Clinical trial NCT01681654: Exercise and Nutrition for Head and Neck Cancer Patients
Official title: Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Head/Neck Cancer
Exercise
Progressive Strength Training
Quality of Life
Cancer
Randomized Controlled Trial
Nutrition
Lifestyle Intervention
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Cancer Foundation
First posted: 2012-09-10
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Body Composition
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Secondary outcomes:
measure: Quality of Life
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Physical Activity Behaviour
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Smoking History
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Depression
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Karnofsky Performance Score (KPS)
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Inflammatory Markers
timeFrame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
measure: Cancer related Symptom Management
timeFrame: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
measure: Diet Behaviour - 3 Day food record
timeFrame: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
measure: Diet Behaviour: PG-SGA
timeFrame: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
measure: Health related Fitness Measures - Resting Heart Rate
timeFrame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
measure: Health Related Fitness Outcome - Blood Pressure
timeFrame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
measure: Health Related Fitness Outcome - 6 minute walk test
timeFrame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
measure: Health Related Fitness Outcome - Grip Strength
timeFrame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
measure: Health Related Fitness Outcome - Lower Body Strength
timeFrame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
measure: Health Related Fitness Outcome - Flexibility
timeFrame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
measure: Health Related Fitness Outcome - Balance
timeFrame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Lauren C Capozzi, PhD Student
role: STUDY_DIRECTOR
affiliation: Tom Baker Cancer Centre, University of Calgary
name: Harold Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Raylene Reimer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.