Esophageal CancerNEECNCT04190121
Perioperative Nutritional Support in Esophageal Cancer Patients
A study testing prosure in people with Esophageal Cancer and Nutritional Deficiency, run by THEODOROU DIMITRIOS at 1 site in Greece.
Trial summary
Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Nutritional Deficiency
- What is being tested?
- prosure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGreece
- Study dates
- 26 Mar 2019to 14 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with esophageal cancer
- 18 years or older
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hippocration Hospital
Athens
Athina-Despoina Kimpizi, +302132088142, despinakimpizi@yahoo.com
About this study
Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. This prospective randomized trial aims to investigate the above mentioned hypothesis and clarify any variants that may differ between the investigation and control group at a statistically significant level.
Read the detailed description
This prospective randomized trial is conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. The study population consists of adults suffering from upper GI malignancy. Informed consent is obtained in written. Following this, the patient is classified in either the intervention group or the control group. Patients belonging in the control group will receive the usual postoperative care, while the patients in the intervention group will receive nutritional support perioperatively. The aforementioned "usual postoperative care" consists of administration of intravenous fluids until resuming oral feeding, jejunostomy feeding starting from the first postoperative day, epidural analgesics for the first four postoperative days, perioperative administration of a second generation cephalosporin plus metronidazole and thromboprophylaxis with (low moleculr weight heparin (LMWH). The patients are also receiving appropriate for any concomitant health problems (e.g. existing diabetes mellitus) and transfusions based on their needs. We record the patient's age, the stage and histologic type of the disease, administration of adjuvant and/or neoadjuvant therapy and the patient's American Society of Anesthesiologists Score. Their preoperative nutritional state will be assessed using Body Mass Index (BMI), serum albumin, body fat percentage, muscle mass and total body water following measurement with body composition analyzer (Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer). At their initial assessment the patients will fill in an appropriate quality of life questionnaire. The type of the operation, the use of drains and catheters, the patients needs in iv fluids, blood product transfusions, sedatives and analgesics during the operation will also be recorded. The postoperative course of any patient will be closely monitored, including the postoperative needs in fluid administration and analgesics, the need for transfusion, the administration of perioperative antibiotics, the removal of drains and catheters, the time of first bowel movement,the need of ICU hospitalization, the total length of hospital stay as well as any in-hospital complications. Upon discharge from the hospital, the control group will receive instructions on oral and jejunostomy feeding, while the intervention group will receive additional nutritional support for 3 months. Both patient groups will undergo post-operative follow-up for six months. In the first, third and sixth postoperative month body weight and its change, BMI, serum albumin, body fat percentage, muscle mass and total body water, as well as quality of life, postoperative complications and need for readmission will be evaluated. Neoadjuvant therapy will also be taken into account. The results will be statistically evaluated after appropriate stratification.
- Conditions
- Esophageal Cancer, Nutritional Deficiency
- Being tested
- prosure
- Keywords
- esophageal cancer,nutritional support
- Medical subject headings
- Esophageal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosureDietary supplement
The study group will receive the dietary supplement preoperatively and for three months after the operation
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Experimental | Not described Receives: Dietary Supplement: prosure |
| GROUP B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
infective complications
surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis
Measured: first six postoperative months
Secondary outcomes (7)
anastomotic leak
anastomotic leak confirmed either by a CT scan or upper gastrointestinal series
Measured: first six postoperative months
postoperative arrhythmia or other cardiac complications
cardiac complications confirmed by ECG that required consultation by a cardiologist
Measured: first six postoperative months
readmission rate
Measured: first six postoperative months
reoperation
need for reoperation due to postoperative complications in the first six postoperative months
Measured: first six postoperative months
disease-associated death during the first six postoperative months
death related to the known malignancy,including postoperative complications
Measured: first six postoperative months
length of hospital stay
postoperative duration of hospital stay
Measured: first six postoperative months (including first admission and any other readmission)
length of stay in the ICU
Measured: first six postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start26 Mar 2019
- Primary completion14 Feb 2022 (estimated)
- Study completion14 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- THEODOROU DIMITRIOS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, THEODOROU DIMITRIOS, University of Athens
- Investigators
- Dimitrios Theodorou, Study chair, Hippocration HospitalAthina-Despina Kimpizi, Principal investigator, Hippocration Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190121
- Sponsor's protocol ID
- 17771
- Acronym
- NEEC
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutritional Support in Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT04190121
- Acronym / sponsor ID
- NEEC / 17771
- Conditions
- Esophageal Cancer, Nutritional Deficiency
- Keywords
- esophageal cancer,nutritional support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- THEODOROU DIMITRIOSUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 14 Feb 2022 (estimated)
- Study completion
- 14 Feb 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. This prospective randomized trial aims to investigate the above mentioned hypothesis and clarify any variants that may differ between the investigation and control group at a statistically significant level.
Detailed description
This prospective randomized trial is conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. The study population consists of adults suffering from upper GI malignancy. Informed consent is obtained in written. Following this, the patient is classified in either the intervention group or the control group. Patients belonging in the control group will receive the usual postoperative care, while the patients in the intervention group will receive nutritional support perioperatively. The aforementioned "usual postoperative care" consists of administration of intravenous fluids until resuming oral feeding, jejunostomy feeding starting from the first postoperative day, epidural analgesics for the first four postoperative days, perioperative administration of a second generation cephalosporin plus metronidazole and thromboprophylaxis with (low moleculr weight heparin (LMWH). The patients are also receiving appropriate for any concomitant health problems (e.g. existing diabetes mellitus) and transfusions based on their needs. We record the patient's age, the stage and histologic type of the disease, administration of adjuvant and/or neoadjuvant therapy and the patient's American Society of Anesthesiologists Score. Their preoperative nutritional state will be assessed using Body Mass Index (BMI), serum albumin, body fat percentage, muscle mass and total body water following measurement with body composition analyzer (Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer). At their initial assessment the patients will fill in an appropriate quality of life questionnaire. The type of the operation, the use of drains and catheters, the patients needs in iv fluids, blood product transfusions, sedatives and analgesics during the operation will also be recorded. The postoperative course of any patient will be closely monitored, including the postoperative needs in fluid administration and analgesics, the need for transfusion, the administration of perioperative antibiotics, the removal of drains and catheters, the time of first bowel movement,the need of ICU hospitalization, the total length of hospital stay as well as any in-hospital complications. Upon discharge from the hospital, the control group will receive instructions on oral and jejunostomy feeding, while the intervention group will receive additional nutritional support for 3 months. Both patient groups will undergo post-operative follow-up for six months. In the first, third and sixth postoperative month body weight and its change, BMI, serum albumin, body fat percentage, muscle mass and total body water, as well as quality of life, postoperative complications and need for readmission will be evaluated. Neoadjuvant therapy will also be taken into account. The results will be statistically evaluated after appropriate stratification.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Dietary Supplement: prosure |
| GROUP B | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with esophageal cancer
- 18 years or older
Key exclusion criteria (1 listed)
- -none
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 |
|---|---|---|
| prosureThe study group will receive the dietary supplement preoperatively and for three months after the operation | Dietary supplement | GROUP A |
Primary outcome
infective complications
Time frame: first six postoperative months
surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis
7 secondary outcomes
anastomotic leak
Time frame: first six postoperative months
postoperative arrhythmia or other cardiac complications
Time frame: first six postoperative months
readmission rate
Time frame: first six postoperative months
reoperation
Time frame: first six postoperative months
disease-associated death during the first six postoperative months
Time frame: first six postoperative months
length of hospital stay
Time frame: first six postoperative months (including first admission and any other readmission)
length of stay in the ICU
Time frame: first six postoperative months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
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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.
Dimitrios Theodorou study chair
Hippocration Hospital
Athina-Despina Kimpizi principal investigator
Hippocration Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prosure in people with Esophageal Cancer and Nutritional Deficiency, run by THEODOROU DIMITRIOS at 1 site in Greece.
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 2 inclusion and 1 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 9 Dec 2019. 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 Greece. 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 Athina-Despina Kimpizi (00302132088142, despinakimpizi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infective complications (time frame: first six postoperative months). 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 9 Dec 2019.