Colorectal carcinoma (bowel cancer, ICD-10-GM: C18–C20)
Conditions
Interventions
Group 1: Group A: Nutritional counseling + short-term fasting (approx. 45-70 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 75 Years
Inclusion criteria
Inclusion criteria: The study will include patients with a confirmed diagnosis of stage II colorectal cancer with high-risk factors or stage III colorectal cancer who are receiving adjuvant systemic chemotherapy with FOLFOX or CAPOX for at least 4 cycles.
Exclusion criteria
Exclusion criteria: - Existing underweight (BMI 5% of body weight in the last month. - History of eating disorders (anorexia nervosa, bulimia) - Known addiction / existing 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) also from V1 to V2 - Trial outcome index score (TOI=PWB+FWB+AC) - Total AC (FACT-G + AC) - Subscale colorectal cancer: FACT-C - 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), disease-free survival (DFS), overall survival (OAS), and mortality will be assessed once a year for 5 years (V1 - V7) with and without adjustment (based on patient-reported outcomes at time V0). Quality of life, prevalence, and severity of CTx-induced long-term side effects are also recorded during these follow-up examinations. The survey is to be conducted via anamnestic questioning about specific complaints and, if necessary, include existing medical reports and findings as well as additional sources of information such as treating physicians, relatives specified by test subjects, and death registers. - The planned CTx dose is recorded a priori, and dose changes and the respective time are recorded for each CTx so that the cumulative dose can be calculated retrospectively. - Gut microbiome/stool samples (V0 to V2) to examine microbiome changes during chemotherapy. - Routine clinical laboratory tests consisting of differential blood count, liver values (GPT, GOT, y-GT, AP), kidney function (creatinine, urea) every 2-3 weeks, and tumor markers (CEA) | — |
Countries
Germany
Contacts
Public ContactDaniela Koppold
Charité - Universitätsmedizin Berlin, Charité-Hochschulambulanz für Naturheilkunde im Immanuel-Krankenhaus Berlin-Wannsee
Outcome results
None listed