Role of Activin A (ActA) in the Human Cancer Cachexia

Colorectal Cancer Clinical Trial

Official title:

Role of Activin A (ActA) in the Human Cancer Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604642
• Other study ID #: ACTICA
• Status: Completed
• Phase: N/A
• First received: May 4, 2012
• Last updated: March 29, 2018
• Start date: May 2012
• Est. completion date: January 1, 2016

Study information

• Verified date: March 2018
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18-year-old or older

• Colorectal or lung cancer demonstrated by histology or cytology

• New diagnosis or new recurrence

• Expected survival more than 3 months

• No previous history of other cancer in the last 5 years

• No pregnancy or lactation

• Signed informed consent

Exclusion Criteria:

• Non-caucasian

• Major digestive malabsorption

• Major depression

• Artificial nutrition

• Height doses of steroids (>1 mg/kg hydrocortisone equivalent)

• Hyperthyroidism

• Other causes of malnutrition

• Expected survival less than 3 months

• Severely impaired walking

• Anticoagulants or antiplatelet therapy

• Disability or medical condition which might prevent the compliance to the protocol

• Any conditions which may prevent the compliance to the protocol

• Performance status ECOG > ou = 4

• Participation to other clinical studies

Related Conditions & MeSH terms

• Cachexia
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer

Intervention

Other:
• blood tests and muscular biopsies
blood tests and muscular biopsies

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating Activin A level		2 years
Secondary	Dietary assessment measured by SNAQ score and 3-Day intake		2 years
Secondary	Body mass index		2 years
Secondary	Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference		2 years
Secondary	Body composition measured by bioimpedance		2 years
Secondary	Muscle strength as measured by grip strength		2 years
Secondary	Quality of life as assessed using the QLQ-C30		2 years