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

Primary Purpose

Colorectal Cancer, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

blood tests and muscular biopsies

About this trial

This is an interventional basic science trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques Universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cachectic versus no cachectic patients

Arm Description

blood tests, muscular biopsies

Outcomes

Primary Outcome Measures

Circulating Activin A level

Secondary Outcome Measures

Dietary assessment measured by SNAQ score and 3-Day intake

Body mass index

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

Body composition measured by bioimpedance

Muscle strength as measured by grip strength

Quality of life as assessed using the QLQ-C30

Full Information

NCT ID

NCT01604642

First Posted

May 4, 2012

Last Updated

March 29, 2018

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT01604642

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

January 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Lung Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cachectic versus no cachectic patients

Arm Type

Other

Arm Description

blood tests, muscular biopsies

Intervention Type

Other

Intervention Name(s)

blood tests and muscular biopsies

Intervention Description

blood tests and muscular biopsies

Primary Outcome Measure Information:

Title

Circulating Activin A level

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Dietary assessment measured by SNAQ score and 3-Day intake

Time Frame

2 years

Title

Body mass index

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Body composition measured by bioimpedance

Time Frame

2 years

Title

Muscle strength as measured by grip strength

Time Frame

2 years

Title

Quality of life as assessed using the QLQ-C30

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Cliniques Universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

25751105

Citation

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.

Results Reference

derived

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

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