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

Queensland Centre for Gynaecological Cancer

Status and phase

Completed

Phase 3

Conditions

Epithelial Ovarian Cancer

Peritoneal Cancer

Fallopian Tube Cancer

Treatments

Dietary Supplement: Early post-operative enteral feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT00850772

OPEN

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.