Head and Neck NeoplasmsPhase 2LIFTING2NCT06289049
Heavy Strength Training in Head and Neck Cancer Survivors
A Phase 2 study testing Experimental in people with Head and Neck Neoplasms and Head and Neck Cancer, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 17 Feb 2025to 6 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma
- Being tested
- Experimental
- Keywords
- Strength Training, Exercise, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Exercise Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 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. Receives: Other: Experimental |
| Usual Care Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment range: 40 to 60 participants; Higher=better and more available data
Measured: 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
Measured: 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
Measured: Baseline and postintervention (12 weeks)
Followup assessment rate
Followup assessment rate: 0 to 100 percent; Higher=better
Measured: Postintervention (12 weeks)
Safety
Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse
Measured: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and Postintervention (12 weeks)
Perceived Stress
Assessed via the Perceived Stress Scale
Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress
Measured: 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
Measured: Baseline and Postintervention (12 weeks)
Sleep Habits
Assessed via the Insomnia Severity Index
Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and Postintervention (12 weeks)
Handgrip Strength
Assessed via held held dynamometer
Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength
Measured: Baseline and Postintervention (12 weeks)
Physical Function
Assessed via the six minute walk test
Minimum: 0 metres, Maximum: none. Higher score=better physical function
Measured: Baseline and Postintervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start17 Feb 2025
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry Courneya, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289049
- Sponsor's protocol ID
- HREBA.CC-24-0021
- Acronym
- LIFTING2
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06289049
- Acronym / sponsor ID
- LIFTING2 / HREBA.CC-24-0021
- Conditions
- Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma
- Keywords
- Strength Training, Exercise, Quality of Life, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExperimentalThe 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. |
| Usual Care Group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Exercise GroupThree 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 | Exercise Group |
Primary outcome
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
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
Completion of maximal strength testing
Time frame: Baseline and postintervention (12 weeks)
3 repetition maximum testing rate: 0 to 100 percent; Higher=better
Followup assessment rate
Time frame: Postintervention (12 weeks)
Followup assessment rate: 0 to 100 percent; Higher=better
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
13 secondary outcomes
Muscular Strength
Time frame: Baseline and Postintervention (12 weeks)
Cancer Specific Quality of Life
Time frame: Baseline and Postintervention (12 weeks)
Fear of Cancer Recurrence
Time frame: Baseline and Postintervention (12 weeks)
Symptom Burden
Time frame: Baseline and Postintervention (12 weeks)
Perceived Stress
Time frame: Baseline and Postintervention (12 weeks)
Self-Esteem
Time frame: Baseline and Postintervention (12 weeks)
Sleep Habits
Time frame: Baseline and Postintervention (12 weeks)
Malnutrition Status
Time frame: Baseline and Postintervention (12 weeks)
Swallowing Abilities
Time frame: Baseline and Postintervention (12 weeks)
Shoulder Range of Motion
Time frame: Baseline and Postintervention (12 weeks)
Body composition
Time frame: Baseline and Postintervention (12 weeks)
Handgrip Strength
Time frame: Baseline and Postintervention (12 weeks)
Physical Function
Time frame: Baseline and Postintervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry Courneya principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental in people with Head and Neck Neoplasms and Head and Neck Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.