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

Last updated: May 8, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Resistance training

Protein supplement

Clinical Study ID

NCT05650827
18.10.22
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • histologically verified, non-resectable cancer of the esophagus, stomach, orgastroesophageal junction

  • referred to first line chemotherapy.

Exclusion

Exclusion Criteria:

  • 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 trainingprocedures

  • Pregnancy

  • Inability to understand the Danish language

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Resistance training
Phase:
Study Start date:
February 24, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

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