with the intent to continue that regimen
Patients are actively being treated for another cancer at the time of enrollment
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionParticipants allocated to usual care will receive their usual treatment program which will include dietician counseling as needed.
As part of standardized care, participants will not be encouraged to begin a new exercise program(patients needing physical therapy at time of enrollment will be excluded.
Group II
ExperimentalIf you are randomized to the resistance exercise training (RET) program, you will undergo up to three 1-hour training sessions per week for 7 weeks during radiation therapy.
There will be up to 3 sessions per week lasting up to one hour, and will generally include a 10- minute warm-up, rest periods and 10 minute cool-down. The goal is to perform the exercises as tolerated in week 1 and increase intensity as the weeks progress. Weights will be added each week depending on your tolerance to them. Rest periods will be incorporated into the exercises as needed. The intensity and weights used will be customized to the individual. During the home program portion, you will be asked to keep a weekly log of your exercises and the trainer will call you weekly to go over the log and provide support. At week 11 the trainer will meet with you to go over your individualized program and review your technique.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Veterans Affairs (VA) Ann Arbor Healthcare System
Ann Arbor, United StatesOpen Veterans Affairs (VA) Ann Arbor Healthcare System in Google MapsThe University of Michigan Comprehensive Cancer Center
Ann Arbor, United StatesCompleted2 Study Centers