Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Strength Training, Exercise, Quality of Life, Randomized Controlled Trial
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.
Interventions
OTHERExperimental
Three 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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Participants and investigators will not be blinded to group assignment given the nature of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Followup assessment rate | Postintervention (12 weeks) | Followup assessment 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
| Measure | Time frame | Description |
|---|---|---|
| Muscular 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 strength |
| 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 life |
| Fear 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 recurrence |
| Symptom Burden | Baseline and Postintervention (12 weeks) | Assessed via the revised Edmonton Symptom Assessment System Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms |
| Perceived Stress | Baseline and Postintervention (12 weeks) | Assessed via the Perceived Stress Scale Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress |
| Self-Esteem | Baseline and Postintervention (12 weeks) | Assessed via the Rosenberg Self-Esteem Scale Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteem |
| Sleep Habits | Baseline and Postintervention (12 weeks) | Assessed via the Insomnia Severity Index Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia |
| Malnutrition 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 options |
| Swallowing Abilities | Baseline and Postintervention (12 weeks) | Assessed via the MD Anderson Dysphagia Inventory Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing ability |
| Shoulder 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 mobility |
| Body 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=worse |
| Handgrip Strength | Baseline and Postintervention (12 weeks) | Assessed via held held dynamometer Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength |
| Physical Function | Baseline and Postintervention (12 weeks) | Assessed via the six minute walk test Minimum: 0 metres, Maximum: none. Higher score=better physical function |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORKerry Courneya
University of Alberta
Outcome results
None listed