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

24. oktober 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Body Composition
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Calgary

Samarbejdspartnere

Alberta Cancer Foundation

Efterforskere

  • Studieleder: Lauren C Capozzi, PhD Student, University of Calgary
  • Ledende efterforsker: Harold Lau, MD, Tom Baker Cancer Centre, University of Calgary
  • Ledende efterforsker: Raylene Reimer, PhD, University of Calgary

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

31. august 2012

Først indsendt, der opfyldte QC-kriterier

5. september 2012

Først opslået (Skøn)

10. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ENHANCE10001991

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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