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Status unknownNCT01839617PaNCSUpdated Feb 7, 2018

Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery

An interventional study of Early parenteral nutrition and Late parenteral nutrition in Cancer, Abdominal Surgery and Parenteral Nutrition, sponsored by Instituto do Cancer do Estado de São Paulo. Status unknown at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Instituto do Cancer do Estado de São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
335
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

Read the detailed description

There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.

This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.

Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.

Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.

Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.

02

Conditions studied

  • Cancer
  • Abdominal Surgery
  • Parenteral Nutrition

Keywords

  • parenteral nutrition
  • early nutrition
  • abdominal surgery
  • cancer
03

In context

Lead sponsor

Instituto do Cancer do Estado de São Paulo is the lead sponsor of 90 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Older than 18 years
  • Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular.
  • Informed consent form signed by the patient or legal guardian.

Exclusion criteria

Exclusion Criteria:

  • Reoperation within one year from the previous surgery. using previously parenteral nutrition.
  • Participation in another research protocol.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
335 participants (actual)

Study arms

  • Active comparator
    Early parenteral nutrition

    Parenteral nutrition starts at 2nd postoperative day.

    Dietary Supplement: Early parenteral nutrition

  • Active comparator
    Late parenteral nutrition

    Parenteral nutrition starts at 7th postoperative day.

    Dietary Supplement: Late parenteral nutrition

Interventions

  • Dietary supplementEarly parenteral nutrition
  • Dietary supplementLate parenteral nutrition
06

What researchers measure

Primary outcomes

  1. Clinical complications

    respiratory, cardiovascular, renal, neurological, infectious, surgical

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    30-day mortality

    Time frame: 30 days

  2. Length of stay in ICU and in hospital

    Length of stay

    Time frame: 30 days

  3. ICU readmission rate

    ICU readmission rate

    Time frame: 30 days

  4. Duration of pharmacologic hemodynamic support

    duration of vasopressor therapy

    Time frame: 30 days

  5. Levels of C-reactive protein

    serum levels of C-reactive protein

    Time frame: 7 days

  6. Duration of mechanical ventilation

    Duration of invasive mechanical ventilation

    Time frame: 30 days

  7. Liver dysfunction

    liver dysfunction according SOFA

    Time frame: 30 days

07

Study locations

2 sites
  • ICESP
    Sao Paulo, SP 01414001, Brazil
  • Cancer Institute of the State of Sao Paulo
    São Paulo, SP 01246-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01839617
Lead sponsor
Instituto do Cancer do Estado de São Paulo
Responsible party
Patrícia Camargo Marques (Principal Investigator, Instituto do Cancer do Estado de São Paulo) — Principal investigator
First posted
Apr 25, 2013
Start date
May 7, 2013
Primary completion
Jun 27, 2016
Completion
Apr 10, 2018 (estimated)
Last update
Feb 7, 2018

Study contacts

Patricia Marques, MD
principal investigator · Instituto do Cancer do Estado de São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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