Esophageal Cancer Clinical Trials

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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Incurable adenocarcinoma of the esophagus or stomach

• Recurrence after treatment with curative intent or irresectable/metastatic disease at primary diagnosis. 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 anticancer 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.

Locations
Other Locations
Netherlands
Jeroen Bosch Hospital
ACTIVE_NOT_RECRUITING
's-hertogenbosch
Flevoziekenhuis
RECRUITING
Almere Stad
Meander Medical Center
NOT_YET_RECRUITING
Amersfoort
Amsterdam UMC
RECRUITING
Amsterdam
Reinier de Graaf
RECRUITING
Delft
Catharina Ziekenhuis
RECRUITING
Eindhoven
Beatrix Hospital
RECRUITING
Gorinchem
Spaarne Gasthuis
RECRUITING
Hoofddorp
Frisius Medical Center
RECRUITING
Leeuwarden
Leiden Universitair Medisch Centrum
RECRUITING
Leiden
Sint Antonius Hospital
NOT_YET_RECRUITING
Nieuwegein
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
RadboudUMC
RECRUITING
Nijmegen
Laurentius Ziekenhuis
RECRUITING
Roermond
Bravis Ziekenhuis
RECRUITING
Roosendaal
Erasmus Medical Center
RECRUITING
Rotterdam
Ikazia Ziekenhuis
RECRUITING
Rotterdam
HagaZiekenhuis
RECRUITING
The Hague
Elisabeth Tweesteden Hospital
RECRUITING
Tilburg
Diakonessenhuis
NOT_YET_RECRUITING
Utrecht
UMC Utrecht
RECRUITING
Utrecht
Zaans Medical Center
RECRUITING
Zaandam
Contact Information
Primary
Aniek Bonhof, Msc
A.Bonhof-3@umcutrecht.nl
+31627437310
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 196
Treatments
No_intervention: Usual Care
Patients randomized to the control group will receive standard medical care, including nutritional care as provided by the center in usual care. Additionally, they receive an activity tracker (like the intervention group) but without specific instructions. We will provide the control patients with written advice on physical activity and diet according to the current guidelines (in short: to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150 min/week).
Experimental: Combined exercise and nutritional intervention.
Intervention: exercise and nutrition program group
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov