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

Condition(s) studied

Investigational drug(s) / intervention(s)

Resistance training: 10 weeks of resistance training 3 times pr. week.

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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