Esophageal CancerEFECTSNCT02017366
Design of the EFECTS Trial
A study testing Enteral feeding in people with Esophageal Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Enteral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2018to Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+
Show all 9Show fewer
- at least two-field lymphadenectomy
- all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis
- all anastomosis (intrathoracic, cervical)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
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.
- Conditions
- Esophageal Cancer
- Being tested
- Enteral feeding
- Keywords
- Surgery, Malnutrition, Nutrition, Enteral
- 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.
Enteral feedingOther
Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Enteral feeding | Active comparator | 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. Receives: Other: Enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival from day of surgery
overall survival at 5 years after esophagectomy
Measured: 5 years postoperative
Secondary outcomes (1)
postoperative weight loss
weight loss will be calculated by using age- and gender corrected BMI percentiles
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startOct 2018 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Van Veer, MD, University Hospital, Gasthuisberg
- Investigators
- Hans Van Veer, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenPhilippe Nafteux, MD, Study chair, Universitaire Ziekenhuizen KU LeuvenWilly Coosemans, MD, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenJohnny Moons, MScN, Study chair, Universitaire Ziekenhuizen KU LeuvenPaul De Leyn, MD, PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017366
- Sponsor's protocol ID
- EFECTS
- Acronym
- EFECTS
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2013
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
- ClinicalTrials.gov ID
- NCT02017366
- Acronym / sponsor ID
- EFECTS / EFECTS
- Conditions
- Esophageal Cancer
- Keywords
- Surgery, Malnutrition, Nutrition, Enteral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: adapted protocol with changed outcome measures, changed recruitment number, no submission to ethical board review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 20 Dec 2013 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Enteral feeding | Active comparator | Other: Enteral feedingTreatment 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- advanced cT2 N+ or cT3 Nx
- all histology
- GEJ or distal esophageal ACC
- proximal or mid SCC
- curative intent with intention to treat
Key exclusion criteria (7 listed)
- T4
- R2
- transhiatal
- pt in definitive CRT or rescue resection following definitive CRT
- palliative treatment
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 |
|---|---|---|
| Enteral feedingTarget of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight. | Other | Enteral feeding |
Primary outcome
overall survival from day of surgery
Time frame: 5 years postoperative
overall survival at 5 years after esophagectomy
1 secondary outcome
postoperative weight loss
Time frame: 1 year after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Hans Van Veer, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Philippe Nafteux, MD study chair
Universitaire Ziekenhuizen KU Leuven
Willy Coosemans, MD, PhD study chair
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral feeding in people with Esophageal Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Dec 2023. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival from day of surgery (time frame: 5 years postoperative). 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 Dec 2023.