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NCT Number: NCT05257135

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Régional du cancer de Montpellier

Montpellier, 34298, France

Location status: Recruiting

Location contact

Pierre Senesse, M.D

CONTACT

[email protected]

4 67 61 85 54 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old,
  • 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,
  • Patient requiring treatment for colon cancer (chemotherapy, targeted therapy, etc.),
  • Patient having accepted the constraints of the research and the blood samples planned for the research
  • Patient affiliated to Social Protection system
  • Informed consent form signed

Exclusion criteria

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

Treatment and study plan

Biological collection

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

Primary outcomes

  1. Number of clinical risk factors for colorectal cancer

    Time frame: Until the study completion : 6 years

  2. Number of biological risk factors for colorectal cancer

    Time frame: Until the study completion : 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore Moussion

CONTACT

[email protected]

4 67 61 24 46 ext. +33

Jean-Pierre Bleuse, MD

CONTACT

[email protected]

4 67 61 31 02 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: BCBCachexie

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Feb 25, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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