Phase
Condition
Digestive System Neoplasms
Esophageal Disorders
Treatment
Nutrition intervention
Exercise intervention
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Incurable adenocarcinoma of the esophagus or stomach.
Progressive disease after first-line palliative systemic treatment OR within 6months after completion of curative treatment (i.e. within six months afterneoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation foresophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil,leucovorin, oxaliplatin and docetaxel (FLOT) for gastric/esophageal cancer orneoadjuvant FLOT if no adjuvant FLOT was given, or after progression duringparticipation in the LyRICX study). Patients on capecitabine monotherapy who areeligible for oxaliplatin reintroduction can be included, too. Inclusion can takeplace regardless of the plan or the actual initiation of multi-line systemictreatment. (i.e. patients that have already started with second/third/etc. linetherapy are eligible for inclusion too)
Able and willing to perform the exercise and nutritional program and wear theactivity tracker.
Able and willing to fill out the POCOP/RADICES questionnaires.
Life expectancy > 12 weeks.
Age ≥ 18 years.
Exclusion
Exclusion Criteria:
Unstable bone metastases inducing skeletal fragility as determined by the treatingclinician.
Untreated symptomatic known brain metastasis.
Serious active infection.
Too physically active (i.e. >210 minutes/week of moderate-to-vigorous intentionalexercise) or engaging in intense exercise training comparable to the RADICESexercise program.
Severe neurologic or cardiac impairment according to the American College of SportsMedicine criteria.
Uncontrolled severe respiratory insufficiency as determined by the treatingclinician or if the patient is dependent on oxygen suppletion in rest or duringexercise.
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 togive informed consent, as determined by the treating clinician.
Pregnancy.
Study Design
Study Description
Connect with a study center
Amsterdam UMC
Amsterdam, Noord-Holland 1081HV
NetherlandsActive - Recruiting
Reinier de Graaf
Delft,
NetherlandsActive - Recruiting
HagaZiekenhuis
Den Haag,
NetherlandsSite Not Available
Catharina Ziekenhuis
Eindhoven,
NetherlandsSite Not Available
Spaarne Gasthuis
Hoofddorp,
NetherlandsSite Not Available
Medisch Centrum Leeuwarden
Leeuwarden,
NetherlandsSite Not Available
Leiden Universitair Medisch Centrum
Leiden,
NetherlandsSite Not Available
Canisius Wilhelmina Ziekenhuis
Nijmegen,
NetherlandsActive - Recruiting
Laurentius Ziekenhuis
Roermond,
NetherlandsActive - Recruiting
Bravis Ziekenhuis
Roosendaal,
NetherlandsSite Not Available
Ikazia Ziekenhuis
Rotterdam,
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3508GA
NetherlandsActive - Recruiting
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