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

NCT ID: NCT00850772

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-08-31

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.

Conditions

Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early post-operative enteral feeding

Standard post-operative care and diet together with early post-operative enteral feeding

Group Type: EXPERIMENTAL

Early post-operative enteral feeding

Intervention Type: 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.

Standard post-operative care and diet

Standard post-operative care and diet only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Australia Priority-driven Collaborative Cancer Research Scheme

UNKNOWN

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

Queensland Centre for Gynaecological Cancer

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Obermair, MD FRANZCOG CGO

Role: STUDY_CHAIR

Queensland Centre for Gynaecological Cancer

Locations

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, Australia

Countries

Australia

References

Baker J, Janda M, Graves N, Bauer J, Banks M, Garrett A, Chetty N, Crandon AJ, Land R, Nascimento M, Nicklin JL, Perrin LC, Obermair A. Quality of life after early enteral feeding versus standard care for proven or suspected advanced epithelial ovarian cancer: Results from a randomised trial. Gynecol Oncol. 2015 Jun;137(3):516-22. doi: 10.1016/j.ygyno.2015.03.048. Epub 2015 Mar 28.

Reference Type: DERIVED

PMID: 25827292 (View on PubMed)

Other Identifiers

OPEN

Identifier Type: -

Identifier Source: org_study_id