A Clinico-biological Database in Cachexia in Patients With Colon Cancer

Not Applicable

Recruiting

• Conditions: Colon Cancer
• Interventions: Biological: Biological collection

• Registration Number: NCT05257135
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

Creation of a prospective clinico-biological database dedicated to cachexia and undernutrition in order to carry out future research projects, to improve our knowledge of colon cancer and cachexia and to optimize the therapeutic management of patients

Detailed Description

Patients with cancers, and in particular colorectal cancers, very often present profound nutritional and/or metabolic alterations, the most spectacular being cachexia. Cachexia is a morbid syndrome characterized by rapid involuntary weight loss mainly affecting the storage tissues of adipose tissue and skeletal muscle. This global metabolic syndrome is a major contributory factor and sometimes causative factor in the failure of treatments and the death of patients. Although a major public health problem, this disease is poorly understood and for which there are no reliable biomarkers and no universally accepted treatment protocol. It therefore appears essential to better understand this disease in order to improve the well-being and survival of patients. Being a disease with a strong metabolic component, the integration of nutritional approaches is essential. Many advances have been made in recent years in the field of clinical nutrition, particularly in cancer cachexia. Clinical nutrition is a new, transversal, booming specialty.

Recent publications suggests that cancer patients, overweight or obese, may present muscle depletion, an independent predictor of overall survival. Recent results suggest that muscle atrophy is associated with more severe toxicity of anti-cancer treatments such as fluoropyrimidines, anthracyclines, combination chemotherapy, sunitinib and sorafenib. Muscle wasting is a predictive factor for therapeutic dose limitation: dose reduction, delay or definitive discontinuation of treatment. The majority of anti-cancer drugs have a limited therapeutic index. It is important to determine the factors that explain the individual variations in efficacy and toxicity, and the determination of body composition for each patient is therefore an important step in the nutritional evaluation process, and essential data for this data base.

The investigators therefore propose the development of a prospective clinico-biological database for cachexia in patients with colon cancer, can be used for research projects aimed at developing tailored patient management strategies.

Study Timeline

• Study Start: 2021-12-23
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age ≥ 18 years old,
2. Patient treated at the Montpellier Regional Cancer Institute for colon cancer not eligible for surgery (of the primary tumor or associated metastases), whether undergoing treatment or not,
3. Patient requiring treatment for colon cancer (chemotherapy, targeted therapy, etc.),
4. Patient having accepted the constraints of the research and the blood samples planned for the research
5. Patient affiliated to Social Protection system
6. Informed consent form signed

Exclusion Criteria

1. Patient requiring surgery (for treatment of colon cancer or metastasis)
2. Patient with exclusive peritoneal carcinomatosis
3. Patient requiring radiotherapy
4. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
5. Pregnant and/ or breastfeeding women
6. Patient cared for an emergency context

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological collection	Biological collection	For all patients included in the study: * Blood samples collected at different times: at inclusion and during treatment every 6 months * In parallel to this biological collection, standardized clinical data will be entered into a database

Primary Outcome Measures

Name	Time	Method
Number of clinical risk factors for colorectal cancer	Until the study completion : 6 years
Number of biological risk factors for colorectal cancer	Until the study completion : 6 years

Trial Locations

Locations (1)

Institut Régional du cancer de Montpellier; 🇫🇷 Montpellier, France