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

Fallopian Tube Cancer Clinical Trial

— OPEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850772
• Other study ID #: OPEN
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2009
• Last updated: June 10, 2014
• Start date: January 2009
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

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.

Locations

Country	Name	City	State
Australia	The Wesley Hospital	Auchenflower	Queensland
Australia	Brisbane Private Hospital	Brisbane	Queensland
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Mater Health Services	South Brisbane	Queensland
Australia	Gold Coast Hospital	Southport	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer	Cancer Australia Priority-driven Collaborative Cancer Research Scheme, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Need for inotropic medications and intravenous treatment requirements		Until discharge from hospital	Yes
Secondary	Nutritional status 6 weeks after surgery		6 weeks after surgery	Yes
Secondary	Treatment related adverse events		End of study	Yes
Secondary	Delay and dose reductions of chemotherapy / quality of life during chemotherapy		End of study	Yes