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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604642
First Posted: May 24, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  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: None (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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604642


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01604642     History of Changes
Other Study ID Numbers: ACTICA
First Submitted: May 4, 2012
First Posted: May 24, 2012
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Cachexia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms