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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00850772




Registration number
NCT00850772
Ethics application status
Date submitted
23/02/2009
Date registered
25/02/2009
Date last updated
12/06/2014

Titles & IDs
Public title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Scientific title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Secondary ID [1] 0 0
OPEN
Universal Trial Number (UTN)
Trial acronym
OPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Peritoneal Cancer 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Early post-operative enteral feeding

Experimental: Early post-operative enteral feeding - Standard post-operative care and diet together with early post-operative enteral feeding

No intervention: Standard post-operative care and diet - Standard post-operative care and diet only


Treatment: Other: Early post-operative enteral feeding
During primary surgical treatment an enteral feeding tube will be inserted through the patient's nose into their small bowel. Enteral feeding will commence 4 hours following return to ward from surgery. Feeding will start at a rate of 40 ml/hr for the first 24 hours, and then increased to goal weight. Goal will be calculated by 125 kiloJoules/kilogram adjusted body weight.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Timepoint [1] 0 0
End of study
Secondary outcome [1] 0 0
length of stay
Timepoint [1] 0 0
Until discharge from hospital
Secondary outcome [2] 0 0
Need for inotropic medications and intravenous treatment requirements
Timepoint [2] 0 0
Until discharge from hospital
Secondary outcome [3] 0 0
Nutritional status 6 weeks after surgery
Timepoint [3] 0 0
6 weeks after surgery
Secondary outcome [4] 0 0
Treatment related adverse events
Timepoint [4] 0 0
End of study
Secondary outcome [5] 0 0
Delay and dose reductions of chemotherapy / quality of life during chemotherapy
Timepoint [5] 0 0
End of study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
Brisbane Private Hospital - Brisbane
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [6] 0 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Queensland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00850772
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair, MD FRANZCOG CGO
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00850772