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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01604642
First received: May 4, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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
Estimated Primary Completion Date: May 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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604642

Contacts
Contact: Jean-Paul Thissen, M.D, PhD 003227645469 jeanpaul.thissen@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Jean-Paul Thissen, MD, PhD    003227645469    jeanpaul.thissen@uclouvain.be   
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
ClinicalTrials.gov Identifier: NCT01604642     History of Changes
Other Study ID Numbers: ACTICA
Study First Received: May 4, 2012
Last Updated: May 23, 2012
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
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014