Cancer Anorexia and the Central Nervous System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Alessandro Laviano, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01564693
First received: March 14, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The pathogenesis of cancer anorexia is complex and multifactorial. However, a number of consistent and robust evidence point to a prominent role for the central nervous system. In particular, the hyperactivation of the immune system, due to tumour growth, causes a systemic inflammatory response primarily mediated by pro-inflammatory cytokines. At the central level, inflammatory response profoundly alters the activity of the hypothalamic nuclei, which are involved in the regulation of energy homeostasis. In particular, pro-inflammatory cytokines inhibit prophagic neurons activity, while enhance the activation of the anorexigenic neurons. Although supported by compelling experimental evidence, it should be acknowledged that this pathogenic hypothesis has not been confirmed yet by human studies.

Aim of the present study is to determine the specific pattern(s) of the brain activation after assumption of a standard meal in both anorexic and non-anorexic cancer patients to reveal potential differences, which will be correlated with the levels of concurrently measured circulating pro-inflammatory cytokines. The results obtained would help in assessing the role of the central nervous system and, in particular of the hypothalamus, in the pathogenesis of cancer anorexia.


Condition
Cancer Cachexia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neuroimaging of Hypothalamic Activity During Cancer Anorexia

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE [ Time Frame: TIME 0 AND AFTER 15 AND 45 MINUTES FROM A STANDARD MEAL ASSUMPTION ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 3
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ANOREXIC CANCER PATIENTS
NON-ANOREXIC CANCER PATIENTS
CONTROL GROUP

Detailed Description:

After approval of the study protocol by the Ethical Committee of our Institution (Azienda Policlinico Umberto I, Sapienza University, Rome, Italy), 4 anorexic cancer patients, 4 non-anorexic cancer patients and 8 healthy individuals will be studied. The sample size is based on studies of neuroimaging already published and available on international journals.

Patients with confirmed cancer diagnosis will be enrolled before the initiation of any anti-cancer treatments. The presence/absence of anorexia will be investigated using a specific questionnaire (Cangiano et al., 1990) and a visual analogue scale (VAS). After an overnight fasting, blood samples will be collected from cancer patients and control subjects and interleukin(IL)-1, IL-6 and Tumor Necrosis Factor-α (TNF-α) levels will be measured by a commercially available ELISA kit.

On the same day, hypothalamic activation pattern(s) will be evaluated in patients and in control subjects by fMRI. After basal evaluation, all the groups will receive a standard oral meal, i.e., a 200 mL hypercaloric oral nutritional supplement providing 300 Kcal, and then a second fMRI scan will be performed. Using a computerized software, the average value of the grey for the hypothalamus will be calculated, and normalized for the one obtained in the basal condition, to obtain the percentage (%) of activation (or inhibition) of the hypothalamus.

Data obtained will be statistically analyzed using the t-Student and Bonferroni tests.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Lung cancer patients with confirmed cancer diagnosis before the initiation of any anti-cancer treatments will be enrolled. Four anorexic cancer patients, 4 non-anorexic cancer patients and 4 healthy individuals will be studied.

Criteria

Inclusion Criteria:

  • Lung cancer patients at diagnosis

Exclusion Criteria:

  • Patients treated with immunosuppressors, with concomitant wasting diseases (e.g. AIDS, trauma, end-stage renal disease)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564693

Locations
Italy
Department of Clinical Medicine, Sapienza University of Rome Recruiting
Rome, Italy, 00185
Contact: Alessandro Laviano, MD    +390649973902    alessandro.laviano@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Alessandro Laviano, MD Sapienza University of Rome
  More Information

No publications provided

Responsible Party: Alessandro Laviano, MD, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01564693     History of Changes
Other Study ID Numbers: FRFLAV
Study First Received: March 14, 2012
Last Updated: February 19, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
anorexia
cancer
hypothalamus
inflammation

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014