Benefits of Exercise Training in Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy

NCT ID: NCT01794481

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is to evaluate the potential benefit of an individualized resistance exercise-training program during radiotherapy for patients with locally advanced head and neck cancer.

Detailed Description

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants 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 Type: NO_INTERVENTION

No interventions assigned to this group

Resistance Exercise Training

If 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.

Group Type: EXPERIMENTAL

Resistance Exercise Training (RET)

Intervention Type: PROCEDURE

If 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.

Interventions

Resistance Exercise Training (RET)

If 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• Patients must be willing to comply with the study procedures and visits

Exclusion Criteria

• Active cardiopulmonary disease
• Substantial dementia (based on Folstein Mini Mental State Examination <24 out of 30)
• 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 refusing a percutaneous endoscopic gastrotomy (PEG) Tube needed for nutrition, as determined necessary by treating physician
• Patients are actively being treated for another cancer at the time of enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shruti Jolly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

Veterans Affairs (VA) Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM 33897

Identifier Type: OTHER

Identifier Source: secondary_id

2011.070

Identifier Type: -

Identifier Source: org_study_id