Clinical trial NCT06289049: Heavy Strength Training in Head and Neck Cancer Survivors
Official title: Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
measure: Adherence to a heavy lifting strength training program
timeFrame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
measure: Completion of maximal strength testing
timeFrame: Baseline and postintervention (12 weeks)
measure: Followup assessment rate
timeFrame: Postintervention (12 weeks)
measure: Safety
timeFrame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Secondary outcomes:
measure: Muscular Strength
timeFrame: Baseline and Postintervention (12 weeks)
measure: Cancer Specific Quality of Life
timeFrame: Baseline and Postintervention (12 weeks)
measure: Fear of Cancer Recurrence
timeFrame: Baseline and Postintervention (12 weeks)
measure: Symptom Burden
timeFrame: Baseline and Postintervention (12 weeks)
measure: Perceived Stress
timeFrame: Baseline and Postintervention (12 weeks)
measure: Self-Esteem
timeFrame: Baseline and Postintervention (12 weeks)
measure: Sleep Habits
timeFrame: Baseline and Postintervention (12 weeks)
measure: Malnutrition Status
timeFrame: Baseline and Postintervention (12 weeks)
measure: Swallowing Abilities
timeFrame: Baseline and Postintervention (12 weeks)
measure: Shoulder Range of Motion
timeFrame: Baseline and Postintervention (12 weeks)
measure: Body composition
timeFrame: Baseline and Postintervention (12 weeks)
measure: Handgrip Strength
timeFrame: Baseline and Postintervention (12 weeks)
measure: Physical Function
timeFrame: Baseline and Postintervention (12 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Kerry Courneya
role: PRINCIPAL_INVESTIGATOR
References: