NCT04190121

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

2.9 years

First QC Date

December 4, 2019

Last Update Submit

December 5, 2019

Conditions

Esophageal CancerNutritional Deficiency

Keywords

esophageal cancer,nutritional support

Outcome Measures

Primary Outcomes (1)

  • infective complications

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

    first six postoperative months

Secondary Outcomes (7)

  • anastomotic leak

    first six postoperative months

  • postoperative arrhythmia or other cardiac complications

    first six postoperative months

  • readmission rate

    first six postoperative months

  • reoperation

    first six postoperative months

  • disease-associated death during the first six postoperative months

    first six postoperative months

  • +2 more secondary outcomes

Other Outcomes (4)

  • patient's BMI changes

    first six postoperative months

  • patient's muscle mass changes

    first six postoperative months

  • patient's body fat changes

    first six postoperative months

  • +1 more other outcomes

Study Arms (2)

GROUP A

EXPERIMENTAL
Dietary Supplement: prosure

GROUP B

NO INTERVENTION

Interventions

prosureDIETARY_SUPPLEMENT

The study group will receive the dietary supplement preoperatively and for three months after the operation

GROUP A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with esophageal cancer
  • years or older

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippocration Hospital

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Dimitrios Theodorou

    Hippocration Hospital

    STUDY CHAIR

  • Athina-Despina Kimpizi

    Hippocration Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Athina-Despina Kimpizi

CONTACT

00302132088142despinakimpizi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 9, 2019

Study Start

March 26, 2019

Primary Completion

February 14, 2022

Study Completion

February 14, 2022

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

GR(1)