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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Athina-Despina Kimpizi contact

00302132088142

despinakimpizi@yahoo.com

Greece1 site, 1 recruiting
  • Hippocration Hospital

    Athens

    Athina-Despoina Kimpizi, +302132088142, despinakimpizi@yahoo.com

    Recruiting

Other trials in Greece

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.

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 groups in NCT04190121
Study groupRoleWhat they receive
GROUP AExperimentalNot described
Receives: Dietary Supplement: prosure
GROUP BNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. infective complications

    surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis

    Measured: first six postoperative months

Secondary outcomes (7)
  1. anastomotic leak

    anastomotic leak confirmed either by a CT scan or upper gastrointestinal series

    Measured: first six postoperative months

  2. postoperative arrhythmia or other cardiac complications

    cardiac complications confirmed by ECG that required consultation by a cardiologist

    Measured: first six postoperative months

  3. readmission rate

    Measured: first six postoperative months

  4. reoperation

    need for reoperation due to postoperative complications in the first six postoperative months

    Measured: first six postoperative months

  5. disease-associated death during the first six postoperative months

    death related to the known malignancy,including postoperative complications

    Measured: first six postoperative months

  6. length of hospital stay

    postoperative duration of hospital stay

    Measured: first six postoperative months (including first admission and any other readmission)

  7. 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.

  1. First posted9 Dec 2019
  2. Study start26 Mar 2019
  3. Primary completion14 Feb 2022 (estimated)
  4. Study completion14 Feb 2022 (estimated)

Resources

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)
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

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.

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