Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial

Abstract Background Head and neck cancer patients undergoing concomitant chemoradiotherapy (CCRT) frequently experience loss of muscle mass and reduced functional performance. Positive effects of exercise training are reported for many cancer types but biological mechanisms need further elucidation....

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Main Authors: Camilla K. Lonkvist, Simon Lønbro, Anders Vinther, Bo Zerahn, Eva Rosenbom, Hanne Primdahl, Pernille Hojman, Julie Gehl
Format: Article
Language:English
Published: BMC 2017-06-01
Series:BMC Cancer
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12885-017-3388-0
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author Camilla K. Lonkvist
Simon Lønbro
Anders Vinther
Bo Zerahn
Eva Rosenbom
Hanne Primdahl
Pernille Hojman
Julie Gehl
author_facet Camilla K. Lonkvist
Simon Lønbro
Anders Vinther
Bo Zerahn
Eva Rosenbom
Hanne Primdahl
Pernille Hojman
Julie Gehl
author_sort Camilla K. Lonkvist
collection DOAJ
description Abstract Background Head and neck cancer patients undergoing concomitant chemoradiotherapy (CCRT) frequently experience loss of muscle mass and reduced functional performance. Positive effects of exercise training are reported for many cancer types but biological mechanisms need further elucidation. This randomized study investigates whether progressive resistance training (PRT) may attenuate loss of muscle mass and functional performance. Furthermore, biochemical markers and muscle biopsies will be investigated trying to link biological mechanisms to training effects. Methods At the Departments of Oncology at Herlev and Aarhus University Hospitals, patients with stage III/IV squamous cell carcinoma of the head and neck, scheduled for CCRT are randomized 1:1 to either a 12-week PRT program or control group, both with 1 year follow-up. Planned enrollment is 72 patients, and stratification variables are study site, sex, p16-status, and body mass index. Primary endpoint is difference in change in lean body mass (LBM) after 12 weeks of PRT, assessed by dual-energy X-ray absorptiometry (DXA). The hypothesis is that 12 weeks of PRT can attenuate the loss of LBM by at least 25%. Secondary endpoints include training adherence, changes in body composition, muscle strength, functional performance, weight, adverse events, dietary intake, self-reported physical activity, quality of life, labor market affiliation, blood biochemistry, plasma cytokine concentrations, NK-cell frequency in blood, sarcomeric protein content in muscles, as well as muscle fiber type and fiber size in muscle biopsies. Muscle biopsies are optional. Discussion This randomized study investigates the impact of a 12-week progressive resistance training program on lean body mass and several other physiological endpoints, as well as impact on adverse events and quality of life. Furthermore, a translational approach is integrated with extensive biological sampling and exploration into cytokines and mechanisms involved. The current paper discusses decisions and methods behind exercise in head and neck cancer patients undergoing concomitant chemoradiotherapy. Trial registration Approved by the Regional Ethics Committee for the Capital Region of Denmark (protocol id: H-15003725) and registered retrospectively at ClinicalTrials.gov ( NCT02557529 ) September 11th 2015.
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spelling doaj.art-29e6ca5fb7da44eb8d541f90326222952022-12-22T03:10:35ZengBMCBMC Cancer1471-24072017-06-0117111110.1186/s12885-017-3388-0Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trialCamilla K. Lonkvist0Simon Lønbro1Anders Vinther2Bo Zerahn3Eva Rosenbom4Hanne Primdahl5Pernille Hojman6Julie Gehl7Department of Oncology, Herlev and Gentofte Hospital, University of CopenhagenDepartment of Experimental Clinical Oncology, Aarhus University HospitalDepartment of Rehabilitation, Herlev and Gentofte Hospital, University of CopenhagenDepartment of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of CopenhagenNutritional Research Unit, Herlev and Gentofte Hospital, University of CopenhagenDepartment of Oncology, Aarhus University HospitalCentre of Inflammation and Metabolism (CIM) and Centre for Physical Activity Research (CFAS), Department of Infectious Diseases, Rigshospitalet, University of CopenhagenDepartment of Oncology, Herlev and Gentofte Hospital, University of CopenhagenAbstract Background Head and neck cancer patients undergoing concomitant chemoradiotherapy (CCRT) frequently experience loss of muscle mass and reduced functional performance. Positive effects of exercise training are reported for many cancer types but biological mechanisms need further elucidation. This randomized study investigates whether progressive resistance training (PRT) may attenuate loss of muscle mass and functional performance. Furthermore, biochemical markers and muscle biopsies will be investigated trying to link biological mechanisms to training effects. Methods At the Departments of Oncology at Herlev and Aarhus University Hospitals, patients with stage III/IV squamous cell carcinoma of the head and neck, scheduled for CCRT are randomized 1:1 to either a 12-week PRT program or control group, both with 1 year follow-up. Planned enrollment is 72 patients, and stratification variables are study site, sex, p16-status, and body mass index. Primary endpoint is difference in change in lean body mass (LBM) after 12 weeks of PRT, assessed by dual-energy X-ray absorptiometry (DXA). The hypothesis is that 12 weeks of PRT can attenuate the loss of LBM by at least 25%. Secondary endpoints include training adherence, changes in body composition, muscle strength, functional performance, weight, adverse events, dietary intake, self-reported physical activity, quality of life, labor market affiliation, blood biochemistry, plasma cytokine concentrations, NK-cell frequency in blood, sarcomeric protein content in muscles, as well as muscle fiber type and fiber size in muscle biopsies. Muscle biopsies are optional. Discussion This randomized study investigates the impact of a 12-week progressive resistance training program on lean body mass and several other physiological endpoints, as well as impact on adverse events and quality of life. Furthermore, a translational approach is integrated with extensive biological sampling and exploration into cytokines and mechanisms involved. The current paper discusses decisions and methods behind exercise in head and neck cancer patients undergoing concomitant chemoradiotherapy. Trial registration Approved by the Regional Ethics Committee for the Capital Region of Denmark (protocol id: H-15003725) and registered retrospectively at ClinicalTrials.gov ( NCT02557529 ) September 11th 2015.http://link.springer.com/article/10.1186/s12885-017-3388-0Head and neck cancerHead and neck squamous cell carcinomaChemoradiotherapyProgressive resistance trainingExercisePhysical activity
spellingShingle Camilla K. Lonkvist
Simon Lønbro
Anders Vinther
Bo Zerahn
Eva Rosenbom
Hanne Primdahl
Pernille Hojman
Julie Gehl
Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
BMC Cancer
Head and neck cancer
Head and neck squamous cell carcinoma
Chemoradiotherapy
Progressive resistance training
Exercise
Physical activity
title Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
title_full Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
title_fullStr Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
title_full_unstemmed Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
title_short Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial
title_sort progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy design of the dahanca 31 randomized trial
topic Head and neck cancer
Head and neck squamous cell carcinoma
Chemoradiotherapy
Progressive resistance training
Exercise
Physical activity
url http://link.springer.com/article/10.1186/s12885-017-3388-0
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