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Trial registered on ANZCTR


Registration number
ACTRN12618001385235
Ethics application status
Approved
Date submitted
26/10/2017
Date registered
17/08/2018
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Extended Tube Feeding in Patients with Oesophageal Cancer - Pilot
Scientific title
Post-Operative Extended Enteral Nutrition in Patients with Oesophageal Cancer requiring Oesophagectomy – A Pilot Study
Secondary ID [1] 293217 0
Nil
Universal Trial Number (UTN)
is U1111-1204-2540
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal Cancer 305230 0
Condition category
Condition code
Cancer 304534 304534 0 0
Oesophageal (gullet)
Diet and Nutrition 308131 308131 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be fed enterally for a 12 weeks (intervention) with a nutritional supplement (such as Nutrison Protein Plus MultiFibre) providing 20kCal/kg energy and 1g/kg Protein per day as an overnight feed to supplement high protein, high energy oral diet. The feeding tube will be placed during surgery and the ward dietitian will commence the feeding regimen. Patients will be provided with a high energy, high protein diet of the appropriate texture while inpatients and the dietitian will provide education on how to optimise their oral intake at home prior to discharge. This is the current usual care for all patients after oesophagectomy.
Intervention code [1] 299474 0
Treatment: Other
Comparator / control treatment
Participants in this study will be fed enterally for a period of 6 weeks (which is current usual care) with a nutritional supplement (such as Nutrison Protein Plus MultiFibre) providing 20kCal/kg energy and 1g/kg Protein per day as an overnight feed to supplement high protein, high energy oral diet. This is the current usual care for patients who have undergone oesophageal cancer. Previously all patients were receiving 1500kCal per day via jejunal feeding, however due to varying body weights of patients and different requirements the current usual care is now enteral feeding of 20kcal/day.
Control group
Active

Outcomes
Primary outcome [1] 303772 0
Percentage weight change. Weight will be measured prior to admission and at the time points indicated using a SECA 676 digital scale that measures up to 360kg in 50g increment. Difference in weight (kg) will be assessed to provide % weight change.
Timepoint [1] 303772 0
3 and 6 months
Secondary outcome [1] 340114 0
Quality of Life - using the QLQ-C30 and oesophageal cancer specific addition OES-18.
Timepoint [1] 340114 0
3 and 6 months
Secondary outcome [2] 340115 0
Skeletal Muscle Index assessed via DEXA
Timepoint [2] 340115 0
6 months
Secondary outcome [3] 350719 0
Malnutrition Status - assessed by Subjective Global Assessment tool
Timepoint [3] 350719 0
3 and 6 Months
Secondary outcome [4] 350720 0
Energy Intake (kJ) - assessed via 24 hr recall
Timepoint [4] 350720 0
3 and 6 Months
Secondary outcome [5] 350721 0
Serum Albumin,
Timepoint [5] 350721 0
Baseline and 6 Months
Secondary outcome [6] 350722 0
Oral intake - dietitian assessment of general oral intake and progression from puree to full diet.
Timepoint [6] 350722 0
6 weeks, 3 months, 6 months
Secondary outcome [7] 350723 0
Assessment of functional status using the 6 minute walk test
Timepoint [7] 350723 0
3 and 6 months
Secondary outcome [8] 350739 0
Protein Intake, assessed by dietitian from 24 hr recall
Timepoint [8] 350739 0
3 and 6 months
Secondary outcome [9] 350740 0
Serum CMP
Timepoint [9] 350740 0
Baseline and 6 months
Secondary outcome [10] 350741 0
Serum Haemoglobin
Timepoint [10] 350741 0
Baseline and 6 months
Secondary outcome [11] 350742 0
Serum Zn
Timepoint [11] 350742 0
Baseline and 6 months
Secondary outcome [12] 350743 0
Serum Selenium
Timepoint [12] 350743 0
Baseline and 6 months
Secondary outcome [13] 350744 0
Serum B12
Timepoint [13] 350744 0
Baseline and 6 months
Secondary outcome [14] 350745 0
Serum folate,
Timepoint [14] 350745 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Patients with oesophageal cancer undergoing curative surgery at the John Hunter Hospital, NSW (ie patients undergoing surgery with a view to cure cancer rather than for palliative or short term treatment).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having non-curative surgery
Patients being discharged to another facility other than home.
Women who are pregnant would not generally be candidates for oesophageal cancer so would not be participants, additionally as an adult hospital, all patients will be aged > 18 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/08/2018
Actual
17/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9251 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 17913 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296222 0
Charities/Societies/Foundations
Name [1] 296222 0
Hunter Cancer Research Alliance
Country [1] 296222 0
Australia
Primary sponsor type
Individual
Name
Mrs Emma McNamara
Address
Nutrition and Dietetics
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 295134 0
Individual
Name [1] 295134 0
Dr Vanessa Wills
Address [1] 295134 0
Division of Surgery
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country [1] 295134 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297461 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297461 0
Ethics committee country [1] 297461 0
Australia
Date submitted for ethics approval [1] 297461 0
30/11/2017
Approval date [1] 297461 0
07/06/2018
Ethics approval number [1] 297461 0
17/12/13/4.05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74110 0
Dr Emma McNamara
Address 74110 0
Nutrition and Dietetics,
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 74110 0
Australia
Phone 74110 0
+61 2 49213685
Fax 74110 0
Email 74110 0
emma.mcnamara@health.nsw.gov.au
Contact person for public queries
Name 74111 0
Emma McNamara
Address 74111 0
Nutrition and Dietetics,
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 74111 0
Australia
Phone 74111 0
+61 2 49213685
Fax 74111 0
Email 74111 0
Emma.McNamara@health.nsw.gov.au
Contact person for scientific queries
Name 74112 0
Emma McNamara
Address 74112 0
Nutrition and Dietetics,
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 74112 0
Australia
Phone 74112 0
+61 2 49213685
Fax 74112 0
Email 74112 0
Emma.McNamara@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3353Study protocol    372763-(Uploaded-02-08-2019-12-52-30)-Study-related document.docx
3354Statistical analysis plan  emma.mcnamara@health.nsw.gov.au
3355Informed consent form  emma.mcnamara@health.nsw.gov.au
3356Ethical approval  emma.mcnamara@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.