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RECRUITING

NCT06138223

The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

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 steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed. However, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment. A total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2024-01-01

Completion Date

2028-09-30

Last Updated

2024-07-22

Healthy Volunteers

Conditions

GastroEsophageal Cancer Incurable Disease

Interventions

OTHER

Exercise intervention

During 12 weeks, patients will visit twice a week a trained oncology physiotherapist for one hour per session. This training includes supervised aerobic and resistance exercises to increase aerobic condition and muscle resistance, based on their own fitness level as assessed at baseline. Additionally, physiotherapists will educate participants on how to increase their daily activity. To this end, all participants will receive an activity tracker to monitor their daily activities.

OTHER

Nutrition intervention

Once every two weeks patients in the intervention group will receive a nutritional assessment and intervention by a trained dietician for optimization of their nutritional intake to improve their nutritional status, following the ESPEN guideline on nutrition in cancer patients and the national guidelines of the National Nutritionists Oncology Working Group (NNOWG; in Dutch: Landelijke Werkgroep Diëtisten Oncologie, LWDO). Moreover, an amount of 15-25 grams of protein within 1-2 hours after exercise will be advised, to prevent muscle protein breakdown and enhance muscle protein synthesis.

Inclusion Criteria: * 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 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.

Locations (12)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Reinier de Graaf

Delft, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Spaarne Gasthuis

Hoofddorp, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Leiden Universitair Medisch Centrum

Leiden, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Laurentius Ziekenhuis

Roermond, Netherlands

Bravis Ziekenhuis

Roosendaal, Netherlands

Ikazia Ziekenhuis

Rotterdam, Netherlands

HagaZiekenhuis

The Hague, Netherlands

UMC Utrecht

Utrecht, Netherlands