NCT03252821.

Study name	Effects of high‐intensity training compared to resistance training in cancer patients undergoing radiotherapy
Methods	Study design: RCT Country where trial is being conducted: Belgium
Participants	Inclusion criteria: primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer age over 18 years no distant metastases and/or disease progression at least 25 scheduled radiation treatments (5 weeks) ability to read, write, and speak French Exclusion criteria: uncontrolled cardiac, hypertensive or pulmonary diseases uncontrolled insulin‐dependent diabetes mellitus neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation abnormal electrocardiogram
Interventions	Intervention details Arm 1: high‐intensity aerobic training group will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session Arm 2: resistance training group muscle strengthening will incorporate eight exercises targeting major muscle groups at 60% to 85% of their estimated 1‐repetition maximum (1RM) Comparator details: no intervention, usual care
Outcomes	Primary outcome measures: Change in fatigue (FACIT‐fatigue questionnaire) Secondary outcome measures Change in functional capacity (6‐minute walk test) Change in quality of life (Functional Assessment of Cancer Therapy‐General) Change in sleep disturbances (Pittsburgh Sleep Quality Index) Change in somnolence syndrome (Epworth Sleepiness Scale) Change in insomnia (Insomnia Severity Index) Change in depression symptoms (Center for Epidemiologic Studies Depression Scale) Change in executive functions (Trail Making Test) Change in dyspnoea (Multidimensional Dyspnea Profile) Adherence (Percentage of completed sessions) Time points measured: baseline, 5 weeks for rectum cancer
Starting date	15 August 2017
Contact information	Gilles Caty gilles.caty@uclouvain.be Elise Piraux elise.piraux@uclouvain.be
Notes	Trial registration identifier: NCT03252821 Trial registration link: https://clinicaltrials.gov/ct2/show/NCT03252821 Sponsor: Cliniques universities Saint‐Luc‐ Université Catholique de Louvain