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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier:
First received: May 4, 2012
Last updated: November 18, 2014
Last verified: November 2014

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.

Condition Intervention
Colorectal Cancer
Lung Cancer
Other: blood tests and muscular biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Role of Activin A (ActA) in the Human Cancer Cachexia

Resource links provided by NLM:

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Circulating Activin A level [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary assessment measured by SNAQ score and 3-Day intake [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Body composition measured by bioimpedance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Muscle strength as measured by grip strength [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life as assessed using the QLQ-C30 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2012
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cachectic versus no cachectic patients
blood tests, muscular biopsies
Other: blood tests and muscular biopsies
blood tests and muscular biopsies


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01604642

Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT01604642     History of Changes
Other Study ID Numbers: ACTICA
Study First Received: May 4, 2012
Last Updated: November 18, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on November 20, 2014