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

Phase 3

Completed

• Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
• Interventions: Dietary Supplement: Early post-operative enteral feeding

• Registration Number: NCT00850772
• Lead Sponsor: Queensland Centre for Gynaecological Cancer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early post-operative enteral feeding	Early post-operative enteral feeding	Standard post-operative care and diet together with early post-operative enteral feeding

Primary Outcome Measures

Name	Time	Method
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life	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 Outcome Measures

Name	Time	Method
length of stay	Until discharge from hospital	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	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

Trial Locations

Locations (6)

The Wesley Hospital; 🇦🇺 Auchenflower, Queensland, Australia

Mater Health Services; 🇦🇺 South Brisbane, Queensland, Australia

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Queensland, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Gold Coast Hospital; 🇦🇺 Southport, Queensland, Australia

Brisbane Private Hospital; 🇦🇺 Brisbane, Queensland, Australia