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Exercise and Nutrition for Head and Neck Cancer Patients

NCT ID: NCT01681654

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of Head and Neck

Keywords

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Head/Neck Cancer Exercise Progressive Strength Training Quality of Life Cancer Randomized Controlled Trial Nutrition Lifestyle Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Lifestyle Intervention - Maintenance Program

Patients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Immediate Lifestyle Intervention - No Maintenance Program

Patients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Delayed Lifestyle Intervention - Maintenance Program

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.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Delayed Lifestyle Intervention - No Maintenance Program

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.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Cancer Foundation

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nicole Culos-Reed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Culos-Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Lauren C Capozzi, PhD Student

Role: STUDY_DIRECTOR

University of Calgary

Harold Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Centre, University of Calgary

Raylene Reimer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23031071 (View on PubMed)

Other Identifiers

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ENHANCE10001991

Identifier Type: -

Identifier Source: org_study_id