Cancer Anorexia and the Central Nervous System

NCT01564693 | Completed Results DMC

• 1 other identifier: FRFLAV
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Cachexia

Keywords

anorexia; cancer; hypothalamus; inflammation

Outcome Measures

Primary Outcomes (1)

• ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE

  We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).

  TIME 0 (BASELINE)

Study Arms (3)

ANOREXIC CANCER PATIENTS

Nine lung cancer patients were diagnosed as anorexic based on the results obtained by the appetite assessment tools we used. These patients were studied by fMRI regarding the hypothalamic activity.

NON-ANOREXIC CANCER PATIENTS

Four lung cancer patients were diagnosed as non-anorexic based on the results obtained by the appetite assessment tools we used. These patients were studied by fMRI regarding the hypothalamic activity.

CONTROL GROUP

Two healthy volunteers with normal appetite were studied by fMRI regarding the hypothalamic activity.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lung cancer patients with confirmed cancer diagnosis before the initiation of any anti-cancer treatments will be enrolled. Nine anorexic cancer patients, 4 non-anorexic cancer patients and 2 healthy individuals will be studied.

You may qualify if:

• Lung cancer patients at diagnosis

You may not qualify if:

• Patients treated with immunosuppressors, with concomitant wasting diseases (e.g. AIDS, trauma, end-stage renal disease)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Clinical Medicine, Sapienza University of Rome

Rome, Italy, 00185, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Anorexia; Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: PROF. ALESSANDRO LAVIANO
• Organization: SAPIENZA UNIVERSITY OF ROME

alessandro.laviano@uniroma1.it

+390649973902

Study Officials

• Alessandro Laviano, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: August 18, 2015
• Results First Posted: July 9, 2015

Record last verified: 2015-07

Locations

IT (1)