C15-C26
Conditions
Interventions
Group 1: Observational study: Step counters and movement diaries are used to document the current activity in everyday life (e.g. going for a walk, housework, etc.) over two weeks before the regularly
Sponsors
Klinik und Poliklinik für Innere Medizin I
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age> 18 at the time of signing the consent form - declaration of consent signed by the patient - suitable for fulfilling the requirements of the Study protocol in the opinion of the investigator - Histologically confirmed gastro-oncological tumor diagnosis (squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagogastric junction and gastric cancer, colorectal cancer, pancreatic cancer, cholangiocellular carcinoma, hepatocellular carcinoma) - sufficient knowledge of the German language
Exclusion criteria
Exclusion criteria: - significant cardiovascular disease such as heart failure Class II or higher according to the New York Heart Association classification, myocardial infarction or cerebral insult within 6 months prior to the randomization, cardiac unstable despite anti-arrhythmic therapy, arrhythmia> Grade 2 NCI CTCAE or unstable angina pectoris. - serious psychiatric, pulmonary, orthopedic or neurological illness - patients with a malignancy other than gastrointestinal tumor disease with the exception of patients who were disease-free at least five years prior tandomization and with the exception from patients with an adequate-treated and completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ cervical, breast or prostate cancer as well as stage I uterine carcinoma - simultaneous participation in another clinical study while participating in this clinical study - possible dependence of the patient on the investigator, including spouse, children and close relatives of each investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue (multidimensional Fatgiue Inventory MFI-20) three times each as part of the staging exams | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life (EORTC QLQ-C30), sarcopenia (BMI; sarcopenia measurement in the regularly planned staging CT without additional imaging), neutropenia, anemia, thrombocytopenia, tumor markers, GCSF administration, postponement of chemotherapy in the last three months, dose reduction of chemotherapy in the last three months, type, frequency and severity of adverse events according to NCI CTCAE v5.0 (nausea, vomiting, pain, polyneuropathy, quality of sleep, constipation), overall survival, objective response rate of the palliative intervention or chemotherapy (ORR), complete response rate of the palliative intervention or chemotherapy (CRR), disease control rate of the palliative intervention or chemotherapy (DCR), time to tumor progression under palliative intervention or chemotherapy (TIP), progression-free survival under palliative intervention or chemotherapy (PFS) | — |
Countries
Germany
Contacts
Public ContactSophie Schlosser
Klinik und Poliklinik für Innere Medizin I
Outcome results
None listed