- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493740
Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls (Cephalic chemo)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Food stimulation of gastric and pancreatic secretion is classically divided into cephalic, gastric and intestinal phases.
Cephalic phase refers to a simultaneous activation of gastrointestinal motility, gastric acid and pancreatic enzyme secretion ,as well as, release of hormones from the endocrine pancreas which occurs through activation of vagal -efferents as a result of food-related sensory stimuli such as taste and smell prior to nutrient absorption and which coincides with a thermogenic response.
Of the cephalic phase secretions, cephalic phase insulin release (CPIR) has received the most attention, but pancreatic polypeptide (PP) and glucagon responses have also been studied. While the magnitude of cephalic phase insulin release is relatively small (25% above baseline), pancreatic polypeptide increases 100% above baseline. The large magnitude of the PP response makes it a sensitive indicator of vagal activation to food stimuli.
In most experiments, subjects are either exposed to visual and olfactory stimulation by seeing and smelling the food stimulus or are required to perform a modified sham-feed, i.e. to taste, chew and then expectorate the food stimulus.
In general, cephalic phase are thought to be preparatory responses before ingestion of food. Because of their small magnitude, the physiological significance of the cephalic phase hormonal responses has been largely discounted. However, there is evidence that experimental prevention of CPIR lead to hyperinsulinemia and hyperglycemia. Therefore, CPIR may contribute to glucose homeostasis /regulation. Moreover CPIR may be an indicator of hunger and could be important for understanding eating disorders.
In parallel with these hormonal secretion ,an increase in energy expenditure has been also observed .This thermogenic response to food is even greater with sham feeding than with normal feeding and is paralleled by changes in RQ showing enhanced carbohydrate oxidation.
Disorders of taste are prevalent symptom in patients undergoing chemotherapy. The literature suggests that 36% to71% of patients report a distressing change in taste which often have a negative impact on quality of life and nutrition. It is unknown whether the cephalic phase of oncology patients may also be disturbed.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nachum Vaisman, Prof.
- Phone Number: +972-524-266-596
- Email: vaisman@tasmc.health.gov.il
Study Locations
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-
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Tel Aviv, Israel
- Recruiting
- Tel Aviv Sourasky Medical Center
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Contact:
- Nachum Vaisman, Prof.
- Phone Number: +972-524-266596
- Email: vaisman@tasmc.health.gov.il
-
Principal Investigator:
- Nachum Vaisman, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Subjects:
40 oncology patients of the following 3 subgroups will be recruited from the oncology out-patient department;
- . 10 un-operated sigmoid rectal cancer patients (i.e. metastatic stage) before treatment and after 2 months of treatments with Avastin + 5FU + CPT only.
- . 10 un-operated sigmoid rectal cancer patients (i.e. metastatic stage) before treatment and after 2 months of treatments with Oxaliplatin + 5FU + Avastin.
- . 10 operated sigmoid rectal cancer patients before the operation and 2 months after the operation.
- . 10 control healthy subjects, age, sex and BMI matched.
Inclusion\Exclusion criteria:
Non diabetic and non-pregnant oncology patients above 18 years of age who are not on steroids and medications which can stimulate appetite.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nachum Vaisman, Prof., TASMC
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-07-NV-218-CTIL
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