72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial. Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30. Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control. Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered. Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.
The PRT program will start about the onset of radiotherapy. The program consists of 7 exercises in training machines and involves the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. A pilot study (NCT02068950) showed feasibility of PRT during CCRT. In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake. Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 6 and 12 months follow-up. DXA scans for body composition will be performed using a Lunar iDXA (GE Healthcare). Blood samples will be drawn at regular intervals during the 12 weeks and at follow-up. Patient reported quality of life (EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-H\&N35) will also be registered. Muscle biopsies will be taken three times: at baseline, after treatment and after 12-weeks PRT. Study duration is expected to be 18 months and an additional 12 months for follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)
Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention
Weekly diet diary during the 12-weeks intervention
Department of Oncology, Copenhagen University hospital, Herlev
Herlev, Denmark
Change in LBM (lean body mass)
change in kilograms
Time frame: at 12-weeks post PRT
Change in LBM (lean body mass)
change in kilograms
Time frame: at 6 weeks, and 6 and 12 months post RT
Fat mass
change in kilograms
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Weight loss
in kilograms
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Patient reported pain
Measured by NRS-scale
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Patient reported Quality of Life
QLQ-C30 questionnaire
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Muscle strength
measured using chest press and leg press
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Chair rise
measured using 30 s. chair rise
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
arm curls
measured using 30 s. arm curls
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Stair climb
steps/sec
Time frame: at 6 and 12 weeks, 6 and 12 months
Compliance to PRT program
No. of attended sessions out of total
Time frame: at 12 weeks post PRT
Physical activity
measured by PAS (physical activity scale)
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Percent of patients with feeding tubes
Time frame: at 6 and 12 weeks, and 6 and 12 months post RT
Resumption of work
No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)
Time frame: At 12 months follow-up
Percent relapses
Percent of patients having relapse within 12 months after radiotherapy
Time frame: at 12 months follow-up
Cytokines
Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT.
Time frame: at 3, 6, 8, 10, and 12 weeks
Muscle biopsies
protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated.
Time frame: at 6 and 12 weeks, and at 12 months follow-up
Patient satisfaction
Study specific questionnaire regarding pros and cons of attending the study
Time frame: at 12 weeks
NK-cells
Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.
Time frame: at 3 and 12 weeks
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