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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

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