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Cancer of Head and NeckPhase 1LIFTINGNCT04554667

Heavy Lifting Strength Training in Head and Neck Cancer Survivors

A Phase 1 study testing Exercise Intervention in people with Cancer of Head and Neck, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Head and Neck
What is being tested?
Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteCanada
Study dates
24 Nov 2020to 31 Jul 2022
Phase
Phase 1
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

  • previously diagnosed with any subtype and stage of head and neck cancer
  • at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
  • adults ages 18 and older
  • no unmanaged medical conditions, alcohol, and drug abuse
  • approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
  • ability to understand and communicate in English

Who cannot join

  • having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2H9

Other trials in Canada

About this study

Official title: Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection

The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

Read the detailed description

RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.

OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.

METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.

SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.

Keywords
surgery, neck dissection, strength training, survivors, exercise
Medical subject headings
Head and Neck Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04554667
Study groupRoleWhat they receive
Exercise InterventionExperimentalSingle exercise arm
Receives: Behavioral: Exercise Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Recruitment rate (with reasons for refusal).

    Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data

    Measured: Over 12 weeks

  2. Muscular Strength

    Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests.

    Minimum: none Maximum: none Higher score= better strength

    Measured: Changes from baseline to 12 weeks

  3. Program Adherence

    Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence

    Measured: Over 12 weeks

Secondary outcomes (15)

  1. Physical functioning

    Assessed using the Neck Dissection Impairment Index (NDII) and maximum strength tests.

    Minimum: 40 Maximum: 100 Higher score= worse impairment

    Measured: Changes from baseline to 12 weeks

  2. Fear of cancer recurrence

    Assessed using the Fear of Cancer Recurrence Inventory (FCRI)

    Minimum: 0 Maximum: 36 Higher score= worse fear of cancer recurrence

    Measured: Changes from baseline to 12 weeks

  3. Post Traumatic Growth after cancer

    How cancer has changed an individual's life will be assessed using the Post Traumatic Growth Inventory (PTGI)

    Minimum: 0 Maximum: 105 Higher score= better (positive) post traumatic growth transformation

    Measured: Changes from baseline to 12 weeks

  4. Waist to hip ratio (body composition)

    Assessed using waist to hip ratio (WHR) measure.

    Minimum WHR: none Maximum WHR: none Higher score WHR= worse body composition

    Measured: Changes from baseline to 12 weeks

  5. Anxiety

    Assessed using the Spielberger State Trait Anxiety Inventory (STAI)

    Minimum: 20 Maximum: 80 Higher score= worse anxiety

    Measured: Changes from baseline to 12 weeks

  6. Fatigue

    Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire

    Minimum: 0 Maximum: 52 Higher score=worse fatigue

    Measured: Changes from baseline to 12 weeks

  7. Stress

    Assessed using the Perceived Stress Scale (PSS)

    Minimum: 0 Maximum: 56 Higher score=worse perceived stress

    Measured: Changes from baseline to 12 weeks

  8. Shoulder Mobility

    Changes in shoulder mobility

    Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years) Maximum: none Higher score= better mobility

    Measured: Changes from baseline to 12 weeks

  9. Self-Esteem

    Changes in level of self-esteem assessed using Rosenberg Self-Esteem (RSE) scale

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

    Measured: Changes from baseline to 12 weeks

  10. Sleep

    Changes in sleep patterns assessed using the insomnia severity index (ISI)

    Minimum: 0 Maximum: 28 Higher score= worse insomnia

    Measured: Changes from baseline to 12 weeks

  11. Motivation

    Questions based on the theory of planned behaviour

    Minimum: 7 Maximum: 35 Higher score= better motivation

    Measured: Changes from baseline to 12 weeks

  12. Cancer specific quality of life

    Assessed using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N Symptom Index)

    Minimum: 0 Maximum: 40 Higher score= worse head and neck cancer symptoms

    Measured: Changes from baseline to 12 weeks

  13. Cancer Symptom Burden

    Assessed using the revised Edmonton Symptom Assessment System (ESAS-r)

    Minimum: 0 Maximum: 100 Higher score= worse cancer symptoms

    Measured: Changes from baseline to 12 weeks

  14. Height

    Assessed using standing height without shoes.

    Minimum height: none Maximum height: none Taller: not specifically better or worse

    Measured: Changes from baseline to 12 weeks

  15. Weight

    Assessed using a digital scale without shoes.

    Minimum weight: none Maximum weight: none Higher weight: typically worse, but depends on other factors (ie. height, muscle mass, overall health status)

    Measured: Changes from baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start24 Nov 2020
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, safety and feasibility trial.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554667
Sponsor's protocol ID
20-0169
Acronym
LIFTING
Status last verified
Sep 2022
First submitted
11 Sep 2020
Last updated
6 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ntoukas SM, McNeely ML, Seikaly H, O'Connell D, Courneya KS. Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). Support Care Cancer. 2023 May 22;31(6):348. doi: 10.1007/s00520-023-07815-2.

    PubMed 37212970

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Exercise Intervention in people with Cancer of Head and Neck, 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 1 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 6 Sep 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Over 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554667, which also lists 1 linked publication.

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 6 Sep 2022.

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