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NCT05650827
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Conditions: Gastro-esophageal Cancer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 54
Sponsor: Rigshospitalet, Denmark
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 Criteria
Inclusion Criteria:histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junctionreferred to first line chemotherapy.Exclusion Criteria:Age < 18Living outside the greater Copenhagen areaAny other malignancy requiring active treatmentNot eligible for chemotherapyPerformance status > 2Not able to swallow liquidsParenteral nutrition or enteral nutrition via feeding tubePhysical or mental disabilities that prohibit execution of test or training proceduresPregnancyInability to understand the Danish language
Source: ClinicalTrials.gov (NCT05650827). StuddyBuddy aggregates publicly available trial information.