Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer (OPEN)
This study is ongoing, but not recruiting participants.
Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborators:
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
The University of Queensland
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00850772
First received: February 23, 2009
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Dietary Supplement: Early post-operative enteral feeding |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Queensland Centre for Gynaecological Cancer:
Primary Outcome Measures:
- Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life [ Time Frame: End of study ] [ Designated as safety issue: No ]
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:
- length of stay [ Time Frame: Until discharge from hospital ] [ Designated as safety issue: Yes ]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 [ Time Frame: Until discharge from hospital ] [ Designated as safety issue: Yes ]
- Nutritional status 6 weeks after surgery [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]
- Treatment related adverse events [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
- Delay and dose reductions of chemotherapy / quality of life during chemotherapy [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early post-operative enteral feeding
Standard post-operative care and diet together with early post-operative enteral feeding
|
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.
|
|
No Intervention: Standard post-operative care and diet
Standard post-operative care and diet only
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850772
Locations
| Australia, Queensland | |
| The Wesley Hospital | |
| Auchenflower, Queensland, Australia, 4066 | |
| Brisbane Private Hospital | |
| Brisbane, Queensland, Australia, 4000 | |
| Greenslopes Private Hospital | |
| Greenslopes, Queensland, Australia, 4120 | |
| Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Mater Health Services | |
| South Brisbane, Queensland, Australia, 4101 | |
| Gold Coast Hospital | |
| Southport, Queensland, Australia, 4215 | |
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Cancer Australia Priority-driven Collaborative Cancer Research Scheme
The University of Queensland
Investigators
| Study Chair: | Andreas Obermair, MD FRANZCOG CGO | Queensland Centre for Gynaecological Cancer |
More Information
No publications provided
| Responsible Party: | Queensland Centre for Gynaecological Cancer |
| ClinicalTrials.gov Identifier: | NCT00850772 History of Changes |
| Other Study ID Numbers: | OPEN |
| Study First Received: | February 23, 2009 |
| Last Updated: | April 22, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council |
Keywords provided by Queensland Centre for Gynaecological Cancer:
|
Enteral nutrition Ovarian cancer Peritoneal cancer Fallopian tube cancer |
Malnutrition Surgery Gynecological Cancer Suspected advanced epithelial ovarian cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013