Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls (Cephalic chemo)
Recruitment status was Recruiting
Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | July 5, 2007 | ||||
Start Date ICMJE | July 2007 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure [ Time Frame: 1 year ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00493740 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls | ||||
Official Title ICMJE | Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls | ||||
Brief Summary | The objective of this trial is to examine the cephalic phase insulin response (CPIR) and pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and magnitude to palatable food stimulus (chocolate cake) in oncology patients before and after chemotherapy treatment as compared to healthy controls . This may enlighten our understanding of the etiology of taste dysfunction and anorexia during chemotherapy treatments. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
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Condition ICMJE | Cephalic Phase, Oncology Patients | ||||
Intervention ICMJE | Procedure: chocolate cake | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | December 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Subjects: 40 oncology patients of the following 3 subgroups will be recruited from the oncology out-patient department;
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. |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493740 | ||||
Other Study ID Numbers ICMJE | TASMC-07-NV-218-CTIL | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | |||||
Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
Verification Date | June 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |