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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Lung Cancer
• Intervention / Treatment: Other: blood tests and muscular biopsies

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cachectic versus no cachectic patients; blood tests, muscular biopsies	Other: blood tests and muscular biopsies; blood tests and muscular biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Circulating Activin A level	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Body mass index	2 years
Dietary assessment measured by SNAQ score and 3-Day intake	2 years
Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference	2 years
Body composition measured by bioimpedance	2 years
Muscle strength as measured by grip strength	2 years
Quality of life as assessed using the QLQ-C30	2 years

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

General Publications

• Loumaye A, de Barsy M, Nachit M, Lause P, Frateur L, van Maanen A, Trefois P, Gruson D, Thissen JP. Role of Activin A and myostatin in human cancer cachexia. J Clin Endocrinol Metab. 2015 May;100(5):2030-8. doi: 10.1210/jc.2014-4318. Epub 2015 Mar 9.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 24, 2012

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Emaciation; Weight Loss; Cachexia
• Other Study ID Numbers: ACTICA