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

BMC Cancer

Study Protocol

Pernille Hojman¹  Bo Zerahn²  Simon Lønbro³  Hanne Primdahl⁴  Julie Gehl⁵  Camilla K. Lonkvist⁵  Anders Vinther⁶  Eva Rosenbom⁷ 

[1] Centre of Inflammation and Metabolism (CIM) and Centre for Physical Activity Research (CFAS), Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark;Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark;Department of Public Health, Section for Sports Science, Aarhus University, Aarhus, Denmark;Department of Oncology, Aarhus University Hospital, Aarhus, Denmark;Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark;Department of Rehabilitation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark;Nutritional Research Unit, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark;

关键词: Head and neck cancer;    Head and neck squamous cell carcinoma;    Chemoradiotherapy;    Progressive resistance training;    Exercise;    Physical activity;    Body composition;    Lean body mass;    Body weight;    Weight;   

DOI  :  10.1186/s12885-017-3388-0

 received in 2016-09-09, accepted in 2017-05-25,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundHead 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.MethodsAt 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.DiscussionThis 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 registrationApproved 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.

【 授权许可】

CC BY   
© The Author(s). 2017