About this trial
Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
males and females, 18 years of age and older
any head and neck cancer subtype, stage, and treatment type
at least 1-year posttreatment with adequate shoulder range of motion (must meet minimum cutpoints for active flexion and abduction to be eligible)
no unmanaged medical conditions, alcohol, or drug abuse
Disqualifiers
has met the Canadian Physical Activity strength training guidelines within the past one-month: at least two days per week of muscle and bone strength training activities using major muscle groups
currently involved in a different exercise trial or clinical drug trial
Trial design
Parallel
Treatments tested in this trial
Experimental
Other interventionThree primary exercises will be included in the exercise sessions for participants randomized to this group: barbell back squat, bench press, and dead lift The weight will be progressively increased overtime based on participants' perceived exertion and repetitions in reserve. Number of repetitions performed for each exercise will begin at 10 repetitions in weeks 1-2, with gradual progression to lifting heavier loads of 3-5 sets of 1-5 repetitions between weeks 6-12.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
Recruitment range: 40 to 60 participants; Higher=better and more available data
Adherence to a heavy lifting strength training program
Adherence rate: 0 to 100 percent of exercise sessions; Higher=better
Completion of maximal strength testing
3 repetition maximum testing rate: 0 to 100 percent; Higher=better
Followup assessment rate
Followup assessment rate: 0 to 100 percent; Higher=better
Secondary outcomes
Muscular Strength
Assessed via 3 repetition maximum tests on the chest press and leg press machines Minimum: 0 kilograms, Maximum: none. Higher score=better strength
Cancer Specific Quality of Life
Assessed via cancer specific European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Minimum: 0 points, Maximum: 100 points. Higher score=better quality of life
Fear of Cancer Recurrence
Assessed via the Fear of Cancer Recurrence Inventory - Short Form Minimum: 0 points, Maximum: 36 points. Higher score=worse fear of cancer recurrence
Symptom Burden
Assessed via the revised Edmonton Symptom Assessment System Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms
Sponsors and contacts
Click on the lead sponsor to view all of their trials.