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

Study Overview
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Brief Summary
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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.

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

Conditions
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Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Dietary Supplement: Early post-operative enteral feeding


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early post-operative enteral feeding<br>Standard post-operative care and diet together with early post-operative enteral feeding | Dietary Supplement: Early post-operative enteral feeding<br>* 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.<br>|
| No Intervention: Standard post-operative care and diet<br>Standard post-operative care and diet only | |

What is the study measuring?
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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 | 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 | 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 |  | Until discharge from hospital | 
| Nutritional status 6 weeks after surgery |  | 6 weeks after surgery | 
| Treatment related adverse events |  | End of study | 
| Delay and dose reductions of chemotherapy / quality of life during chemotherapy |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, Ovarian cancer, Peritoneal cancer, Fallopian tube cancer, Malnutrition, Surgery, Gynecological Cancer, Suspected advanced epithelial ovarian cancer