Heavy Strength Training in Head and Neck Cancer Survivors
- Conditions
- Head and Neck Squamous Cell CarcinomaHead and Neck CarcinomaHead and Neck NeoplasmsHead and Neck Cancer
- Interventions
- Other: Experimental
- Registration Number
- NCT06289049
- Lead Sponsor
- University of Alberta
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Group Experimental The exercise intervention will consist of 24 supervised, heavy lifting strength training exercise sessions over a 12 week period. The exercise frequency will be two times per week. Main exercises will consist of barbell back squat, bench press, and dead lift.
- Primary Outcome Measures
Name Time Method Followup assessment rate Postintervention (12 weeks) Followup assessment rate: 0 to 100 percent; Higher=better
Recruitment rate Baseline, postintervention (12 weeks), and monitored throughout 12 week study period Recruitment range: 40 to 60 participants; Higher=better and more available data
Adherence to a heavy lifting strength training program Baseline, postintervention (12 weeks), and monitored throughout 12 week study period Adherence rate: 0 to 100 percent of exercise sessions; Higher=better
Completion of maximal strength testing Baseline and postintervention (12 weeks) 3 repetition maximum testing rate: 0 to 100 percent; Higher=better
Safety Baseline, postintervention (12 weeks), and monitored throughout 12 week study period Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse
- Secondary Outcome Measures
Name Time Method Cancer Specific Quality of Life Baseline and Postintervention (12 weeks) 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 lifeSymptom Burden Baseline and Postintervention (12 weeks) Assessed via the revised Edmonton Symptom Assessment System
Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptomsMuscular Strength Baseline and Postintervention (12 weeks) Assessed via 3 repetition maximum tests on the chest press and leg press machines
Minimum: 0 kilograms, Maximum: none. Higher score=better strengthFear of Cancer Recurrence Baseline and Postintervention (12 weeks) Assessed via the Fear of Cancer Recurrence Inventory - Short Form
Minimum: 0 points, Maximum: 36 points. Higher score=worse fear of cancer recurrencePerceived Stress Baseline and Postintervention (12 weeks) Assessed via the Perceived Stress Scale
Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stressSelf-Esteem Baseline and Postintervention (12 weeks) Assessed via the Rosenberg Self-Esteem Scale
Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteemSleep Habits Baseline and Postintervention (12 weeks) Assessed via the Insomnia Severity Index
Minimum: 0 points, Maximum: 28 points. Higher score=worse insomniaMalnutrition Status Baseline and Postintervention (12 weeks) Assessed via the Patient Generated Subjective Global Assessment with reference to the Global Leadership Initiative on Malnutrition
Minimum: 0 points, Maximum: 36 points. Higher score=worse, high risk of malnutrition
0-1 points: no intervention required at this time. Re-assessment on routine and regular basis during treatment.
2-3 points: patient \& family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate
4-8 points: requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms
≥ 9 points: indicates a critical need for improved symptom management and/or nutrient intervention optionsHandgrip Strength Baseline and Postintervention (12 weeks) Assessed via held held dynamometer
Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strengthSwallowing Abilities Baseline and Postintervention (12 weeks) Assessed via the MD Anderson Dysphagia Inventory
Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing abilityShoulder Range of Motion Baseline and Postintervention (12 weeks) Assessed via seated active flexion and abduction using a goniometer
Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years), Maximum: none Higher score=better shoulder mobilityBody composition Baseline and Postintervention (12 weeks) Assessed via bioelectrical impedance analysis (InBody 770)
Minimum: none, Maximum: none. Higher score=variable Higher fat free mass score=better Higher fat mass score=worsePhysical Function Baseline and Postintervention (12 weeks) Assessed via the six minute walk test
Minimum: 0 metres, Maximum: none. Higher score=better physical function
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada