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


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Squamous Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.

Outcome Description:

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.

Outcome Time Frame:

14 weeks

Safety Issue:

No

Principal Investigator

Shruti Jolly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011.070

NCT ID:

NCT01794481

Start Date:

January 2010

Completion Date:

January 2016

Related Keywords:

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

Name

Location
The University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109