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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794481
• Other study ID #: 2011.070
• Secondary ID: HUM 33897
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: May 18, 2015
• Start date: January 2010
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs (VA) Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.	Lean body mass will be analyzed at baseline, 3, 5, and 7-weeks (representing the last week of cancer treatment and end of on-site RET), 11-weeks (first clinic follow-up) and 14-weeks (second clinic follow-up and end of home-based RET program) for patients on both arms of the study.	14 weeks	No
Secondary	The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of muscle strength.	Upper and lower body strength will be analyzed at baseline, 3, 5, and 7-weeks (representing the last week of cancer treatment and end of on-site RET), 11-weeks (first clinic follow-up) and 14-weeks (second clinic follow-up and end of home-based RET program) for patients on both arms of the study.	14 weeks	No
Secondary	The effect of resistance exercise training (RET) versus usual care (UC) on six minute walk distance	The distance walked in six minutes at baseline will be compared to the distance walked at 14 weeks for both groups. These finding will then be compared between the groups.	14 weeks	No