Clinical trial NCT04554667: Heavy Lifting Strength Training in Head and Neck Cancer Survivors
Official title: Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer of Head and Neck
Keywords: surgery
neck dissection
strength training
survivors
exercise
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, safety and feasibility trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

Detailed description: RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.

OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.

METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.

SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.

Eligibility criteria: Inclusion Criteria:

* previously diagnosed with any subtype and stage of head and neck cancer
* at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
* adults ages 18 and older
* no unmanaged medical conditions, alcohol, and drug abuse
* approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
* ability to understand and communicate in English

Exclusion Criteria:

* having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise

Primary outcomes:
measure: Recruitment Rate
timeFrame: Over 12 weeks
measure: Muscular Strength
timeFrame: Changes from baseline to 12 weeks
measure: Program Adherence
timeFrame: Over 12 weeks
Secondary outcomes:
measure: Physical functioning
timeFrame: Changes from baseline to 12 weeks
measure: Fear of cancer recurrence
timeFrame: Changes from baseline to 12 weeks
measure: Post Traumatic Growth after cancer
timeFrame: Changes from baseline to 12 weeks
measure: Waist to hip ratio (body composition)
timeFrame: Changes from baseline to 12 weeks
measure: Anxiety
timeFrame: Changes from baseline to 12 weeks
measure: Fatigue
timeFrame: Changes from baseline to 12 weeks
measure: Stress
timeFrame: Changes from baseline to 12 weeks
measure: Shoulder Mobility
timeFrame: Changes from baseline to 12 weeks
measure: Self-Esteem
timeFrame: Changes from baseline to 12 weeks
measure: Sleep
timeFrame: Changes from baseline to 12 weeks
measure: Motivation
timeFrame: Changes from baseline to 12 weeks
measure: Cancer specific quality of life
timeFrame: Changes from baseline to 12 weeks
measure: Cancer Symptom Burden
timeFrame: Changes from baseline to 12 weeks
measure: Height
timeFrame: Changes from baseline to 12 weeks
measure: Weight
timeFrame: Changes from baseline to 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Kerry S Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
References: