Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls (Cephalic chemo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00493740
First received: June 27, 2007
Last updated: July 5, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Cephalic Phase, Oncology Patients
Procedure: chocolate cake

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure [ Time Frame: 1 year ]

Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Subjects:

40 oncology patients of the following 3 subgroups will be recruited from the oncology out-patient department;

  1. . 10 un-operated sigmoid rectal cancer patients (i.e. metastatic stage) before treatment and after 2 months of treatments with Avastin + 5FU + CPT only.
  2. . 10 un-operated sigmoid rectal cancer patients (i.e. metastatic stage) before treatment and after 2 months of treatments with Oxaliplatin + 5FU + Avastin.
  3. . 10 operated sigmoid rectal cancer patients before the operation and 2 months after the operation.
  4. . 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493740

Contacts
Contact: Nachum Vaisman, Prof. +972-524-266-596 vaisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof.    +972-524-266596    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof. TASMC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00493740     History of Changes
Other Study ID Numbers: TASMC-07-NV-218-CTIL
Study First Received: June 27, 2007
Last Updated: July 5, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Cephalic phase, oncology patients

ClinicalTrials.gov processed this record on July 28, 2014