Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Laviano, MD | University of Roma La Sapienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Medicine, Sapienza University of Rome | Rome | Italy | 00185 | Italy |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ANOREXIC CANCER PATIENTS | We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools. |
| FG001 | NON-ANOREXIC CANCER PATIENTS | According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools. |
| FG002 | CONTROL GROUP | Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ANOREXIC CANCER PATIENTS | Based on the anorexia instruments that we used, we considered these patients as anorexic. |
| BG001 | NON-ANOREXIC CANCER PATIENTS | Based on the anorexia instruments that we used, we considered these patients as non-anorexic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | BOLD | TIME 0 (BASELINE) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANOREXIC CANCER PATIENTS | Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PROF. ALESSANDRO LAVIANO | SAPIENZA UNIVERSITY OF ROME | +390649973902 | alessandro.laviano@uniroma1.it |
Not provided
| ID | Term |
|---|---|
| D000855 | Anorexia |
| D009369 | Neoplasms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
serum
| BG002 | CONTROL GROUP | These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | CONTROL GROUP | Healthy subjects were studied regarding BOLD signal activity by fMRI |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | NON-ANOREXIC CANCER PATIENTS | Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated. | 0 | 4 | 0 | 4 |
| EG002 | CONTROL GROUP | Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated. | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided