Trial Outcomes & Findings for Cancer Anorexia and the Central Nervous System (NCT NCT01564693)
NCT ID: NCT01564693
Last Updated: 2015-08-18
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
TIME 0 (BASELINE)
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
CONTROL GROUP
Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
2
|
|
Overall Study
COMPLETED
|
9
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cancer Anorexia and the Central Nervous System
Baseline characteristics by cohort
| Measure |
ANOREXIC CANCER PATIENTS
n=9 Participants
Based on the anorexia instruments that we used, we considered these patients as anorexic.
|
NON-ANOREXIC CANCER PATIENTS
n=4 Participants
Based on the anorexia instruments that we used, we considered these patients as non-anorexic
|
CONTROL GROUP
n=2 Participants
These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
76.25 years
STANDARD_DEVIATION 6.95 • n=7 Participants
|
65 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
71.66 years
STANDARD_DEVIATION 8.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: TIME 0 (BASELINE)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).
Outcome measures
| Measure |
ANOREXIC CANCER PATIENTS
n=9 Participants
Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
|
NON-ANOREXIC CANCER PATIENTS
n=4 Participants
Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
|
CONTROL GROUP
n=2 Participants
Healthy subjects were studied regarding BOLD signal activity by fMRI
|
|---|---|---|---|
|
ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE
|
585.57 BOLD
Standard Deviation 55.69
|
667.92 BOLD
Standard Deviation 33.18
|
511.22 BOLD
Standard Deviation 79.43
|
Adverse Events
ANOREXIC CANCER PATIENTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NON-ANOREXIC CANCER PATIENTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place