NCT00850772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 12, 2014

Status Verified

June 1, 2014

Enrollment Period

4.6 years

First QC Date

February 23, 2009

Last Update Submit

June 10, 2014

Conditions

Epithelial Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Keywords

Enteral nutritionOvarian cancerPeritoneal cancerFallopian tube cancerMalnutritionSurgeryGynecological CancerSuspected advanced epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • length of 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

Study Arms (2)

Early post-operative enteral feeding

EXPERIMENTAL

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

Dietary Supplement: Early post-operative enteral feeding

Standard post-operative care and diet

NO INTERVENTION

Standard post-operative care and diet only

Interventions

Early post-operative enteral feedingDIETARY_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.

Early post-operative enteral feeding

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

Brisbane Private Hospital

Brisbane, Queensland, 4000, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Health Services

South Brisbane, Queensland, 4101, Australia

Location

Gold Coast Hospital

Southport, Queensland, 4215, Australia

Location

Related Publications (1)

  • 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.

    PMID: 25827292DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsOvarian NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Andreas Obermair, MD FRANZCOG CGO

    Queensland Centre for Gynaecological Cancer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 12, 2014

Record last verified: 2014-06

Locations

AU(6)