Heavy Strength Training in Head and Neck Cancer Survivors

Head and Neck Cancer Clinical Trial

— LIFTING2  

Official title:

Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289049
• Other study ID #: HREBA.CC-24-0021
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Stephanie Ntoukas
• Phone: 7804922829
• Email: ntoukas[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Cancer
• Head and Neck Carcinoma
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Experimental
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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Recruitment range: 40 to 60 participants; Higher=better and more available data	Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Primary	Adherence to a heavy lifting strength training program	Adherence rate: 0 to 100 percent of exercise sessions; Higher=better	Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Primary	Completion of maximal strength testing	3 repetition maximum testing rate: 0 to 100 percent; Higher=better	Baseline and postintervention (12 weeks)
Primary	Followup assessment rate	Followup assessment rate: 0 to 100 percent; Higher=better	Postintervention (12 weeks)
Primary	Safety	Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse	Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Secondary	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	Baseline and Postintervention (12 weeks)
Secondary	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	Baseline and Postintervention (12 weeks)
Secondary	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	Baseline and Postintervention (12 weeks)
Secondary	Symptom Burden	Assessed via the revised Edmonton Symptom Assessment System; Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms	Baseline and Postintervention (12 weeks)
Secondary	Perceived Stress	Assessed via the Perceived Stress Scale; Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress	Baseline and Postintervention (12 weeks)
Secondary	Self-Esteem	Assessed via the Rosenberg Self-Esteem Scale; Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteem	Baseline and Postintervention (12 weeks)
Secondary	Sleep Habits	Assessed via the Insomnia Severity Index; Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia	Baseline and Postintervention (12 weeks)
Secondary	Malnutrition Status	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	Baseline and Postintervention (12 weeks)
Secondary	Swallowing Abilities	Assessed via the MD Anderson Dysphagia Inventory; Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing ability	Baseline and Postintervention (12 weeks)
Secondary	Shoulder Range of Motion	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	Baseline and Postintervention (12 weeks)
Secondary	Body composition	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	Baseline and Postintervention (12 weeks)
Secondary	Handgrip Strength	Assessed via held held dynamometer; Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength	Baseline and Postintervention (12 weeks)
Secondary	Physical Function	Assessed via the six minute walk test; Minimum: 0 metres, Maximum: none. Higher score=better physical function	Baseline and Postintervention (12 weeks)