Neoplasms

Digestive System Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Esophageal Neoplasms

Sarcopenia

Wasting Syndrome

Cachexia

Esophageal Cancer

Participants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark.

Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.

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.

10 weeks of resistance training 3 times pr. week.

Resistance training

A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight

Protein supplement

Rikke Krabek, MD

Rikke Krabek

Casper Simonsen, PhD

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.

Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

Changes in differential counts (total and per type: eosinofils, basofils, neutrofils, monocytes and lymphocytes)

Changes in low-density lipoprotein cholesterol

Changes in high-density lipoprotein cholesterol

Changes in glucose tolerance (2-hpur oral glucose tolerance test)

Muscle glucose uptake during insulin stimulation after acute exercise

Muscle protein synthesis during insulin stimulation after acute exercise.

Modifications of proteins after acute exercise. Muscle biopsies will be subjected to mass spectrometry-based proteomic analysis.

Modifications of mithochondrial regulation. Signaling of mitochondiral fission, fusion and mitophagy will be examined in mucle biopsies.

The number of attended exercise training sessions relative to the number of planed exercise sessions

The actual amount consumed relative to the amount prescribed over the intervention period

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.

The actual dose relative to the prescribed minimum dose

Termination of an exercise session before the prescribed exercises have been performed

Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session

Incidence of permanent withdrawal from the intervention before intervention period has ended.

Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)

Changes in appendicular lean mass, assessed by DXA

Changes in total fat mass, assessed by DXA

Changes in fat percentage, assessed by DXA

Changes in bone mineral density, assessed by DXA

Changes in thickness of the vastus lateralis, assessed by ultrasound

Changes in skeletal muscle index, assessed by diagnostic CT scans

Changes in skeletal muscle attenuation, assessed by diagnostic CT scans

Changes in adipose tissue index, assessed by diagnostic CT scans

Changes in leg press one repetition maximum (1RM)

Changes in hand grip strength, assessed using a dynamometer

Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization

Proportion of patients who have not died 1 and 2 years after randomization

Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)

Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)

Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)

Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)

Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)

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)

Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)

Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)

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)

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)

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)

Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)

Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)

Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ

Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ

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)

Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ

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)

Changes in patient-reported three-day record of dietary intake assessed using questionnaries.

Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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