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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Recruiting
• UMC Utrecht
  Utrecht, Utrecht, Netherlands Recruiting
• Flevoziekenhuis
  Almere Stad, Netherlands Recruiting
• Reinier de Graaf
  Delft, Netherlands Recruiting
• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• Beatrix Hospital
  Gorinchem, Netherlands Recruiting

Study contacts

• Principal investigator: Hanneke van Laarhoven — Amsterdam AMC
• Study coordinator: Aniek Bonhof, Msc
• Email: A.Bonhof-3@umcutrecht.nl
• Phone: +31627437310

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MGC030 in adults with advanced solid tumors

  This trial tests MGC030 in adults with advanced urothelial, gastric/GEJ, esophageal, colorectal, gastric, pancreatic, or GEJ cancers to see if it is safe and whether it can shrink tumors or stop growth.

  Recruiting Phase 1 MacroGenics · Lake Success, New York · NCT07822399

• First-in-human dose study of DA-3501 for CLDN18.2-positive stomach, GEJ cancer, and pancreatic cancer

  A first-in-human study tests DA-3501 in adults with CLDN18.2-positive advanced stomach/GEJ cancer or pancreatic cancer to find a safe, effective dose.

  Recruiting at 3 sites Phase 1 Dong-A ST Co., Ltd. · Seongnam, Bundang and 2 other locations · NCT07481357

• Collecting blood and leftover tumor tissue to test molecular residual disease (MRD) detection

  This project will test whether blood and leftover tumor tissue from adults with certain solid tumors can be used with Natera's MRD blood tests to find tiny amounts of cancer (ctDNA) after treatment.

  Recruiting Natera, Inc. · Austin, Texas · NCT07318051

• Pulsed low-dose-rate radiation plus chemotherapy versus standard chemoradiation for esophageal cancer

  This trial will test whether delivering radiation as pulsed low-dose-rate together with chemotherapy reduces serious esophagitis compared with standard chemoradiation in adults with locally advanced esophageal adenocarcinoma.

  Recruiting Phase 2 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT06906887

• Evaluating zanidatamab for HER2-expressing tumors

  This study is testing a new drug called zanidatamab to see if it can help people with certain types of cancer that have high levels of HER2 and who have already tried other treatments without success.

  Recruiting at 30 sites Phase 2 Jazz Pharmaceuticals · Prescott, Arizona and 41 other locations · NCT06695845

• Support program for patients with gastroesophageal cancer

  This study tests if a special support program with nutrition help can improve the health of patients with gastroesophageal cancer compared to regular care during their treatment.

  Recruiting at 2 sites H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida and 1 other locations · NCT06497569

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.