Design of the EFECTS Trial - Clinical Trial for Esophageal Cancer | NCT02017366

Back to results

Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Enteral feeding

About this trial

This is an interventional basic science trial for Esophageal Cancer focused on measuring Surgery, Malnutrition, Nutrition, Enteral

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

advanced cT2 N+ or cT3 Nx
all histology
GEJ or distal esophageal ACC
proximal or mid SCC
curative intent with intention to treat
no M+
at least two-field lymphadenectomy
all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis
all anastomosis (intrathoracic, cervical)

Exclusion Criteria:

T4
R2
transhiatal
pt in definitive CRT or rescue resection following definitive CRT
palliative treatment
tumours in cervical esophagus
pharyngeal cancer with gastric pull-up

Sites / Locations

University hospital Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Enteral feeding

Arm Description

Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks.

Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration.

Outcomes

Primary Outcome Measures

overall survival from day of surgery

overall survival at 5 years after esophagectomy

Secondary Outcome Measures

postoperative weight loss

weight loss will be calculated by using age- and gender corrected BMI percentiles

Full Information

NCT ID

NCT02017366

First Posted

December 16, 2013

Last Updated

December 19, 2013

Sponsor

University Hospital, Gasthuisberg

1. Study Identification

Unique Protocol Identification Number

NCT02017366

Brief Title

Design of the EFECTS Trial

Acronym

EFECTS

Official Title

Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Gasthuisberg

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer. We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively. We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

Surgery, Malnutrition, Nutrition, Enteral

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks.

Arm Title

Enteral feeding

Arm Type

Active Comparator

Arm Description

Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration.

Intervention Type

Other

Intervention Name(s)

Enteral feeding

Intervention Description

Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

Primary Outcome Measure Information:

Title

overall survival from day of surgery

Description

overall survival at 5 years after esophagectomy

Time Frame

5 years postoperative

Secondary Outcome Measure Information:

Title

postoperative weight loss

Description

weight loss will be calculated by using age- and gender corrected BMI percentiles

Time Frame

1 year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: advanced cT2 N+ or cT3 Nx all histology GEJ or distal esophageal ACC proximal or mid SCC curative intent with intention to treat no M+ at least two-field lymphadenectomy all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis all anastomosis (intrathoracic, cervical) Exclusion Criteria: T4 R2 transhiatal pt in definitive CRT or rescue resection following definitive CRT palliative treatment tumours in cervical esophagus pharyngeal cancer with gastric pull-up

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hans Van Veer, MD

Phone

+3216 341213

Email

Hans.Vanveer@uzleuven.be

First Name & Middle Initial & Last Name or Official Title & Degree

Johhny Moons, MScN

Phone

+3216 346825

Email

johnny.moons@uzleuven.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Van Veer, MD

Organizational Affiliation