Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death. Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy. A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
10 weeks of resistance training 3 times pr. week.
A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight
Rigshospitalet
Copenhagen, Denmark
Exercise feasibility: Exercise sessions attendance
The number of attended exercise training sessions relative to the number of planed exercise sessions
Time frame: From baseline until end of intervention (10 weeks)
Exercise feasibility: Relative dose-intensity of protein supplement
The actual amount consumed relative to the amount prescribed over the intervention period
Time frame: From baseline until end of intervention (10 weeks)
Incidence of Serious Adverse Events (SAEs).
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.
Time frame: Baseline until end of intervention (10 weeks)
Exercise feasibility: Relative dose intensity of exercise
The actual dose relative to the prescribed minimum dose
Time frame: Baseline until end of intervention (10 weeks)
Exercise feasibility: Early termination of exercise sessions
Termination of an exercise session before the prescribed exercises have been performed
Time frame: Baseline until end of intervention (10 weeks)
Exercise feasibility: Exercise intervention interruptions
Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session
Time frame: Baseline until end of intervention (10 weeks)
Exercise feasibility: Permanent discontinuation
Incidence of permanent withdrawal from the intervention before intervention period has ended.
Time frame: Baseline until end of intervention (10 weeks)
Body composition and anthropometrics: Total lean mass
Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Appendicular lean mass
Changes in appendicular lean mass, assessed by DXA
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Total fat mass
Changes in total fat mass, assessed by DXA
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Fat percentage
Changes in fat percentage, assessed by DXA
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Bone mineral density
Changes in bone mineral density, assessed by DXA
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Muscle thickness
Changes in thickness of the vastus lateralis, assessed by ultrasound
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Skeletal muscle index
Changes in skeletal muscle index, assessed by diagnostic CT scans
Time frame: At diagnose, after 10 weeks intervention and at 1 year follow up
Body composition and anthropometrics: Skeletal muscle attenuation
Changes in skeletal muscle attenuation, assessed by diagnostic CT scans
Time frame: At diagnose, end of week 10
Body composition and anthropometrics: Adipose tissue index
Changes in adipose tissue index, assessed by diagnostic CT scans
Time frame: At diagnose, end of week 10
Body composition and anthropometrics: Body mass
Changes in body mass
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Body mass index
Changes in body mass index
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Hip circumference
Changes in hip circumference
Time frame: Baseline, end of week 10
Body composition and anthropometrics: Waist circumference
Changes in waist circumference
Time frame: Baseline, end of week 10
Muscle strength: Leg press maximal muscle strenght
Changes in leg press one repetition maximum (1RM)
Time frame: Baseline, end of week 10
Muscle strength: Chest press maximal muscle strenght
Changes in chest press 1RM
Time frame: Baseline, end of week 10
Muscle strength: Hand grip strenght
Changes in hand grip strength, assessed using a dynamometer
Time frame: Baseline, end of week 10
Functional performance: Habituel gait speed
Changes in habitual gait speed
Time frame: Baseline, end of week 10
Functional performance: Maximal gait speed
Changes in maximal gait speed
Time frame: Baseline, end of week 10
Functional performance: Sit-to-stand
Changes in sit-to-stand power.
Time frame: Baseline, end of week 10
Functional performance: Stair climb
Changes in stair climbing power
Time frame: Baseline, end of week 10
Resting metabolic rate
Changes in resting metabolic rate
Time frame: Baseline, end of week 10
Blood pressure: Systolic blood pressure
Changes in systolic blood pressure
Time frame: Baseline, end of week 10
Blood pressure: Diastolic blood pressure
Changes in diastolic blood pressure
Time frame: Baseline, end of week 10
Heart rate
Changes in resting heart rate
Time frame: Baseline, end of week 10
1 and 2-years cancer-specific survival
Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization
Time frame: Randomization to 1 and 2 years after randomization
1 and 2-years over-all survival
Proportion of patients who have not died 1 and 2 years after randomization
Time frame: Randomization to 1 and 2 years after randomization
Progression-free survival
Time to progression
Time frame: Randomization to 2 years after randomization
Treatment tolerance: Hospitalization
Unscheduled hospitalization
Time frame: 3, 6 and 9 weeks after randomization
Treatment tolerance: Relative dose intensity
Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Time frame: 3, 6 and 9 weeks after randomization
Treatment tolerance: Number of series recieved
Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)
Time frame: 3, 6 and 9 weeks after randomization
Treatment tolerance: Tolerated dose
Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Time frame: 3, 6 and 9 weeks after randomization
Treatment tolerance: Permanent discontinuation of the treatment
Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Time frame: 3, 6 and 9 weeks after randomization
Treatment effect: Response to chemotherapy
Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)
Time frame: Randomization to 2 years after randomization
Health-related quality of life: Physical well-being
Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) (scale-scoring 0-28, the higher the score the better quality of life)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Health-related quality of life: Social well-being
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Health-related quality of life: Emotional well-being
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Health-related quality of life: Functional well-being
Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Time frame: Baseline,10 weeks-, 1 year-, 2 years after randomization
Health-related quality of life: gastroesophageal cancer specific
Changes in patient-reported gastroesophageal cancer specific well-being assessed using FACT-E (scale-scoring 0-68, the higher the score the better quality of life)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Health-related quality of life: cancer cachexia specific
Changes in patient-reported cancer cachexia specific well-being assessed using Functional Assessment of Cancer Therapy - Cancer Cachexia (scale-scoring 0-48, the higher the score the better quality of life)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Depression
Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Anxiety
Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)
Time frame: Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Self-reported physical activity: Walking
Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, end of week 10
Self-reported physical activity: Moderate intensity physical activity (PA)
Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ
Time frame: Baseline, end of week 10
Self-reported physical activity: Vigorous intensity PA
Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ
Time frame: Baseline, end of week 10
Self-reported physical activity: Total PA
Changes in patient-reported weekly duration of total PA, assessed using the IPAQ (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)
Time frame: Baseline, end of week 10
Self-reported physical activity: Sitting time
Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ
Time frame: Baseline, end of week 10
Self-reported screening of sarcopenia
Changes in patient-reported signs of sarcopenia, assessed using The Strength, assistance in walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire (scale scoring: 0-10, the higher the score the better the condition)
Time frame: Baseline, end of week 10
Self-reported three-days dietary records
Changes in patient-reported three-day record of dietary intake assessed using questionnaries.
Time frame: Baseline, week 5 and week 10
Patient-reported symptomatic adverse events
Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: One week after each serie of chemotherapy during the intervention (10 weeks)
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