Heavy Lifting Strength Training in Head and Neck Cancer Survivors

Cancer of Head and Neck Clinical Trial

— LIFTING  

Official title:

Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554667
• Other study ID #: 20-0169
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Behavioral:
• Exercise Intervention
Heavy Lifting Strength Training

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Recruitment rate (with reasons for refusal).; Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data	Over 12 weeks
Primary	Muscular Strength	Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests.; Minimum: none Maximum: none Higher score= better strength	Changes from baseline to 12 weeks
Primary	Program Adherence	Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence	Over 12 weeks
Secondary	Physical functioning	Assessed using the Neck Dissection Impairment Index (NDII) and maximum strength tests.; Minimum: 40 Maximum: 100 Higher score= worse impairment	Changes from baseline to 12 weeks
Secondary	Fear of cancer recurrence	Assessed using the Fear of Cancer Recurrence Inventory (FCRI); Minimum: 0 Maximum: 36 Higher score= worse fear of cancer recurrence	Changes from baseline to 12 weeks
Secondary	Post Traumatic Growth after cancer	How cancer has changed an individual's life will be assessed using the Post Traumatic Growth Inventory (PTGI); Minimum: 0 Maximum: 105 Higher score= better (positive) post traumatic growth transformation	Changes from baseline to 12 weeks
Secondary	Waist to hip ratio (body composition)	Assessed using waist to hip ratio (WHR) measure.; Minimum WHR: none Maximum WHR: none Higher score WHR= worse body composition	Changes from baseline to 12 weeks
Secondary	Anxiety	Assessed using the Spielberger State Trait Anxiety Inventory (STAI); Minimum: 20 Maximum: 80 Higher score= worse anxiety	Changes from baseline to 12 weeks
Secondary	Fatigue	Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire; Minimum: 0 Maximum: 52 Higher score=worse fatigue	Changes from baseline to 12 weeks
Secondary	Stress	Assessed using the Perceived Stress Scale (PSS); Minimum: 0 Maximum: 56 Higher score=worse perceived stress	Changes from baseline to 12 weeks
Secondary	Shoulder Mobility	Changes in shoulder mobility; Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years) Maximum: none Higher score= better mobility	Changes from baseline to 12 weeks
Secondary	Self-Esteem	Changes in level of self-esteem assessed using Rosenberg Self-Esteem (RSE) scale; Minimum: 10 Maximum: 40 Higher score= better self-esteem	Changes from baseline to 12 weeks
Secondary	Sleep	Changes in sleep patterns assessed using the insomnia severity index (ISI); Minimum: 0 Maximum: 28 Higher score= worse insomnia	Changes from baseline to 12 weeks
Secondary	Motivation	Questions based on the theory of planned behaviour; Minimum: 7 Maximum: 35 Higher score= better motivation	Changes from baseline to 12 weeks
Secondary	Cancer specific quality of life	Assessed using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N Symptom Index); Minimum: 0 Maximum: 40 Higher score= worse head and neck cancer symptoms	Changes from baseline to 12 weeks
Secondary	Cancer Symptom Burden	Assessed using the revised Edmonton Symptom Assessment System (ESAS-r); Minimum: 0 Maximum: 100 Higher score= worse cancer symptoms	Changes from baseline to 12 weeks
Secondary	Height	Assessed using standing height without shoes.; Minimum height: none Maximum height: none Taller: not specifically better or worse	Changes from baseline to 12 weeks
Secondary	Weight	Assessed using a digital scale without shoes.; Minimum weight: none Maximum weight: none Higher weight: typically worse, but depends on other factors (ie. height, muscle mass, overall health status)	Changes from baseline to 12 weeks