RecruitingNot ApplicableNCT06138223

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)

Enrollment

196 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured exercise and diet program can improve quality of life in people with incurable adenocarcinoma of the esophagus or stomach. Patients in this group often experience weakness and poor nutrition, and researchers want to know if lifestyle support can make a difference. **You may be eligible if...** - You have incurable (non-curable) adenocarcinoma of the esophagus or stomach - Your cancer has progressed after first-line palliative treatment, OR you are within 6 months after completing certain curative treatments that did not work - You are capable of participating in an exercise and diet program **You may NOT be eligible if...** - You have a cancer type other than adenocarcinoma of the esophagus or stomach - You are not within the specified treatment history window - You are physically unable to participate in exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise 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.

OTHERNutrition 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.


Locations(22)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Meander Medical Center

Amersfoort, Netherlands

Reinier de Graaf

Delft, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Beatrix Hospital

Gorinchem, Netherlands

Spaarne Gasthuis

Hoofddorp, Netherlands

Frisius Medical Center

Leeuwarden, Netherlands

Leiden Universitair Medisch Centrum

Leiden, Netherlands

Sint Antonius Hospital

Nieuwegein, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RadboudUMC

Nijmegen, Netherlands

Laurentius Ziekenhuis

Roermond, Netherlands

Bravis Ziekenhuis

Roosendaal, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Ikazia Ziekenhuis

Rotterdam, Netherlands

HagaZiekenhuis

The Hague, Netherlands

Elisabeth Tweesteden Hospital

Tilburg, Netherlands

Diakonessenhuis

Utrecht, Netherlands

Zaans Medical Center

Zaandam, Netherlands

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NCT06138223


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