C20
Conditions
Interventions
Group 1: total neoadjuvant therapy (TNT) + trimodal prehabilitation programm
Group 2: total neoadjuvant therapy (TNT)
Sponsors
Universitätsklinikum BonnKlinik und Poliklinik für Allgemein-, Viszeral-, und Thorax- und Gefäßchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Histologically confirmed LARC without distant metastasis with intended nRCT and planned minimally invasive (robotic or laparo-scopic), continence-preserving partial or total mesorectal excision and intended adjuvant therapy after surgery • Aged 18 – 85 years • Physical and cognitive ability to perform physical exercise and participate in psycho-oncological treatment at the investigator’s discretion. • Physical and cognitive ability to handle digital sources and participate in video conferences. • The patient has given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: • Rectal cancer without intended total neoadjuvant treatment (TNT) • Stage IV rectal cancer • Current or planned therapy with antibodies or other chemotherapeutic agents except chemotherapy agents of any TNT regime • Subjects without the cognitive premises to follow psycho-oncological interventions at the investigator’s discretion • Subjects without legal capacity who are unable to understand the nature, scope, significance, and consequences of this clinical trial at the investigator’s discretion • Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial • Subjects with previous open abdominal surgeries (exception: appendectomy, cholecystectomy, hysterectomy, adnexectomy) • Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in that clinical trial • Impossibility to use video calling platforms • Known or persistent abuse of medication, drugs or alcohol at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of feasibility and compliance/adherence to an intensified trimodal prehabilitation program before surgery: •Daily diary entries, weekly patient interviews (International Physical Activity Questionnaire, IPAQ); Quality of Recovery-15 questionnaire twice a week (QoR-15) •Documentation of (missed) appointments with the psycho-oncologist, nutritional specialist, and physical trainers •Documentation of the intake of immunonutritional and synbiotic supplements in the final week before surgery •Reasons of non-fulfilment of prehabilitation measures (e.g. physical, psychological or technical) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of trimodal prehabilitation on: 1. Physical performance status: Eastern Cooperative Oncology Group Performance Status (ECOG) and Karnofsky´s-Index at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery) and visit 10 (4 ± 1 weeks after surgery); Anthropometric evaluation together with a self-reported physical activity as evaluated by the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire at visit 1 (before TNT), visit 3 (within 1 week after TNT, respectively after Restaging ), visit 4 (1 day before surgery) and visit 10 (4 ± 1 weeks after surgery); 6-minute walking distance (6 MWD) at visit 1 (before TNT), visit 3 within 1 week of restaging after TNT), visit 4 (1 day before surgery), visit 8 (POD 5) and visit 10 (4 ± 1 weeks after surgery) 2. Frailty: Clinical Frailty Scale, Grip strength: the average of three trials, measured in the subject’s dominant hand using a hand dynamometer at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery), visit 8 (POD 5) and visit 10 (4 ± 1 weeks after surgery); 30-seconds chair stand test (30 s-CST) at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery), visit 8 (POD 5) and visit 10 (4 ± 1 weeks after surgery) 3. Nutritional status: Bioelectrical impedance analysis (BIA) at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery), visit 8 (POD 5) and visit 10 (4 ± 1 weeks after surgery); Nutritional risk score (NRS) at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery) and visit 10 (4 ± 1 weeks after surgery) 4. Emotional health: Hospital Anxiety and Depression Scale (HADS) for patients at visit 1 (before TNT), visit 3 (within 1 week of restaging after TNT), visit 4 (1 day before surgery), visit 8 (POD 5) and visit 10 (4 ± 1 weeks after surgery) 5. Co | — |
Countries
Germany
Contacts
Public ContactAlexander Semaan
Universitätsklinikum BonnKlinik und Poliklinik für Allgemein-, Viszeral-, und Thorax- und Gefäßchirurgie
Outcome results
None listed