Heavy Strength Training in Head and Neck Cancer Survivors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Exercise GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

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

Time frame
Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
2

Adherence to a heavy lifting strength training program

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

Time frame
Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
3

Completion of maximal strength testing

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

Time frame
Baseline and postintervention (12 weeks)
4

Followup assessment rate

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

Time frame
Postintervention (12 weeks)

Secondary outcomes

1

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

Time frame
Baseline and Postintervention (12 weeks)
2

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

Time frame
Baseline and Postintervention (12 weeks)
3

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

Time frame
Baseline and Postintervention (12 weeks)
4

Symptom Burden

Assessed via the revised Edmonton Symptom Assessment System Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms

Time frame
Baseline and Postintervention (12 weeks)

Other outcomes

Sponsors and contacts

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