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

Last updated: July 18, 2024
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Esophageal Disorders

Treatment

Nutrition intervention

Exercise intervention

Clinical Study ID

NCT06138223
NL83835.018.23
  • Ages > 18
  • All Genders

Study 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 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

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Nutrition intervention
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
September 30, 2028

Study 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) systemic therapy for progressive disease (yes versus no) and time since failure of first line therapy (shorter or longer than 3 months ago). Due to the nature of the intervention, it is not possible to blind the patients, the local study nurses, or the investigators to the treatment assignment.

Connect with a study center

  • Amsterdam UMC

    Amsterdam, Noord-Holland 1081HV
    Netherlands

    Active - Recruiting

  • Reinier de Graaf

    Delft,
    Netherlands

    Active - Recruiting

  • HagaZiekenhuis

    Den Haag,
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp,
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwarden

    Leeuwarden,
    Netherlands

    Site Not Available

  • Leiden Universitair Medisch Centrum

    Leiden,
    Netherlands

    Site Not Available

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Laurentius Ziekenhuis

    Roermond,
    Netherlands

    Active - Recruiting

  • Bravis Ziekenhuis

    Roosendaal,
    Netherlands

    Site Not Available

  • Ikazia Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3508GA
    Netherlands

    Active - Recruiting

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