Trial Information

Neuroimaging of Hypothalamic Activity During Cancer Anorexia

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.