Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary — Treatable  

Rectal Cancer Clinical Trial

Official title: Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine

Status Not yet recruiting

Clinical Trial Summary

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.

Clinical Trial Description

Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).

Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment. ;

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Rectal Cancer
• Rectal Neoplasms

• NCT number: NCT06274190
• Study type: Interventional
• Source: KU Leuven
• Contact: Inge Geraerts, PhD
• Phone: +3216329120
• Email: inge.geraerts@kuleuven.be
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Completion date: March 2026