Heavy Strength Training in Head and Neck Cancer Survivors

Phase 2RecruitingNCT06289049

University of Alberta60 enrolled

Overview

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.

1. Background and Rationale 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. 2. Research Question \& Objectives The primary aim of the proposed study is to further establish the feasibility of HLST in HNCS which will be based on the eligibility rate, recruitment rate, one-repetition max (3RM) testing rate, HLST program adherence, and follow-up assessment rate. A secondary aim is to provide preliminary evidence of the effects of a HLST program compared to usual care (UC) in HNCS. The primary efficacy outcome will be upper and lower muscular strength assessed by reliable 3-repetition maximum (3RM) tests on the chest press and leg press machines. Secondary efficacy outcomes include physical function, handgrip strength, body composition, QoL, fear of cancer recurrence, symptom burden, pain, anxiety, fatigue, stress, self-esteem, shoulder mobility, sleep, malnutrition status, and swallowing abilities. 3. Methods This single-centre, two-armed, randomized controlled trial will recruit 60 HNCS ≥1-year posttreatment, and randomly assign them to the HLST group or UC group. For the HLST group, the 12-week exercise intervention will include supervised training 2 days per week. The HLST group will progress to lifting low repetitions of heavy loads at 80-90% of one repetition maximum (1RM), whereas the UC group will not receive any exercise prescription or instruction during the 12-week intervention, but will be offered a 4-week introduction to HLST program and/or referred to a community-based program after the postintervention assessments are complete. Assessments for both groups will occur at baseline and postintervention and include reliable 3RM strength tests, bioelectrical impedance analysis (BIA), Senior's Fitness Test, and validated QoL questionnaires.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * approved for exercise by oncologist and a certified exercise physiologist or kinesiologist * ability to understand and communicate in English Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Recruitment rate

Recruitment range: 40 to 60 participants; Higher=better and more available data

Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

Adherence to a heavy lifting strength training program

Adherence rate: 0 to 100 percent of exercise sessions; Higher=better

Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

Completion of maximal strength testing

3 repetition maximum testing rate: 0 to 100 percent; Higher=better

Time frame: Baseline and postintervention (12 weeks)

Followup assessment rate

Followup assessment rate: 0 to 100 percent; Higher=better

Time frame: Postintervention (12 weeks)

Safety

Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse

Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

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