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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Nov 16, 2023

Keywords

ClinConnect Summary

The RADICES trial is studying how a combination of exercise and nutrition can improve the quality of life for patients with incurable cancer of the esophagus and stomach. While traditional treatments can help patients live longer, many experience a decrease in their quality of life over time due to factors like loss of muscle mass and poor nutrition. This study aims to see if helping patients become more physically active and eat better can make a positive difference in how they feel.

To be eligible for the trial, participants must be at least 18 years old, have incurable adenocarcinoma of the esophagus or stomach, and have experienced disease progression after their first treatment. They should also be willing to follow the exercise and nutrition program, which includes wearing an activity tracker and completing questionnaires about their health. The study will compare the usual care that patients receive with the added benefits of this exercise and nutrition plan. Participants can expect support in improving their physical health, and the trial is currently recruiting patients who meet these criteria.

Gender

ALL

Eligibility criteria

• 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.