Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
NCT ID: NCT05650827
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
54 participants
INTERVENTIONAL
2023-02-24
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Care Control
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.
No interventions assigned to this group
Exercise and protein supplements intervention group
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* referred to first line chemotherapy.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Rikke Krabek, MD
Principal Investigator
Principal Investigators
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Casper Simonsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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18.10.22
Identifier Type: -
Identifier Source: org_study_id
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