Status:
COMPLETED
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborating Sponsors:
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
The University of Queensland
Conditions:
Epithelial Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of appetite and reduced food intake. Being malnourished can contribute to the incidence and severity of cancer tr...
Eligibility Criteria
Inclusion
- 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
- Other histological type than ovarian cancer, peritoneal cancer or fallopian tube cancer
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00850772
Start Date
January 1 2009
End Date
August 1 2013
Last Update
June 12 2014
Active Locations (6)
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1
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
2
Brisbane Private Hospital
Brisbane, Queensland, Australia, 4000
3
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
4
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029