Exercise and Nutrition for Head and Neck Cancer Patients

Cancer of Head and Neck Clinical Trial

— ENHANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681654
• Other study ID #: ENHANCE10001991
• Status: Completed
• Phase: N/A
• First received: August 31, 2012
• Last updated: October 24, 2016
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life	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	No
Secondary	Physical Activity Behaviour	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	No
Secondary	Smoking History	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	No
Secondary	Depression	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	No
Secondary	Karnofsky Performance Score (KPS)	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	No
Secondary	Inflammatory Markers	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	No
Secondary	Cancer related Symptom Management	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	No
Secondary	Diet Behaviour - 3 Day food record	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.	No
Secondary	Diet Behaviour: PG-SGA	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	No
Secondary	Health related Fitness Measures - Resting Heart Rate	Resting heart rate will be measured by palpating the radial artery and taking a 15 second count as per the CPAFLA protocol (CPAFLA, 2003).	At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.	No
Secondary	Health Related Fitness Outcome - Blood Pressure	A resting blood pressure (mmHg) will be measured in duplicate on the left arm using a sphygmomanometer and stethoscope using standardized procedures (CPAFLA, 2003).	At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.	No
Secondary	Health Related Fitness Outcome - 6 minute walk test	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.	No
Secondary	Health Related Fitness Outcome - Grip Strength	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.	No
Secondary	Health Related Fitness Outcome - Lower Body Strength	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	No
Secondary	Health Related Fitness Outcome - Flexibility	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	No
Secondary	Health Related Fitness Outcome - Balance	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.	At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.	No