Heavy Strength Training in Head and Neck Cancer Survivors (LIFTING2)

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma
• Intervention / Treatment: Other: Experimental

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Stephanie Ntoukas; Phone Number: 7804922829; Email: ntoukas@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta
      • Contact: Stephanie Ntoukas; Email: ntoukas@ualberta.ca
      • Principal Investigator: Kerry Courneya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; 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.	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.; Other Names: Exercise Group
No Intervention: Usual Care Group; Participants randomized to the usual care group will be asked to continue will their typical daily routine during the 12 week study period, and not begin any new exercise program to increase their exercise levels from baseline. They will not receive any information or education regarding exercise. After the postintervention assessments, participants in the usual care group will be offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Completion of maximal strength testing	3 repetition maximum testing rate: 0 to 100 percent; Higher=better	Baseline and postintervention (12 weeks)
Followup assessment rate	Followup assessment rate: 0 to 100 percent; Higher=better	Postintervention (12 weeks)
Safety	Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse	Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Perceived Stress	Assessed via the Perceived Stress Scale Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress	Baseline and Postintervention (12 weeks)
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)
Sleep Habits	Assessed via the Insomnia Severity Index Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia	Baseline and Postintervention (12 weeks)
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)
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)
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)
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)
Handgrip Strength	Assessed via held held dynamometer Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength	Baseline and Postintervention (12 weeks)
Physical Function	Assessed via the six minute walk test Minimum: 0 metres, Maximum: none. Higher score=better physical function	Baseline and Postintervention (12 weeks)

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Kerry Courneya, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Randomized Controlled Trial; Strength Training
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Behavior; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Motor Activity
• Other Study ID Numbers: HREBA.CC-24-0021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No