Skip to content

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

Development of a Prospective Clinico-biological Database in Cachexia in Patients With Colon Cancer

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05257135
Acronym
BCBCachexie
Enrollment
150
Registered
2022-02-25
Start date
2021-12-23
Completion date
2029-05-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

BIOLOGICALBiological collection

\- Blood samples collected at different times: at inclusion and during treatment ( every 6 month)

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of clinical risk factors for colorectal cancerUntil the study completion : 6 years
Number of biological risk factors for colorectal cancerUntil the study completion : 6 years

Countries

France

Contacts

Primary ContactJean-Pierre Bleuse, MD
DRCI-icm105@icm.unicancer.fr4 67 61 31 02
Backup ContactAurore Moussion
DRCI-icm105@icm.unicancer.fr4 67 61 24 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026