Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000547044
Ethics application status
Approved
Date submitted
2/07/2010
Date registered
8/07/2010
Date last updated
13/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early postoperative enteral feeding in patients with advanced epithelial ovarian cancer
Scientific title
A cost effectiveness and quality of life evaluation of early postoperative enteral feeding in patients with advanced epithelial ovarian cancer
Secondary ID [1] 252141 0
The ClinicalTrials.gov Identification: NCT00850772
Universal Trial Number (UTN)
U1111-1115-9381
Trial acronym
OPEN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary epithelial ovarian cancer 257675 0
Primary fallopian tube cancer 257676 0
Primary peritoneal cancer 257677 0
moderate malnourishment 257678 0
severe malnourishment 257679 0
Postoperative enteral feeding 257680 0
Condition category
Condition code
Diet and Nutrition 257856 257856 0 0
Other diet and nutrition disorders
Cancer 257857 257857 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Postoperative enteral feeding plus standard postoperative diet.
During surgery an enteral feeding tube will be inserted through the patient's nose into their small bowel. The location of the feeding tube is checked by the surgeon via palpation intra-operatively, as well as by plain x-ray postoperatively. A standard fibre containing enteral nutrition formula (4.2kJ/ml) will be fed through the nasojejunal tube postoperatively. Feeding will commence at a rate of 40mls/hr 4 hours after return to ward after surgery. Feeds will remain at this rate for the first 24 hours. The following day, feed rates will be increased to an individualised goal. The goal of enteral nutrition is to provide patients with 125 kilojoules per kilogram of body weight (adjusted using standard methodology for overweight patients). Patients randomised to early postoperative enteral feeding will be monitored daily by a nutritionist and will have their diet modified accordingly.
Patients randomised to postoperative enteral feeding can also commence standard postoperative diet on return to ward. This usually involves sips of water and clear fluid commencing on the return to the ward after surgery. This "standard diet" may vary slightly from institution to institution.
Intervention code [1] 256743 0
Treatment: Other
Comparator / control treatment
Standard postoperative diet.
The standard postoperative care will apply with intravenous fluids and increase in diet as tolerated. Patients will be reviewed based on their dietetic requirements and as per the local practice.
Standard postoperative diet usually consists of sips of water and clear fluids commencing on return to ward as tolerated by the patient. This practice may vary slightly from institution to institution.
Control group
Active

Outcomes
Primary outcome [1] 258718 0
Quality of life.
This study will use the FACT-O, an ovarian cancer specific quality of life measurement. This questionnaire will be completed by patients at Baseline, and at Follow Up #1 - 6 weeks after surgery, and Follow Up #2 - 30 days following the thirds cycle of postoperative chemotherapy.
The FACT-O is an ovarian cancer subscale that has been constructed to complement the FACT-G, addressing relevant disease, treatment, or condition related issues not already convered in the general FACT-G questionnaire. Each is intended to be as specific as necessary to capture the clinically relevant problems associated with a given condition or symptom, yet general enough to allow for comparison across diseases, and extension, as appropriate to other chronic medical conditions.
The FACT-G was developed by the Centre on Outcomes, Research and Education (CORE) to determine the quality of life of cancer patients, and the Functional Assessment of Cancer Therapy (FACT-G).
The FACT-O is a widely utilized quality of life questionnaire. It is a self-report scale and allows patients to rate their current physical, functional, social/family, and emotional well-being.
Timepoint [1] 258718 0
This questionnaire will be completed by patients at Baseline, and at Follow Up #1 - 6 weeks after surgery, and Follow Up #2 - 30 days following the thirds cycle of postoperative chemotherapy.
Primary outcome [2] 258719 0
Treatment costs and cost effectiveness.
The purpose of the analysis is to estimate the length of stay in the hospital and the difference in cost outcomes between the two arms. Patients in the control arm will have some observed length of stay in hospital. Patients in the intervention arm will incur the marginal costs of the feeding and will have some observed length of stay in hospital. The question we seek to address is whether the cost of the feeding is offset by the cost savings from any reductions in length of stay in hospital.

A model will be built that describes cost outcomes for each group, and these will be expressed as probability distributions. The costs of feeding will be recorded for each participant of the intervention arm and either a normal or lognormal distribution fitted to these data. The length of stay in hospital will be recorded for all participants and gamma distributions fitted for the intervention and the control groups using the method of moments approach.

The difference in costs between the two groups will be expressed as:

($ Cost of feeding + $ Cost of hospital stay for feeding group) less ($ Cost of hospital stay for controls)

Ten thousand random re-samples (bootstrapping) will then be taken from the distributions and the resulting posterior distribution estimated. This technique provides us with robust estimates. This will indicate the mean difference in dollar cost and then the probability that the difference is negative can be calculated. Negative costs imply the intervention is cost saving and positive costs imply the opposite. We assume long term patient outcomes are similar or no worse for feeding, and any adverse event, such as infection, will be captured by longer stays in hospital for the control group. The relevant cost outcome is the opportunity cost of a bed day and this can be valued in dollar terms outside of any statistical processes. Valuations will be informed by observing current levels of expenditure on hospital services by state health services, these data can be obtained easily from routine data published by the Australian Institute of Health and Welfare.
Timepoint [2] 258719 0
Postoperatively up until one month after third cycle of chemotherapy.
Secondary outcome [1] 264753 0
Length of stay in an Intensive Care Unit or High Dependency Unit and overall lengh of stay in hospital.
Timepoint [1] 264753 0
Admission to hospital until discharge from hospital
Secondary outcome [2] 264754 0
Need for inotropic medication.
All medication administered to the patient is recorded on a Case Report Form for the time period of randomisation through to 1 month following 3rd cycle of chemotherapy postoperatively.
Inotropic medication - given to support patient blood pressure and kidney function - is typically given during the surgery or day 1 or 2 postoperatively. These medications are ordered on medication sheets and then this information is transcribed onto the Case Report Form by the Trial Coordinator and then entered onto the trial database.
Timepoint [2] 264754 0
From surgery until discharge from hospital.
Secondary outcome [3] 264755 0
Intravenous treatment requirements.
All medication administered to the patient is recorded on a Case Report Form for the time period of randomisation through to 1 month following 3rd cycle of chemotherapy postoperatively.
Intravenous treatments are ordered on medication sheets and then this information is transcribed onto the Case Report Form by the Trial Coordinator and then entered onto the trial database.
Timepoint [3] 264755 0
From surgery until discharge from hospital.
Secondary outcome [4] 264756 0
Treatment related adverse events.
Any adverse change in health or side effect that occurs in a participant in this clinical trial while they are receiving enteral feeds, or from the the day of randomisation and up to one month after their third cycle of chemotherapy will be recorded.
Any event not present prior to treatment or any event already present that worsens in intensity or frequency will be recorded on a Case Report Form and graded in severity using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Adverse events will be documented at each study visit. Patients will be questioned regarding medically related change in their condition, and information will be gathered from data collected or communication with doctors or hospitals.
Timepoint [4] 264756 0
From randomisation until one month after third cycle of chemotherapy.
Secondary outcome [5] 264757 0
Delay and dose reductions of chemotherapy.
Start and finish dates for postoperative chemotherapy is recorded on Case Report Forms and entered onto the trial database. Trial Coordinators access medical correspondence regarding start times for chemotherapy and any reasons for delays in commencement of chemotherapy will be recorded. Medical notes for the duration of the chemotherapy schedule are accessed along with the dosages of chemotherapy given with each cycle. Any reasons for dosage reductions or interruptions to chemotherapy administration are noted on Case Report Forms.
Timepoint [5] 264757 0
Delay and dose reductions in chemotherapy would be assessed at Follow Up #2 - 1 month following third cycle of chemotherapy.
The Quality of Life questionnaire will be completed by patients at Baseline, and at Follow Up #1 - 6 weeks after surgery, and Follow Up #2 - 30 days following the thirds cycle of postoperative chemotherapy.
Secondary outcome [6] 264758 0
Nutritional status 6 weeks after surgery.

Scored patient-generated subjective global assessment (PG-SGA)
The scored PG-SGA is also a validated nutritional assessment tool and has been specifically developed for patients with cancer. The tool consists of a medical history component, which provides information about weight change, dietary intake, gastrointestinal symptoms (such as nausea, vomiting and diarrhoea that have persisted for two weeks) and changes in functional capacity. Loss of subcutaneous fat, muscle wasting, oedema and ascites will be considered in the physical examination. Based on the global assessment, the patient will be classified as category A (well nourished), category B (moderately or suspected malnourished) or category C (severely malnourished). In addition to the global ratings, the scored PG-SGA also incorporates a numerical score (PG-SGA score). For the overall PG-SGA score all point values for each section (patients history, physical examination) of the PG-SGA will be added. The additive PG-SGA score ranges from 0 to 50 with a higher score reflecting a greater risk of malnutrition. The PG-SGA score also provides cut-off scores for appropriate nutritional triage and intervention to improve symptom management. The PG-SGA has been accepted by the Oncology Nutrition Dietetic Practice Group of the American Dietetic Association as the standard for nutrition assessment for patients with cancer.
Timepoint [6] 264758 0
Follow up nutritional status until 6 weeks after surgery.

This will be completed at Visit one (pre-operative), Visit 3 (the day before planned discharge) , Follow Up #1 (6 weeks post surgery), and Follow Up #2(30 days following completion of the third cycle of chemotherapy).

Eligibility
Key inclusion criteria
Patients requiring planned upfront or interval cytoreductive surgery for suspected or histologically proven advanced ovarian, primary peritoneal cancer or fallopian tube cancer as determined jointly by the surgeon and the patient.

Signs of moderate or severe malnutrition. Patient Generated Subjective Global Assessment (PG-SGA) category B or C

Medically fit for cytoreductive surgery

Signed written informed consent form

Females aged 18 years or older

Able to understand and complete questionnaires in English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Other histological type than epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer

Recurrent epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer

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

Positive urinary pregnancy test 10 days prior to surgery in a pre-menopausal lady and/or women <2years after menopause who are not surgically sterile.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients attending Gynaecology/Oncology Clinics at recruiting hospitals with a suspected or proven diagnosis of primary ovarian, fallopian tube or peritoneal cancer who are scheduled for their primary cytoreductive surgery are screened for malnourishment using the Patient Generated Subjective Global Assessment (PG-SGA). Inclusion and Exclusion criteria are used to screen all patients. Patients are randomised to one of two equally sized groups - early postoperative enteral feeding and standard postoperative care versus standard postoperative care alone. Randomisation is equal between the two arms (1:1) with stratification by treatment centre and mode (upfront surgery versus neoadjuvant chemotherapy) to ensure balance across treatments. Following the process of informed consent all eligible patients will be required to sign a consent form before they can be randomised.
The randomisation procedure for the treatment type is centrally organised for all investigators. At the time the patient is enrolled in the study, the surgeon/trial coordinator will open the next envelope in the sequence to determine which of the two treatment types will be used for postoperative nutritional care. Envelopes are organised into treatment centres and mode (upfront surgery or neoadjuvant chemotherapy).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised permuted blocks will be used to allocate patients between the two treatment groups with an allocation ratio of 1:1. The randomisation scheme will ensure that during the enrolment period the ratio of the number of cases in the two groups remain approximately constant. Permuted block randomisation is combined with stratified randomisation. The randomisation process is stratified for treatment centre and mode (upfront surgery versus neoadjuvant chemotherapy). Any deviation from the assigned treatment will be reported as a deviation from Protocol.
Allocation concealment includes sequentially numbered, opaque, sealed envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/02/2009
Actual
8/02/2009
Date of last participant enrolment
Anticipated
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3022 0
4029
Recruitment postcode(s) [2] 3023 0
4101
Recruitment postcode(s) [3] 3024 0
4120
Recruitment postcode(s) [4] 3025 0
4066
Recruitment postcode(s) [5] 3475 0
4215
Recruitment postcode(s) [6] 3476 0
4000

Funding & Sponsors
Funding source category [1] 257239 0
Government body
Name [1] 257239 0
Cancer Australia
Country [1] 257239 0
Australia
Funding source category [2] 257240 0
Charities/Societies/Foundations
Name [2] 257240 0
Gallipoli Research Foundation
Country [2] 257240 0
Australia
Funding source category [3] 257241 0
Charities/Societies/Foundations
Name [3] 257241 0
Wesley Research Institute
Country [3] 257241 0
Australia
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Level 6
Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
Herston Qld 4209
Country
Australia
Secondary sponsor category [1] 256484 0
None
Name [1] 256484 0
Address [1] 256484 0
Country [1] 256484 0
Other collaborator category [1] 251362 0
University
Name [1] 251362 0
University of Queensland
Address [1] 251362 0
Sir Fred Schonnell Drive
St Lucia Qld 4067
Country [1] 251362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259251 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 259251 0
Ethics committee country [1] 259251 0
Australia
Date submitted for ethics approval [1] 259251 0
13/10/2008
Approval date [1] 259251 0
21/11/2008
Ethics approval number [1] 259251 0
2008/069
Ethics committee name [2] 259252 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [2] 259252 0
Ethics committee country [2] 259252 0
Australia
Date submitted for ethics approval [2] 259252 0
07/01/2009
Approval date [2] 259252 0
26/02/2009
Ethics approval number [2] 259252 0
200901
Ethics committee name [3] 259253 0
Greenslopes Human Research Ethics Committee
Ethics committee address [3] 259253 0
Ethics committee country [3] 259253 0
Australia
Date submitted for ethics approval [3] 259253 0
07/01/2009
Approval date [3] 259253 0
13/04/2010
Ethics approval number [3] 259253 0
9/06/2010
Ethics committee name [4] 259254 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [4] 259254 0
Ethics committee country [4] 259254 0
Australia
Date submitted for ethics approval [4] 259254 0
01/03/2010
Approval date [4] 259254 0
22/04/2010
Ethics approval number [4] 259254 0
1492A
Ethics committee name [5] 259255 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [5] 259255 0
Ethics committee country [5] 259255 0
Australia
Date submitted for ethics approval [5] 259255 0
04/12/2008
Approval date [5] 259255 0
10/12/2008
Ethics approval number [5] 259255 0
2008002215
Ethics committee name [6] 260111 0
Mater Health Services Human Reseach Ethics Committee (for Brisbane Private Hospital)
Ethics committee address [6] 260111 0
Ethics committee country [6] 260111 0
Australia
Date submitted for ethics approval [6] 260111 0
09/07/2010
Approval date [6] 260111 0
26/08/2010
Ethics approval number [6] 260111 0
1492A
Ethics committee name [7] 260112 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [7] 260112 0
Ethics committee country [7] 260112 0
Australia
Date submitted for ethics approval [7] 260112 0
19/07/2010
Approval date [7] 260112 0
24/08/2010
Ethics approval number [7] 260112 0
HREC/10/QGC/121

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31357 0
Prof Andreas Obermair
Address 31357 0
Queensland Centre for Gynaecological Cancer Level 6 Ned Hanlon Building Royal Brisbane and Women's Hospital Herston Road Herston Qld 4029
Country 31357 0
Australia
Phone 31357 0
+61 7 3646 8501
Fax 31357 0
Email 31357 0
[email protected]
Contact person for public queries
Name 14604 0
Dana Middleton
Address 14604 0
Queensland Centre for Gynaecological Cancer
Level 6 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
Herston Qld 4029
Country 14604 0
Australia
Phone 14604 0
+61 7 3636 0857
Fax 14604 0
+61 7 3636 1721
Email 14604 0
[email protected]
Contact person for scientific queries
Name 5532 0
Professor Andreas Obermair
Address 5532 0
Queensland Centre for Gynaecological Cancer
Level 6 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
Herston Qld 4029
Country 5532 0
Australia
Phone 5532 0
+61 7 3646 8501
Fax 5532 0
+ 61 7 3546 5289
Email 5532 0
[email protected]

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