Role of Activin A (ActA) in the Human Cancer Cachexia
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started May 2012
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedApril 2, 2018
March 1, 2018
1.8 years
May 4, 2012
March 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Circulating Activin A level
2 years
Secondary Outcomes (6)
Dietary assessment measured by SNAQ score and 3-Day intake
2 years
Body mass index
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
- +1 more secondary outcomes
Study Arms (1)
cachectic versus no cachectic patients
OTHERblood tests, muscular biopsies
Interventions
blood tests and muscular biopsies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Related Publications (1)
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.
PMID: 25751105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 24, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2014
Study Completion
January 1, 2016
Last Updated
April 2, 2018
Record last verified: 2018-03