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Exercise and Nutrition for Head and Neck Cancer Patients (ENHANCE)

U

University of Calgary

Status

Completed

Conditions

Cancer of Head and Neck

Treatments

Behavioral: Maintenance Intervention
Behavioral: Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01681654
ENHANCE10001991

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups

Immediate Lifestyle Intervention - Maintenance Program
Experimental group
Description:
Patients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program.
Treatment:
Behavioral: Maintenance Intervention
Behavioral: Lifestyle Intervention
Immediate Lifestyle Intervention - No Maintenance Program
Experimental group
Description:
Patients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention.
Treatment:
Behavioral: Lifestyle Intervention
Delayed Lifestyle Intervention - Maintenance Program
Experimental group
Description:
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.
Treatment:
Behavioral: Maintenance Intervention
Behavioral: Lifestyle Intervention
Delayed Lifestyle Intervention - No Maintenance Program
Experimental group
Description:
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.
Treatment:
Behavioral: Lifestyle Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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