- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681654
Exercise and Nutrition for Head and Neck Cancer Patients (ENHANCE)
October 24, 2016 updated by: Dr. Nicole Culos-Reed, University of Calgary
Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations.
This translates into a lack of clinical programming available for these patient populations.
Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning.
To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes.
A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population.
Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program.
Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life.
In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work.
The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs.
delayed) as well as in those who receive the maintenance program (vs.
no maintenance).
This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
-
Calgary, Alberta, Canada, T2N4N2
- Tom Baker Cancer Centre
-
Calgary, Alberta, Canada, T2N1N4
- University of Calgary
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 Years of Age
- Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
- Will receive radiation as part of treatment plan
- Able to walk without assistance
- Received clearance for exercise from treating oncologist
- Lives in Calgary, Alberta area
- Can speak and write English
- Is interested in participating in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Lifestyle Intervention - Maintenance Program
Patients will receive a 12-week lifestyle program during treatment.
Patients will also receive maintenance support following the 12-week program.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
|
Experimental: Immediate Lifestyle Intervention - No Maintenance Program
Patients will begin the 12-week lifestyle intervention during treatment.
Patients will not receive a maintenance support following the 12-week intervention.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
|
Experimental: Delayed Lifestyle Intervention - Maintenance Program
Patients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis).
Patients will then receive maintenance support following the 12-week program.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
|
Experimental: Delayed Lifestyle Intervention - No Maintenance Program
Patients will receive a 12-week lifestyle intervention program following treatment completion (12 weeks following diagnosis).
Patients will not receive maintenance support following the 12-week program.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Body Composition
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
DXA Scan will be used to assess body composition
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Quality of Life will be assessed using the Functional Assessment of Cancer Therapy- Anemia module (FACT-AN), and the NCCN-FACT Fact Head/Neck Symptom Index-22 (FHNSI-22).
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Physical Activity Behaviour
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Physical activity will be assessed using Godin's (Godin, 1985) leisure score index (LSI) of the GLTEQ (Godin Leisure Time Exercise Questionnaire).
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Smoking History
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Smoking history will be assessed by a self report questionnaire which will classify patients as non-smokers, former smokers and current smokers.
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Depression
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Depression will be assessed using the Center for Epidemiological Studies on Depression Scale (CES-D).
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Karnofsky Performance Score (KPS)
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
The Karnofsky Performance Score (KSP) will be used to measure the participant's general ability to accomplish tasks of daily-living and overall well-being.
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Inflammatory Markers
Time Frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Inflammatory factors will be evaluated as they are associated with cancer cachexia and muscle wasting and may be modified by exercise (Seruga et al., 2008; Baldwin, 2011).
An overnight fasted blood draw will be collected at baseline, 3 months post diagnosis, 6 months post diagnosis, 9 months post diagnosis, and 12 months post diagnosis.
Serum inflammatory cytokine concentrations will be assessed in-house (Dr.
Raylene Reimer's laboratory) according to our established protocols.
TNF, IL-6, IL-1, IL-8 and C-reactive protein will be quantified using Milliplex Human Cytokine kits (Millipore, Billerica, MA).
Plate reading will be provided as a fee-for service through Eve Technologies Inc. (Calgary, AB).
|
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
|
Cancer related Symptom Management
Time Frame: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
|
Participants will complete the ESAS bi-weekly, before and after class.
The ESAS is a valid and reliable assessment tool to evaluate the nine more common symptoms experienced by cancer patients (Chang et al., 2000).
|
At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
|
Diet Behaviour - 3 Day food record
Time Frame: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
|
The 3-Day Diet Record is said to be the most accurate for mean macronutrient content and appropriate for use in studies where subjects may consume a wide variety of foods (American Dietetics Association / Dietitians Canada, 2000).
Participants are instructed to record their daily consumption over a period of three days, one of which must be a weekend day.
Written instructions and a sample entry are provided to increase accuracy of the daily record.
|
At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
|
Diet Behaviour: PG-SGA
Time Frame: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
|
The PG-SGA assessment tool has been show to improve treatment outcomes, decrease side-effects, and improve weight-management in cancer patients, and therefore will be used weekly to assess and identify malnutrition among patients (McMahon et al., 2000; Doyle et al., 2006).
|
At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
|
Health related Fitness Measures - Resting Heart Rate
Time Frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
|
Resting heart rate will be measured by palpating the radial artery and taking a 15 second count as per the CPAFLA protocol (CPAFLA, 2003).
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At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
|
Health Related Fitness Outcome - Blood Pressure
Time Frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
|
A resting blood pressure (mmHg) will be measured in duplicate on the left arm using a sphygmomanometer and stethoscope using standardized procedures (CPAFLA, 2003).
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At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
|
Health Related Fitness Outcome - 6 minute walk test
Time Frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
|
The six-minute walk test (6MWT) will be used to assess changes in functional aerobic capacity.
Using the standardized protocol, participants will be asked to walk as far as they can around a 400-meter track for six minutes [43].
The point reached at 6 minutes will be marked and measured to the nearest 0.5 meter.
Rating of perceived exertion (Borg scale) will be completed immediately after completion of the functional aerobic capacity test.
|
At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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Health Related Fitness Outcome - Grip Strength
Time Frame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
|
Muscular strength will be assessed using a combined grip strength of the right and left hands will also be assessed using a hand dynamometer.
A sum will be determined in kilograms from the best score of 2 trials recorded for each hand according to the CPAFLA protocol.
|
At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
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Health Related Fitness Outcome - Lower Body Strength
Time Frame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
|
Lower body strength will be assessed using a 30-second sit to stand test.
The number of times participants can stand from a seated position in 30-second will be examined.
|
At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
|
Health Related Fitness Outcome - Flexibility
Time Frame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
|
Flexibility will be assessed by a trunk forward flexion sit-and-reach test using a Wells-Dillon flexometer.
The test will follow a standard protocol, with two trials allowed and the highest score to the nearest 0.5 cm recorded.
|
At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
|
Health Related Fitness Outcome - Balance
Time Frame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
|
Balance will be assessed using a static balance test.
The test requires the participant to balance on one foot and then the other as long as they can (length of time to a maximum of 45 seconds) while standing on a 2.54 by 2.54 by 30.5 cm base using a standardized protocol, reported by Fleishman.
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At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lauren C Capozzi, PhD Student, University of Calgary
- Principal Investigator: Harold Lau, MD, Tom Baker Cancer Centre, University of Calgary
- Principal Investigator: Raylene Reimer, PhD, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 31, 2012
First Submitted That Met QC Criteria
September 5, 2012
First Posted (Estimate)
September 10, 2012
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENHANCE10001991
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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