Epithelial Ovarian CancerPhase 3OPENNCT00850772
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
A Phase 3 study testing Early post-operative enteral feeding in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Queensland Centre for Gynaecological Cancer at 6 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Early post-operative enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 6 sitesAustralia
- Study dates
- Jan 2009to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
The Wesley Hospital
Auchenflower, Queensland, 4066
Brisbane Private Hospital
Brisbane, Queensland, 4000
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Mater Health Services
South Brisbane, Queensland, 4101
Gold Coast Hospital
Southport, Queensland, 4215
About this study
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.
- Being tested
- Early post-operative enteral feeding
- Keywords
- Enteral nutrition, Ovarian cancer, Peritoneal cancer, Fallopian tube cancer, Malnutrition, Surgery, Gynecological Cancer, Suspected advanced epithelial ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Early post-operative enteral feeding | Experimental | Standard post-operative care and diet together with early post-operative enteral feeding Receives: Dietary Supplement: Early post-operative enteral feeding |
| Standard post-operative care and diet | No intervention | Standard post-operative care and diet only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of study
Secondary outcomes (5)
length of stay
Length of stay in an intensive care unit or high dependency unit and overall length of hospital stay.
Measured: Until discharge from hospital
Need for inotropic medications and intravenous treatment requirements
Measured: Until discharge from hospital
Nutritional status 6 weeks after surgery
Measured: 6 weeks after surgery
Treatment related adverse events
Measured: End of study
Delay and dose reductions of chemotherapy / quality of life during chemotherapy
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Cancer Australia Priority-driven Collaborative Cancer Research Scheme, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, MD FRANZCOG CGO, Study chair, Queensland Centre for Gynaecological Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850772
- Sponsor's protocol ID
- OPEN
- Acronym
- OPEN
- Status last verified
- Jun 2014
- First submitted
- 23 Feb 2009
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25827292
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00850772
- Acronym / sponsor ID
- OPEN / OPEN
- Keywords
- Enteral nutrition, Ovarian cancer, Peritoneal cancer, Fallopian tube cancer, Malnutrition, Surgery, Gynecological Cancer, Suspected advanced epithelial ovarian cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Cancer Australia Priority-driven Collaborative Cancer Research Scheme, The University of Queensland
- Study start
- Jan 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early post-operative enteral feeding | Experimental | Dietary Supplement: Early post-operative enteral feedingStandard post-operative care and diet together with early post-operative enteral feeding |
| Standard post-operative care and diet | No intervention | –Standard post-operative care and diet only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early post-operative enteral feedingDuring 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. | Dietary supplement | Early post-operative enteral feeding |
Primary outcome
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
Time frame: End of study
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
5 secondary outcomes
length of stay
Time frame: Until discharge from hospital
Need for inotropic medications and intravenous treatment requirements
Time frame: Until discharge from hospital
Nutritional status 6 weeks after surgery
Time frame: 6 weeks after surgery
Treatment related adverse events
Time frame: End of study
Delay and dose reductions of chemotherapy / quality of life during chemotherapy
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
- Derived from this study: PubMed 25827292Baker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Obermair, MD FRANZCOG CGO study chair
Queensland Centre for Gynaecological Cancer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early post-operative enteral feeding in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Queensland Centre for Gynaecological Cancer at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2014.