Head and Neck Neoplasms, Weight Loss
Conditions
Keywords
Head and Neck Cancer, Concomitant chemoradiotherapy, Exercise Training, Progressive Resistance Training, Weight loss, Lean Body Mass, Body Composition
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALProgressive Resistance Training
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)
BEHAVIORALphysical activity
Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention
BEHAVIORALDiet diary
Weekly diet diary during the 12-weeks intervention
Sponsors
Aarhus University Hospital
Odense University Hospital
Danish Head and Neck Cancer Group
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy verified head and neck squamous cell carcinoma referred for primary curatively intended treatment. * Candidates for concomitant chemoradiotherapy (2Gyx33-34; 6F/W; weekly cisplatin 40mg/m2, max. 70 mg/weekly) according to Danish Head and Neck Cancer Group (DAHANCA) guidelines (T1-4, N1-3, M0) * Performance status 0-1 * At least 18 years of age.
Exclusion criteria
* BMI below 20.5 * diabetes * corticosteroid treatment for other diseases * Tonsillectomy within the last week before inclusion. * hemoglobin below 6 mmol/l * leucocytes below 2.5 x 10\^9 /l * thrombocytes below 50 x 10\^9 /l * comorbidities, social, familial or geographical conditions, that could compromise attendance or results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LBM (lean body mass) | at 12-weeks post PRT | change in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | at 6 and 12 weeks, and 6 and 12 months post RT | change in kilograms |
| Weight loss | at 6 and 12 weeks, and 6 and 12 months post RT | in kilograms |
| Patient reported pain | at 6 and 12 weeks, and 6 and 12 months post RT | Measured by NRS-scale |
| Patient reported Quality of Life | at 6 and 12 weeks, and 6 and 12 months post RT | QLQ-C30 questionnaire |
| Muscle strength | at 6 and 12 weeks, and 6 and 12 months post RT | measured using chest press and leg press |
| Chair rise | at 6 and 12 weeks, and 6 and 12 months post RT | measured using 30 s. chair rise |
| arm curls | at 6 and 12 weeks, and 6 and 12 months post RT | measured using 30 s. arm curls |
| Stair climb | at 6 and 12 weeks, 6 and 12 months | steps/sec |
| Change in LBM (lean body mass) | at 6 weeks, and 6 and 12 months post RT | change in kilograms |
| Physical activity | at 6 and 12 weeks, and 6 and 12 months post RT | measured by PAS (physical activity scale) |
| Percent of patients with feeding tubes | at 6 and 12 weeks, and 6 and 12 months post RT | — |
| Resumption of work | At 12 months follow-up | No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy) |
| Percent relapses | at 12 months follow-up | Percent of patients having relapse within 12 months after radiotherapy |
| Cytokines | at 3, 6, 8, 10, and 12 weeks | Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT. |
| Muscle biopsies | at 6 and 12 weeks, and at 12 months follow-up | protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated. |
| Patient satisfaction | at 12 weeks | Study specific questionnaire regarding pros and cons of attending the study |
| NK-cells | at 3 and 12 weeks | Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect. |
| Compliance to PRT program | at 12 weeks post PRT | No. of attended sessions out of total |
Countries
Denmark
Outcome results
None listed