The effect of exeRcise And Diet on quality of life in patients with Incurable Cancer of Esophagus and Stomach

Recruiting

• Conditions: cancer of the upper GI tract; gastroesophageal cancer; 10017991

• Registration Number: NL-OMON56382
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 196

Inclusion Criteria

• Incurable adenocarcinoma of the esophagus or stomach.
• 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. 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 second/third/etc. line 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life.</p><br>