Overview

This trial is active, not recruiting.

Conditions colorectal cancer, lung cancer
Treatment blood tests and muscular biopsies
Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Start date May 2012
End date March 2014
Trial size 80 participants
Trial identifier NCT01604642, ACTICA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Other)
blood tests, muscular biopsies
blood tests and muscular biopsies
blood tests and muscular biopsies

Primary Outcomes

Measure
Circulating Activin A level
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Role of Activin A (ActA) in the Human Cancer Cachexia
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.