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

24 ottobre 2016 aggiornato da: Dr. Nicole Culos-Reed, University of Calgary

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Tom Baker Cancer Centre
      • Calgary, Alberta, Canada, T2N1N4
        • University of Calgary

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Body Composition
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
DXA Scan will be used to assess body composition
At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Physical Activity Behaviour
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Smoking History
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Depression
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Karnofsky Performance Score (KPS)
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Inflammatory Markers
Lasso di tempo: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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
Cancer related Symptom Management
Lasso di tempo: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
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
Diet Behaviour - 3 Day food record
Lasso di tempo: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
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.
Diet Behaviour: PG-SGA
Lasso di tempo: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
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
Health related Fitness Measures - Resting Heart Rate
Lasso di tempo: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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.
Health Related Fitness Outcome - Blood Pressure
Lasso di tempo: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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.
Health Related Fitness Outcome - 6 minute walk test
Lasso di tempo: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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.
Health Related Fitness Outcome - Grip Strength
Lasso di tempo: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
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.
Health Related Fitness Outcome - Lower Body Strength
Lasso di tempo: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
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
Health Related Fitness Outcome - Flexibility
Lasso di tempo: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
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
Health Related Fitness Outcome - Balance
Lasso di tempo: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Calgary

Collaboratori

Alberta Cancer Foundation

Investigatori

  • Direttore dello studio: Lauren C Capozzi, PhD Student, University of Calgary
  • Investigatore principale: Harold Lau, MD, Tom Baker Cancer Centre, University of Calgary
  • Investigatore principale: Raylene Reimer, PhD, University of Calgary

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

31 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

5 settembre 2012

Primo Inserito (Stima)

10 settembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ENHANCE10001991

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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