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

NCT ID: NCT01604642

Last Updated: 2018-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cachectic versus no cachectic patients

blood tests, muscular biopsies

Group Type OTHER

blood tests and muscular biopsies

Intervention Type OTHER

blood tests and muscular biopsies

Interventions

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blood tests and muscular biopsies

blood tests and muscular biopsies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 25751105 (View on PubMed)

Other Identifiers

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ACTICA

Identifier Type: -

Identifier Source: org_study_id

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