Impact of exercise and diet on quality of life for patients with incurable esophageal and stomach cancer

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

Not applicable Interventional Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06138223

This study is testing if a program that combines exercise and better nutrition can improve the quality of life for patients with incurable esophageal and stomach cancer after their first treatment hasn't worked.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment196 (estimated)
Ages18 Years and up
SexAll
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other
Drugs / interventionsnivolumab
Locations22 sites (Amsterdam, North Holland and 21 other locations)
Trial IDNCT06138223 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a combined exercise and nutritional intervention on the quality of life of patients suffering from incurable gastroesophageal adenocarcinoma after failing first-line treatment. Patients will be randomized to receive either the intervention or usual care, with stratification based on various clinical factors. The goal is to determine if improving physical capacity and nutritional status can enhance the overall quality of life for these patients. The study will carefully evaluate both the benefits and potential harms of the interventions.

Who should consider this trial

Good fit: Ideal candidates are patients with incurable adenocarcinoma of the esophagus or stomach who have experienced disease progression after first-line treatment.

Not a fit: Patients who are not able or willing to participate in the exercise and nutritional program may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients with incurable gastroesophageal cancer.

How similar studies have performed: Other studies have shown promising results with similar exercise and nutritional interventions in cancer patients, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

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.

  * Note:

After one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence/progression of GAC after curative treatment or irresectable/metastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.

The inclusion criterium before broadening was:

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.

Where this trial is running

Amsterdam, North Holland and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions GastroEsophageal CancerIncurable Diseasegastroesophageal cancerGACPalliativeexercise interventionnutritional interventionQuality of life
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.