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OpenTrials
Completed

NCT Number: NCT00850772

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

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Wesley Hospital, Auchenflower, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early post-operative enteral feeding

Dietary Supplement

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Need for inotropic medications and intravenous treatment requirements

    Time frame: Until discharge from hospital

  3. Nutritional status 6 weeks after surgery

    Time frame: 6 weeks after surgery

  4. Treatment related adverse events

    Time frame: End of study

  5. Delay and dose reductions of chemotherapy / quality of life during chemotherapy

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Collaborators

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

Registry information

Acronym: OPEN

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2009
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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