Cephalic Phase, Oncology PatientsCephalic chemoNCT00493740
Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls
A study testing chocolate cake in people with Cephalic Phase, Oncology Patients, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cephalic Phase, Oncology Patients
- What is being tested?
- chocolate cake
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non diabetic and non-pregnant oncology patients above 18 years of age who are not on steroids and medications which can stimulate appetite.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Nachum Vaisman, Prof., +972-524-266596, vaisman@tasmc.health.gov.il
Nachum Vaisman, Prof.
About this study
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.
Read the 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.
- Conditions
- Cephalic Phase, Oncology Patients
- Being tested
- chocolate cake
- Keywords
- Cephalic phase, oncology patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chocolate cakeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cephalic Phase, Oncology PatientsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof., Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493740
- Sponsor's protocol ID
- TASMC-07-NV-218-CTIL
- Acronym
- Cephalic chemo
- Status last verified
- Jun 2007
- First submitted
- 27 Jun 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cephalic Phase of Oncology Patients Before and After Chemotherapy as Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT00493740
- Acronym / sponsor ID
- Cephalic chemo / TASMC-07-NV-218-CTIL
- Conditions
- Cephalic Phase, Oncology Patients
- Keywords
- Cephalic phase, oncology patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non diabetic and non-pregnant oncology patients above 18 years of age who are not on steroids and medications which can stimulate appetite.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chocolate cake | Procedure or surgery | – |
Primary outcome
VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Vaisman, Prof. principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chocolate cake in people with Cephalic Phase, Oncology Patients, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof. (+972-524-266-596, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2007.