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Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer (OPEN)

Primary Purpose

Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Early post-operative enteral feeding
Sponsored by
Queensland Centre for Gynaecological Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epithelial Ovarian Cancer focused on measuring Enteral nutrition, Ovarian cancer, Peritoneal cancer, Fallopian tube cancer, Malnutrition, Surgery, Gynecological Cancer, Suspected advanced epithelial ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Wesley Hospital
  • Brisbane Private Hospital
  • Greenslopes Private Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Health Services
  • Gold Coast Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early post-operative enteral feeding

Standard post-operative care and diet

Arm Description

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

Standard post-operative care and diet only

Outcomes

Primary Outcome Measures

Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Compare treatment costs and cost effectiveness between early enteral feeding with standard post-operative care versus current standard ost-operative care for advanced epithelial ovarian cancer. Compare quality of life after surgery between women who receive early enteral feeding along with standard post-operative care versus those who receive current standard post-operative care for advanced epithelial ovarian cancer

Secondary Outcome Measures

length of stay
Length of stay in an intensive care unit or high dependency unit and overall length of hospital stay.
Need for inotropic medications and intravenous treatment requirements
Nutritional status 6 weeks after surgery
Treatment related adverse events
Delay and dose reductions of chemotherapy / quality of life during chemotherapy

Full Information

First Posted
February 23, 2009
Last Updated
June 10, 2014
Sponsor
Queensland Centre for Gynaecological Cancer
Collaborators
Cancer Australia Priority-driven Collaborative Cancer Research Scheme, The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT00850772
Brief Title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Acronym
OPEN
Official Title
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queensland Centre for Gynaecological Cancer
Collaborators
Cancer Australia Priority-driven Collaborative Cancer Research Scheme, The University of Queensland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early post-operative enteral feeding
Arm Type
Experimental
Arm Description
Standard post-operative care and diet together with early post-operative enteral feeding
Arm Title
Standard post-operative care and diet
Arm Type
No Intervention
Arm Description
Standard post-operative care and diet only
Intervention Type
Dietary Supplement
Intervention Name(s)
Early post-operative enteral feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Description
Compare treatment costs and cost effectiveness between early enteral feeding with standard post-operative care versus current standard ost-operative care for advanced epithelial ovarian cancer. Compare quality of life after surgery between women who receive early enteral feeding along with standard post-operative care versus those who receive current standard post-operative care for advanced epithelial ovarian cancer
Time Frame
End of study
Secondary Outcome Measure Information:
Title
length of stay
Description
Length of stay in an intensive care unit or high dependency unit and overall length of hospital stay.
Time Frame
Until discharge from hospital
Title
Need for inotropic medications and intravenous treatment requirements
Time Frame
Until discharge from hospital
Title
Nutritional status 6 weeks after surgery
Time Frame
6 weeks after surgery
Title
Treatment related adverse events
Time Frame
End of study
Title
Delay and dose reductions of chemotherapy / quality of life during chemotherapy
Time Frame
End of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Obermair, MD FRANZCOG CGO
Organizational Affiliation
Queensland Centre for Gynaecological Cancer
Official's Role
Study Chair
Facility Information:
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Brisbane Private Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Health Services
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25827292
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.
Results Reference
derived

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Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer

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