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Trial Title:
Heavy Strength Training in Head and Neck Cancer Survivors
NCT ID:
NCT06289049
Condition:
Head and Neck Neoplasms
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Head and Neck Carcinoma
Conditions: Official terms:
Carcinoma
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Strength Training
Exercise
Quality of Life
Randomized Controlled Trial
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Masking description:
Participants and investigators will not be blinded to group assignment given the nature
of the intervention.
Intervention:
Intervention type:
Other
Intervention name:
Experimental
Description:
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.
Arm group label:
Exercise Group
Other name:
Exercise Group
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. 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:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Country:
Canada
Contact:
Last name:
Stephanie Ntoukas
Email:
ntoukas@ualberta.ca
Investigator:
Last name:
Kerry Courneya
Email:
Principal Investigator
Start date:
December 2024
Completion date:
April 2026
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06289049