Cancer Anorexia and the Central Nervous System

Cancer Cachexia Clinical Trial

Official title:

Neuroimaging of Hypothalamic Activity During Cancer Anorexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564693
• Other study ID #: FRFLAV
• Status: Completed
• Phase: N/A
• First received: March 14, 2012
• Last updated: July 28, 2015
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

After approval of the study protocol by the Ethical Committee of our Institution (Azienda Policlinico Umberto I, Sapienza University, Rome, Italy), 9 anorexic cancer patients, 4 non-anorexic cancer patients and 2 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anorexia
• Cancer Cachexia

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine, Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No