Heavy Strength Training in Head and Neck Cancer Survivors (LIFTING2)

University of Alberta

Status and phase: Enrolling; Phase 2

Conditions: Head and Neck Carcinoma; Head and Neck Neoplasms; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT06289049

HREBA.CC-24-0021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise Group

Experimental group

Description:

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.

Treatment:

Other: Experimental

Usual Care Group

No Intervention group

Description:

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