Clinical trial NCT00850772: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Enteral nutrition
Ovarian cancer
Peritoneal cancer
Fallopian tube cancer
Malnutrition
Surgery
Gynecological Cancer
Suspected advanced epithelial ovarian cancer
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
Collaborators: name: Cancer Australia Priority-driven Collaborative Cancer Research Scheme
name: The University of Queensland
First posted: 2009-02-25
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
timeFrame: End of study
Secondary outcomes:
measure: length of stay
timeFrame: Until discharge from hospital
measure: Need for inotropic medications and intravenous treatment requirements
timeFrame: Until discharge from hospital
measure: Nutritional status 6 weeks after surgery
timeFrame: 6 weeks after surgery
measure: Treatment related adverse events
timeFrame: End of study
measure: Delay and dose reductions of chemotherapy / quality of life during chemotherapy
timeFrame: End of study
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: The Wesley Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Brisbane Private Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
Study officials:
affiliation: Queensland Centre for Gynaecological Cancer
name: Andreas Obermair, MD FRANZCOG CGO
role: STUDY_CHAIR
References:
citation: Baker J, Janda M, Graves N, Bauer J, Banks M, Garrett A, Chetty N, Crandon AJ, Land R, Nascimento M, Nicklin JL, Perrin LC, Obermair A. Quality of life after early enteral feeding versus standard care for proven or suspected advanced epithelial ovarian cancer: Results from a randomised trial. Gynecol Oncol. 2015 Jun;137(3):516-22. doi: 10.1016/j.ygyno.2015.03.048. Epub 2015 Mar 28.