Clinical trial NCT02647021: Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors
Official title: Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Accessory Nerve Injury
Fatigue
Keywords: physical therapy
cancer rehabilitation
exercise
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2016-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Detailed description: Participants will be stratified by early (within 18 months of surgery) and late (\> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.

The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.

At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
* Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
* Presenting with shoulder and/ or neck dysfunction related to cancer treatment
* Karnofsky Performance Status greater than or equal to 60%
* No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
* Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
* Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.

Exclusion Criteria:

* A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
timeFrame: change from baseline to 12 weeks.
Secondary outcomes:
measure: Shoulder range of motion in degrees.
timeFrame: Change from baseline to one year
measure: Body mass index
timeFrame: Change from baseline to 24 weeks.
measure: 1 repetition maximum (1RM) strength for seated row in pounds.
timeFrame: Change from baseline to 12 weeks.
measure: Neck Range of Motion in degrees.
timeFrame: Change from baseline to 12 weeks.
measure: Upper extremity muscular endurance: number of repetitions performed.
timeFrame: baseline, 12-weeks, 24-weeks, one year
measure: Lower extremity flexibility in centimetres.
timeFrame: Change from baseline to 12-weeks.
measure: Functional capacity
timeFrame: Change from baseline to 24 weeks.
measure: Neck Dissection Impairment Index
timeFrame: Change from baseline to one year.
measure: Grip strength in pounds.
timeFrame: Change from baseline to 12-weeks.
measure: 1 repetition maximum leg press in pounds
timeFrame: Change from baseline to 12 weeks.
measure: 1 repetition maximum chest press in pounds.
timeFrame: Change from baseline to 12 weeks.
measure: 30 second sit to stand (optional: in lieu of leg press)
timeFrame: Change from baseline to 12 weeks.
measure: Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
timeFrame: Baseline to 12-weeks.
Other outcomes:
measure: Physical activity level in minutes per week (average over the previous one month period).
timeFrame: Change in monthly average physical activity from baseline to one year.
measure: Cost of programming
timeFrame: one year
measure: Exercise Adherence
timeFrame: Change from baseline to 1 year.
measure: Functional Assessment of Cancer Therapy Fatigue Scale at one year.
timeFrame: Change from baseline to 1 year.
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret L. McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: