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NCT Number: NCT06289049

Heavy Strength Training in Head and Neck Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta

Edmonton, Alberta, Canada

Location status: Recruiting

Location contact

Kerry Courneya

PRINCIPAL_INVESTIGATOR

Stephanie Ntoukas

CONTACT

[email protected]

About this study

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Other

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

Primary outcomes

  1. Recruitment rate

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

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

  2. Adherence to a heavy lifting strength training program

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

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

  3. Completion of maximal strength testing

    Time frame: Baseline and postintervention (12 weeks)

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

  4. Followup assessment rate

    Time frame: Postintervention (12 weeks)

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

  5. Safety

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

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

Secondary outcomes

  1. Muscular Strength

    Time frame: 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

  2. Cancer Specific Quality of Life

    Time frame: 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

  3. Fear of Cancer Recurrence

    Time frame: 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

  4. Symptom Burden

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the revised Edmonton Symptom Assessment System

    Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms

  5. Perceived Stress

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the Perceived Stress Scale

    Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress

  6. Self-Esteem

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the Rosenberg Self-Esteem Scale

    Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteem

  7. Sleep Habits

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the Insomnia Severity Index

    Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia

  8. Malnutrition Status

    Time frame: 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

  9. Swallowing Abilities

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the MD Anderson Dysphagia Inventory

    Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing ability

  10. Shoulder Range of Motion

    Time frame: 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

  11. Body composition

    Time frame: 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

  12. Handgrip Strength

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via held held dynamometer

    Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength

  13. Physical Function

    Time frame: Baseline and Postintervention (12 weeks)

    Assessed via the six minute walk test

    Minimum: 0 metres, Maximum: none. Higher score=better physical function

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Ntoukas

CONTACT

[email protected]

7804922829

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: LIFTING2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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