Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy
- Conditions
- Head and Neck NeoplasmsWeight Loss
- Interventions
- Behavioral: physical activityBehavioral: Progressive Resistance TrainingBehavioral: Diet diary
- Registration Number
- NCT02557529
- Lead Sponsor
- Herlev Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Progressive Resistance Training Diet diary 12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary. Control physical activity Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary. Progressive Resistance Training Progressive Resistance Training 12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary. Progressive Resistance Training physical activity 12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary. Control Diet diary Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.
- Primary Outcome Measures
Name Time Method Change in LBM (lean body mass) at 12-weeks post PRT change in kilograms
- Secondary Outcome Measures
Name Time Method Fat mass at 6 and 12 weeks, and 6 and 12 months post RT change in kilograms
Change in LBM (lean body mass) at 6 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
Compliance to PRT program at 12 weeks post PRT No. of attended sessions out of total
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.
Trial Locations
- Locations (1)
Department of Oncology, Copenhagen University hospital, Herlev
🇩🇰Herlev, Denmark