Brief Title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Official Title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
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 treatment side effects and increase the risk of infection. Currently
patients with advanced ovarian cancer do not receive early nutrition using a feeding tube.
The purpose of this study is to compare enteral nutrition along with standard post-surgery
care against current standard post-operative care alone. This study will see if early
nutrition using a feeding tube has an impact on length of hospital admission, recovery from
surgery, complications from surgery, nutritional status and ultimately a reduction in
treatment costs in people with Advanced Epithelial Ovarian Cancer (EOC). Primary Peritoneal
Cancer (PPC) or Fallopian Tube Cancer. Nutritional support has been shown to ;
- Prevent and treat under-nutrition,
- Enhance anti-tumour treatment effects,
- Reduce adverse effects of anti-tumour therapies,
- Improve quality of life.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Secondary Outcome
length of stay
Condition
Epithelial Ovarian Cancer
Intervention
Early post-operative enteral feeding
Study Arms / Comparison Groups
Early post-operative enteral feeding
Description: Standard post-operative care and diet together with early post-operative enteral feeding
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
109
Start Date
January 2009
Completion Date
August 2013
Primary Completion Date
August 2013
Eligibility Criteria
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
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andreas Obermair, MD FRANZCOG CGO, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00850772
Organization ID
OPEN
Responsible Party
Sponsor
Study Sponsor
Queensland Centre for Gynaecological Cancer
Collaborators
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
Study Sponsor
Andreas Obermair, MD FRANZCOG CGO, Study Chair, Queensland Centre for Gynaecological Cancer
Verification Date
June 2014