Metastatic pancreatic carcinoma (pancreatic cancer, ICD-10-GM: C25, metastases if coded separately: C78–C79) C25 C78 C79
Conditions
Interventions
Group 1: Group A: Nutritional counseling + short-term fasting (approx. 40-70 hours per chemotherapy cycle)
Group 2: Group B: Only nutritional counseling
Sponsors
Charité - Universitätsmedizin Berlin, Charité-Hochschulambulanz für Naturheilkunde im Immanuel-Krankenhaus Berlin-Wannsee
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - The study includes patients with a confirmed diagnosis of metastatic pancreatic cancer who are receiving palliative systemic chemotherapy, which is treated with at least 4 cycles of chemotherapy (FOLFIRINOX, NALIRIFOX, GEMCITABINE-ABRAXANE, GEMCITABINE monotherapy). - Life expectancy > 3 months
Exclusion criteria
Exclusion criteria: - Existing underweight (BMI 5% of body weight in the last month. - History of eating disorders (anorexia nervosa, bulimia) - Pre-existing addiction / current alcohol abuse - Serious mental illness (e.g. severe depression, schizophrenia) - Other serious internal medical conditions - Terminal or serious illness with significant impairment of mobility and overall vitality - Insulin-dependent diabetes mellitus - No email address or internet access (due to electronic CRF) - Simultaneous participation in another study - Language communication difficulties, dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood and quality of life (QoL): Functional Assessment of Cancer Therapy–General, FACT-G (PWB, SWB, EWB, FWB): Group difference in change in FACT-G from V0 to V2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters (usually from V0 to V1 and V0 to V2): - QoL: FACT-G (PWB, SWB, EWB, FWB) from V1 to V2 - Trial outcome index score (TOI=PWB+FWB+AC) - Total AC (FACT-G + AC) - Hepatobiliary subscale: FACT-Hep (Functional Assessment of Cancer Therapy – Liver Function Questionnaire) - Fatigue: FACIT-F - Anxiety and depression: Hospital Anxiety and Depression Scale: HADS - Symptom burden: German version of the Edmonton Symptom Assessment System (ESAS) - Incidence and severity of side effects: Likert scales and elective items from the Common Terminology Criteria for Adverse Events (CTCAE) (CTCAE as a medical assessment on the day of CTx) - Weight, BMI - Grip strength measurement, Timed Up & Go TEST (TUG) (physical capacity) - Body composition: Bioimpedance analysis (BIA measurement) - Group difference in change in Eastern Cooperative Oncology Group (ECOG) status from V0 to V2 As well as: - Progression-free survival (PFS), overall survival (OAS) and mortality are recorded for time points V1 - V5 (V3 = 12 months after study start, V4 = 24 months after study start, V5 = 36 months after study start) with and without adjustment (according to patient-reported outcomes at time point V0). As part of the follow-up examinations (=V3, V4, V5), quality of life, prevalence and severity of CTx-induced long-term side effects are also recorded. The survey will be conducted via anamnestic questioning about specific complaints and, if necessary, will include existing medical reports and findings as well as additional sources of information such as treating physicians, relatives specified by the subjects and death registers. - The planned CTx dose is recorded a priori, dose changes and the respective time are recorded for each CTx in order to be able to calculate the cumulative dose retrospectively. - Routine clinical laboratory tests consisting of differential blood count, CRP, albumin, liver values (GPT, GOT, y-GT, AP), kidn | — |
Countries
Germany
Contacts
Public ContactDaniela Koppold
Charité - Universitätsmedizin Berlin, Charité-Hochschulambulanz für Naturheilkunde im Immanuel-Krankenhaus Berlin-Wannsee
Outcome results
None listed