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New treatment option for GastroEsophageal Cancer
Official title The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
ClinicalTrials.gov ID: NCT06138223
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
- Utrecht, Utrecht, Netherlands
- 's-Hertogenbosch, Netherlands
- Almere Stad, Netherlands
- Amersfoort, Netherlands
- Delft, Netherlands
- Eindhoven, Netherlands
- Gorinchem, Netherlands
- Hoofddorp, Netherlands
- Leeuwarden, Netherlands
- Leiden, Netherlands
- Nieuwegein, Netherlands
- Nijmegen, Netherlands
- Roermond, Netherlands
- Roosendaal, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Tilburg, Netherlands
- Utrecht, Netherlands
- Zaandam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands; Utrecht, Utrecht, Netherlands; 's-Hertogenbosch, Netherlands; Almere Stad, Netherlands; Amersfoort, Netherlands; Delft, Netherlands and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.