Exercise and Nutrition for Head and Neck Cancer Patients
ENHANCE
1 other identifier
interventional
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 26, 2016
October 1, 2016
2.2 years
August 31, 2012
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Body Composition
DXA Scan will be used to assess body composition
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Secondary Outcomes (16)
Quality of Life
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Physical Activity Behaviour
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Smoking History
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Depression
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Karnofsky Performance Score (KPS)
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
- +11 more secondary outcomes
Study Arms (4)
Immediate Lifestyle Intervention - Maintenance Program
EXPERIMENTALPatients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program.
Immediate Lifestyle Intervention - No Maintenance Program
EXPERIMENTALPatients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention.
Delayed Lifestyle Intervention - Maintenance Program
EXPERIMENTALPatients 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.
Delayed Lifestyle Intervention - No Maintenance Program
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Alberta Cancer Foundationcollaborator
Study Sites (2)
University of Calgary
Calgary, Alberta, T2N1N4, Canada
Tom Baker Cancer Centre
Calgary, Alberta, T2N4N2, Canada
Related Publications (1)
Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.
PMID: 23031071DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Culos-Reed, PhD
University of Calgary
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 10, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
October 26, 2016
Record last verified: 2016-10