NCT01681654

Exercise and Nutrition for Head and Neck Cancer Patients

Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Head and Neck

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle 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.
BEHAVIORAL	Maintenance 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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2012-09-10
• Last updated: 2016-10-26

Locations

2 sites across 1 country: Canada