Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
- Conditions
- Gastro-esophageal Cancer
- Interventions
- Behavioral: Resistance trainingDietary Supplement: Protein supplement
- Registration Number
- NCT05650827
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction
- referred to first line chemotherapy.
- Age < 18
- Living outside the greater Copenhagen area
- Any other malignancy requiring active treatment
- Not eligible for chemotherapy
- Performance status > 2
- Not able to swallow liquids
- Parenteral nutrition or enteral nutrition via feeding tube
- Physical or mental disabilities that prohibit execution of test or training procedures
- Pregnancy
- Inability to understand the Danish language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and protein supplements intervention group Resistance training Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. The intervention consists of resistance training and a daily protein supplement. Exercise and protein supplements intervention group Protein supplement Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. The intervention consists of resistance training and a daily protein supplement.
- Primary Outcome Measures
Name Time Method Exercise feasibility: Exercise sessions attendance From baseline until end of intervention (10 weeks) The number of attended exercise training sessions relative to the number of planed exercise sessions
Exercise feasibility: Relative dose-intensity of protein supplement From baseline until end of intervention (10 weeks) The actual amount consumed relative to the amount prescribed over the intervention period
Incidence of Serious Adverse Events (SAEs). Baseline until end of intervention (10 weeks) 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.
- Secondary Outcome Measures
Name Time Method Functional performance: Habituel gait speed Baseline, end of week 10 Changes in habitual gait speed
Muscle strength: Chest press maximal muscle strenght Baseline, end of week 10 Changes in chest press 1RM
Body composition and anthropometrics: Skeletal muscle index At diagnose, after 10 weeks intervention and at 1 year follow up Changes in skeletal muscle index, assessed by diagnostic CT scans
Exercise feasibility: Relative dose intensity of exercise Baseline until end of intervention (10 weeks) The actual dose relative to the prescribed minimum dose
Exercise feasibility: Early termination of exercise sessions Baseline until end of intervention (10 weeks) Termination of an exercise session before the prescribed exercises have been performed
Body composition and anthropometrics: Muscle thickness Baseline, end of week 10 Changes in thickness of the vastus lateralis, assessed by ultrasound
Resting metabolic rate Baseline, end of week 10 Changes in resting metabolic rate
1 and 2-years cancer-specific survival Randomization to 1 and 2 years after randomization Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization
Health-related quality of life: Social well-being Baseline, 10 weeks-, 1 year-, and 2 years after randomization Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Body composition and anthropometrics: Total fat mass Baseline, end of week 10 Changes in total fat mass, assessed by DXA
Body composition and anthropometrics: Bone mineral density Baseline, end of week 10 Changes in bone mineral density, assessed by DXA
Body composition and anthropometrics: Skeletal muscle attenuation At diagnose, end of week 10 Changes in skeletal muscle attenuation, assessed by diagnostic CT scans
Body composition and anthropometrics: Adipose tissue index At diagnose, end of week 10 Changes in adipose tissue index, assessed by diagnostic CT scans
Exercise feasibility: Permanent discontinuation Baseline until end of intervention (10 weeks) Incidence of permanent withdrawal from the intervention before intervention period has ended.
Body composition and anthropometrics: Total lean mass Baseline, end of week 10 Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)
Body composition and anthropometrics: Appendicular lean mass Baseline, end of week 10 Changes in appendicular lean mass, assessed by DXA
Body composition and anthropometrics: Fat percentage Baseline, end of week 10 Changes in fat percentage, assessed by DXA
Body composition and anthropometrics: Body mass Baseline, end of week 10 Changes in body mass
Body composition and anthropometrics: Hip circumference Baseline, end of week 10 Changes in hip circumference
Body composition and anthropometrics: Waist circumference Baseline, end of week 10 Changes in waist circumference
Muscle strength: Leg press maximal muscle strenght Baseline, end of week 10 Changes in leg press one repetition maximum (1RM)
Heart rate Baseline, end of week 10 Changes in resting heart rate
Health-related quality of life: gastroesophageal cancer specific Baseline, 10 weeks-, 1 year-, and 2 years after randomization 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)
Self-reported physical activity: Sitting time Baseline, end of week 10 Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ
Exercise feasibility: Exercise intervention interruptions Baseline until end of intervention (10 weeks) Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session
Body composition and anthropometrics: Body mass index Baseline, end of week 10 Changes in body mass index
Muscle strength: Hand grip strenght Baseline, end of week 10 Changes in hand grip strength, assessed using a dynamometer
Functional performance: Maximal gait speed Baseline, end of week 10 Changes in maximal gait speed
Functional performance: Stair climb Baseline, end of week 10 Changes in stair climbing power
Blood pressure: Systolic blood pressure Baseline, end of week 10 Changes in systolic blood pressure
Blood pressure: Diastolic blood pressure Baseline, end of week 10 Changes in diastolic blood pressure
1 and 2-years over-all survival Randomization to 1 and 2 years after randomization Proportion of patients who have not died 1 and 2 years after randomization
Treatment tolerance: Number of series recieved 3, 6 and 9 weeks after randomization Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)
Health-related quality of life: Physical well-being Baseline, 10 weeks-, 1 year-, and 2 years after randomization 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)
Health-related quality of life: cancer cachexia specific Baseline, 10 weeks-, 1 year-, and 2 years after randomization 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)
Depression Baseline, 10 weeks-, 1 year-, and 2 years after randomization 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)
Treatment tolerance: Tolerated dose 3, 6 and 9 weeks after randomization Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Treatment tolerance: Permanent discontinuation of the treatment 3, 6 and 9 weeks after randomization Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Treatment effect: Response to chemotherapy Randomization to 2 years after randomization Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)
Health-related quality of life: Functional well-being Baseline,10 weeks-, 1 year-, 2 years after randomization Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Self-reported physical activity: Moderate intensity physical activity (PA) Baseline, end of week 10 Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ
Self-reported physical activity: Total PA Baseline, end of week 10 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)
Functional performance: Sit-to-stand Baseline, end of week 10 Changes in sit-to-stand power.
Progression-free survival Randomization to 2 years after randomization Time to progression
Treatment tolerance: Hospitalization 3, 6 and 9 weeks after randomization Unscheduled hospitalization
Treatment tolerance: Relative dose intensity 3, 6 and 9 weeks after randomization Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Health-related quality of life: Emotional well-being Baseline, 10 weeks-, 1 year-, and 2 years after randomization Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)
Anxiety Baseline, 10 weeks-, 1 year-, and 2 years after randomization Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)
Self-reported physical activity: Walking Baseline, end of week 10 Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)
Patient-reported symptomatic adverse events One week after each serie of chemotherapy during the intervention (10 weeks) Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Self-reported physical activity: Vigorous intensity PA Baseline, end of week 10 Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ
Self-reported screening of sarcopenia Baseline, end of week 10 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)
Self-reported three-days dietary records Baseline, week 5 and week 10 Changes in patient-reported three-day record of dietary intake assessed using questionnaries.
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark