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Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer

Phase 3
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer

Inclusion Criteria:

- Patients requiring planned primary surgery for suspected or histologically proven
advanced ovarian, primary peritoneal cancer or fallopian tube cancer.

- Signs of moderate or severe malnutrition - Patient Generated Subjective Global
Assessment (PG-SGA) Category B or C and/or a total numerical score of 4 or more in
the PG-SGA

- Medically fit for primary surgery

- Signed written informed consent

- Females aged 18 years or older

Exclusion Criteria:

- Other histological type than ovarian cancer, peritoneal cancer or fallopian tube

- Recurrent ovarian cancer, peritoneal or fallopian tube cancer

- Pre-existing contraindications to enteral nutrition such as ileus, gastrointestinal
ischemia, bilious or persistent vomiting, or mechanical obstruction

- Positive urine pregnancy test

- Unfit for surgery; serious concomitant systemic disorders incompatible with the study
(at the discretion of the investigator)

- Participation in other clinical trials that may have an impact on the outcomes of
this trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life

Outcome Description:

Compare treatment costs and cost effectiveness between early enteral feeding with standard post-operative care versus current standard ost-operative care for advanced epithelial ovarian cancer. Compare quality of life after surgery between women who receive early enteral feeding along with standard post-operative care versus those who receive current standard post-operative care for advanced epithelial ovarian cancer

Outcome Time Frame:

End of study

Safety Issue:


Principal Investigator

Andreas Obermair, MD FRANZCOG CGO

Investigator Role:

Study Chair

Investigator Affiliation:

Queensland Centre for Gynaecological Cancer


Australia: Human Research Ethics Committee

Study ID:




Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Enteral nutrition
  • Ovarian cancer
  • Peritoneal cancer
  • Fallopian tube cancer
  • Malnutrition
  • Surgery
  • Gynecological Cancer
  • Suspected advanced epithelial ovarian cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial