cancer of the upper GI tract, gastroesophageal cancer cancer of esophagus and/or stomach
Conditions
Interventions
The intervention in this study is a 12-week exercise and nutrition
intervention. Exercise intervention: the patient trains for an hour twice a
week under the supervision of a physiotherapist in the
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Incurable adenocarcinoma of the esophagus or stomach. • Progressive disease after treatment with curative intent OR metastatic disease at primary diagnosis. • Able and willing to perform the exercise and nutritional program and wear the activity tracker. • Able and willing to fill out the POCOP/RADICES questionnaires. • Life expectancy > 12 weeks • Age >= 18 years.
Exclusion criteria
Exclusion criteria: • Unstable bone metastases inducing skeletal fragility as determined by the treating clinician. • Untreated symptomatic known brain metastasis. • Serious active infection. • Too physically active (i.e. >210 minutes/week of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program. • Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria. • Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise. • Uncontrolled severe pain. • Any other contraindications for exercise as determined by the treating physician. • Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician. • Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical effects 1. Aerobic capacity 2. Muscle strength 3. Muscle mass and fat mass 4. Weight 5. Nutritional status including sarcopenia 6. Physical activity 7. Toxicity 8. WHO performance status Patient reported outcomes 1. Physical activity 2. Physical functioning, role functioning and fatigue Medical effects 1. Percentage of patients starting systemic treatment 2. Dose reductions and delays 3. Duration of systemic therapy 4. Progression free and overall survival Exploratory endpoints 1. Other Patient Reported Outcomes as measured by the POCOP questionnaire 2. Dietary intake 3. Cost efficacy Intervention group only: 1. (Serious) Adverse events potentially related to the exercise intervention 2. Satisfaction with the exercise and nutritional intervention (intervention group only) 3. Adherence and compliance to the exercise and diet intervention | — |
Countries
Netherlands
Contacts
Public ContactA Bonhof
Amsterdam UMC
Outcome results
None listed