Clinical trial NCT01332682: Resistance Training and Physical Functioning in Head and Neck Cancer Patients
Official title: Resistance Training and Physical Functioning in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Pharyngeal Cancer
Laryngeal Cancer
Keywords: head and neck cancer
resistance training
nutrition counseling
pharyngeal or laryngeal cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this feasibility study is to examine the safety and effect of resistance training on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head and neck cancer patients receiving radiation therapy.

Detailed description: Head and neck cancer (HNCa) patients often lose significant body weight and lean mass which is associated with higher mortality, greater fatigue, poorer quality of life, and reduced physical functioning. Because nutritional supplementation may not consistently improve lean body mass, resistance training may be beneficial. HNCa patients experience unique side effects that impact nutritional status, limiting generalization of exercise intervention study results in other cancer types to HNCa patients. Therefore, 44 HNCa patients will be enrolled in a randomized controlled trial with the following study aims:

Primary study aim: Because this pilot proposal is among the first to attempt a randomized controlled exercise trial in HNCa patients, the primary study aim examines safety and feasibility (e.g., study acceptance, recruitment, intervention process evaluation, adherence, adverse events, retention). The investigators hypothesize that study procedures will require minor alterations in future studies.

Secondary study aim #1: Because effect sizes are necessary for planning efficacy trials, the proposal will compare the effect of a 12-week resistance training plus nutritional counseling intervention versus nutritional counseling alone on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in HNCa patients receiving radiation with or without chemotherapy. The investigators hypothesize that patients receiving resistance training with nutritional counseling will demonstrate greater improvements in the outcomes when compared with participants receiving nutritional counseling alone.

Secondary study aim #2: To enhance adherence in future intervention trials, this proposal will determine resistance training and nutritional adherence rates and associated factors among HNCa patients using attendance records, exercise logs, diet records, self-administered survey, and medical record review. The investigators hypothesize that adherence rates will be lower than that of other cancer populations with correlates including demographic, medical, and psychosocial factors.

Assessments will occur at baseline (first week of radiation), week 6 (mid-intervention), and week 12 (post-intervention). Qualitative and quantitative (e.g., rates, 95% confidence intervals) will assess feasibility and mixed model ANOVA will examine group differences. This information is critical for the design of future resistance training efficacy trials in HNCa patients to prevent lean body mass loss in HNCa patients, potentially reducing mortality, minimizing fatigue, and improving physical functioning and quality of life.

Eligibility criteria: Inclusion criteria:

* cancer of the oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland
* ≥ 18 years of age
* English speaking
* radiation therapy planned or underway \< 1 week, and
* able to stand

Exclusion Criteria:

* dementia or organic brain syndrome
* severe emotional distress
* active schizophrenia
* quadriplegia or loss of use of limbs or torso
* tendon rupture
* muscle tear
* cancer recurrence
* another diagnoses of cancer in the past 5 years, and
* oncologist refuses to allow screening for possible study participation

Primary outcomes:
measure: safety of head and neck cancer patients
timeFrame: daily (up to 12 weeks)
Secondary outcomes:
measure: change in muscle strength
timeFrame: baseline, week 6, and week 12
measure: Number of patients who adhere to cohort activity schedule
timeFrame: baseline, week 6, and week 12
measure: change in lean body mass
timeFrame: baseline, week 6, week 12
measure: change in physical functioning
timeFrame: baseline, week 6, week 12
measure: change in fatigue level
timeFrame: baseline, week 6, week 12
measure: change in quality of life
timeFrame: baseline, week 6, week 12
measure: Number of head and neck cancer patients recruited to participate
timeFrame: up to 16 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Laura Q Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.
citation: Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.
citation: Rogers LQ, Anton PM, Fogleman A, Hopkins-Price P, Verhulst S, Rao K, Malone J, Robbs R, Courneya KS, Nanavati P, Mansfield S, Robbins KT. Pilot, randomized trial of resistance exercise during radiation therapy for head and neck cancer. Head Neck. 2013 Aug;35(8):1178-88. doi: 10.1002/hed.23118. Epub 2012 Jul 30.