Clinical trial NCT01794481: Benefits of Exercise Training in Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
Official title: Benefits of Resistance Exercise Training in Locally Advanced Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.
timeFrame: 14 weeks
Secondary outcomes:
measure: The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of muscle strength.
timeFrame: 14 weeks
measure: The effect of resistance exercise training (RET) versus usual care (UC) on six minute walk distance
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Veterans Affairs (VA) Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Shruti Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References: