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

June 10, 2014 updated by: Queensland Centre for Gynaecological Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • The Wesley Hospital
      • Brisbane, Queensland, Australia, 4000
        • Brisbane Private Hospital
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Health Services
      • Southport, Queensland, Australia, 4215
        • Gold Coast Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early post-operative enteral feeding
Standard post-operative care and diet together with early post-operative enteral feeding
Dietary supplement: 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.
No Intervention: Standard post-operative care and diet
Standard post-operative care and diet only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Time Frame: End of study

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
End of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay
Time Frame: Until discharge from hospital
Length of stay in an intensive care unit or high dependency unit and overall length of hospital stay.
Until discharge from hospital
Need for inotropic medications and intravenous treatment requirements
Time Frame: Until discharge from hospital
Until discharge from hospital
Nutritional status 6 weeks after surgery
Time Frame: 6 weeks after surgery
6 weeks after surgery
Treatment related adverse events
Time Frame: End of study
End of study
Delay and dose reductions of chemotherapy / quality of life during chemotherapy
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queensland Centre for Gynaecological Cancer

Collaborators

The University of Queensland
Cancer Australia Priority-driven Collaborative Cancer Research Scheme

Investigators

  • Study Chair: Andreas Obermair, MD FRANZCOG CGO, Queensland Centre for Gynaecological Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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