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CompletedNCT01604642Updated Apr 2, 2018

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

An interventional study of blood tests and muscular biopsies in Colorectal Cancer and Lung Cancer, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-02.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Cancer
  • Lung Cancer

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03

In context

Cachexia

328 studies on the registry are indexed under Cachexia; 73 are open to participants now.

This study's enrollment of 150 is above the median of 63 across 219 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Other
    cachectic versus no cachectic patients

    blood tests, muscular biopsies

    Other: blood tests and muscular biopsies

Interventions

  • Otherblood tests and muscular biopsies

    blood tests and muscular biopsies

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What researchers measure

Primary outcomes

  1. Circulating Activin A level

    Time frame: 2 years

Secondary outcomes

  1. Dietary assessment measured by SNAQ score and 3-Day intake

    Time frame: 2 years

  2. Body mass index

    Time frame: 2 years

  3. Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference

    Time frame: 2 years

  4. Body composition measured by bioimpedance

    Time frame: 2 years

  5. Muscle strength as measured by grip strength

    Time frame: 2 years

  6. Quality of life as assessed using the QLQ-C30

    Time frame: 2 years

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Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
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References and documents

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. PubMed 25751105 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01604642
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
May 24, 2012
Start date
May 2012
Primary completion
Mar 2014
Completion
Jan 1, 2016
Last update
Apr 2, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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