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

Colon Cancer Clinical Trial

— BCB Cachexie  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257135
• Other study ID #: PROICM 2019-15-BCA
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: May 2026

Study information

• Verified date: March 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Jean-Pierre Bleuse, MD
• Phone: 4 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2026
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Colon Cancer
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut Régional du cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (7)

Antoun S, Baracos VE, Birdsell L, Escudier B, Sawyer MB. Low body mass index and sarcopenia associated with dose-limiting toxicity of sorafenib in patients with renal cell carcinoma. Ann Oncol. 2010 Aug;21(8):1594-1598. doi: 10.1093/annonc/mdp605. Epub 20 — View Citation

Baracos VE, Reiman T, Mourtzakis M, Gioulbasanis I, Antoun S. Body composition in patients with non-small cell lung cancer: a contemporary view of cancer cachexia with the use of computed tomography image analysis. Am J Clin Nutr. 2010 Apr;91(4):1133S-113 — View Citation

Chambrier C, Sztark F; Société Francophone de nutrition clinique et métabolisme (SFNEP); Société française d'anesthésie et réanimation (SFAR). French clinical guidelines on perioperative nutrition. Update of the 1994 consensus conference on perioperative — View Citation

MacDonald AJ, Greig CA, Baracos V. The advantages and limitations of cross-sectional body composition analysis. Curr Opin Support Palliat Care. 2011 Dec;5(4):342-9. doi: 10.1097/SPC.0b013e32834c49eb. Review. — View Citation

Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Onco — View Citation

Prado CM, Baracos VE, McCargar LJ, Mourtzakis M, Mulder KE, Reiman T, Butts CA, Scarfe AG, Sawyer MB. Body composition as an independent determinant of 5-fluorouracil-based chemotherapy toxicity. Clin Cancer Res. 2007 Jun 1;13(11):3264-8. — View Citation

Prado CM, Sawyer MB, Ghosh S, Lieffers JR, Esfandiari N, Antoun S, Baracos VE. Central tenet of cancer cachexia therapy: do patients with advanced cancer have exploitable anabolic potential? Am J Clin Nutr. 2013 Oct;98(4):1012-9. doi: 10.3945/ajcn.113.060 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of clinical risk factors for colorectal cancer		Until the study completion : 6 years
Primary	Number of biological risk factors for colorectal cancer		Until the study completion : 6 years