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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
The University of Queensland
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00850772
First received: February 23, 2009
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention Phase
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Dietary Supplement: Early post-operative enteral feeding
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life [ Time Frame: End of study ] [ Designated as safety issue: No ]

    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 [ Time Frame: Until discharge from hospital ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Until discharge from hospital ] [ Designated as safety issue: Yes ]
  • Nutritional status 6 weeks after surgery [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]
  • Treatment related adverse events [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • Delay and dose reductions of chemotherapy / quality of life during chemotherapy [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850772

Locations
Australia, Queensland
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Brisbane Private Hospital
Brisbane, Queensland, Australia, 4000
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Health Services
South Brisbane, Queensland, Australia, 4101
Gold Coast Hospital
Southport, Queensland, Australia, 4215
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
The University of Queensland
Investigators
Study Chair: Andreas Obermair, MD FRANZCOG CGO Queensland Centre for Gynaecological Cancer
  More Information

No publications provided

Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00850772     History of Changes
Other Study ID Numbers: OPEN
Study First Received: February 23, 2009
Last Updated: April 22, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Queensland Centre for Gynaecological Cancer:
Enteral nutrition
Ovarian cancer
Peritoneal cancer
Fallopian tube cancer
Malnutrition
Surgery
Gynecological Cancer
Suspected advanced epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 16, 2014