Feasibility, Compliance, and Immune Response to an Intensified Trimodal Prehabilitation Program during Neoadjuvant Treatment before Rectal Cancer Surgery (PreReC-Study)

Not Applicable

• Conditions: C20; Malignant neoplasm of rectum

• Registration Number: DRKS00030170
• Lead Sponsor: niversitätsklinikum BonnKlinik und Poliklinik für Allgemein-, Viszeral-, und Thorax- und Gefäßchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically confirmed LARC without distant metastasis with in-tended 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 par-ticipate in psycho-oncological treatment at the investigator’s discre-tion.
• Physical and cognitive ability to handle digital sources and partici-pate in video conferences.

• The patient has given written informed consent to participate in the study.

Exclusion Criteria

• Rectal cancer without intended neoadjuvant or adjuvant treatment

• Rectal Cancer with the indication for total neoadjuvant therapy ac-cording RAPIDO or OPRA-Study
o Threatened sphincter preserving rectal resection due to tu-mor localisation and/or size
o Involvement of mesorectal fascia, circumferential resection margin at risk, cT4b carcinoma, levatores threatened, lat-eral lymph nodes involved

• Stage IV rectal cancer

• Current or planned therapy with antibodies or other chemothera-peutic agents except Capecitabine/5-FU and/or Oxaliplatin

• 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 inves-tigator’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: ap-pendectomy, 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 zoom

• Known or persistent abuse of medication, drugs or alcohol at the investigator’s discretion

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of feasibility and compliance to an intensified trimodal prehabilitation program during 14 - 18 weeks before reactal cancer surgery:<br><br>• Daily diary entries (Quality of Recovery-15 questionnaire (QoR-15)), weekly patient interviews by International Physical Activity Questionnaire (IPAQ)<br><br>• Documentation of adherence to appointments with psycho-oncologist, nutritional specialist and fitness coach<br><br>• Documentation of the intake of <br>immunonutritional and synbiotic supplements during the last week before surgery<br><br>• Documentation of reasons of non-fulfilment of prehabilitation measures (e.g. physical, mental or technical)