Heavy Strength Training in Head and Neck Cancer Survivors

NCT06289049 | Recruiting Phase 2

• 1 other identifier: HREBA.CC-24-0021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Recruitment range: 40 to 60 participants; Higher=better and more available data

  Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

• Adherence to a heavy lifting strength training program

  Adherence rate: 0 to 100 percent of exercise sessions; Higher=better

  Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

• Completion of maximal strength testing

  3 repetition maximum testing rate: 0 to 100 percent; Higher=better

  Baseline and postintervention (12 weeks)

• Followup assessment rate

  Followup assessment rate: 0 to 100 percent; Higher=better

  Postintervention (12 weeks)

• Safety

  Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse

  Baseline, postintervention (12 weeks), and monitored throughout 12 week study period

Secondary Outcomes (13)

• Muscular Strength

  Baseline and Postintervention (12 weeks)

• Cancer Specific Quality of Life

  Baseline and Postintervention (12 weeks)

• Fear of Cancer Recurrence

  Baseline and Postintervention (12 weeks)

• Symptom Burden

  Baseline and Postintervention (12 weeks)

• Perceived Stress

  Baseline and Postintervention (12 weeks)

Study Arms (2)

Exercise Group

EXPERIMENTAL

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.

Other: Experimental

Usual Care Group

NO INTERVENTION

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

Interventions

Experimental OTHER

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.

Also known as: Exercise Group

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Behavior

Study Officials

• Kerry Courneya

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ntoukas

CONTACT

7804922829; ntoukas@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will not be blinded to group assignment given the nature of the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: February 17, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)