Status:
RECRUITING
The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
UMC Utrecht
Conditions:
GastroEsophageal Cancer
Incurable Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group...
Detailed Description
Randomization will be stratified based on: duration of first line therapy (shorter or longer than 6 months), WHO performance status (0, 1 versus 2), (intended) start of second-line (or further) system...
Eligibility Criteria
Inclusion
- Incurable adenocarcinoma of the esophagus or stomach.
- Progressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric/esophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with second/third/etc. line therapy are eligible for inclusion too)
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06138223
Start Date
January 1 2024
End Date
September 30 2028
Last Update
July 22 2024
Active Locations (12)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1081HV
2
Reinier de Graaf
Delft, Netherlands
3
Catharina Ziekenhuis
Eindhoven, Netherlands
4
Spaarne Gasthuis
Hoofddorp, Netherlands