Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000162415
Ethics application status
Approved
Date submitted
5/03/2007
Date registered
9/03/2007
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Specialised nutrition in head and neck cancer surgery
Scientific title
A randomised Phase I/II trial to investigate the effects of immune-modulating nutritional supplements provided perioperatively to non-malnourished patients undergoing surgery for head and neck cancer on postoperative immune status and inflammation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cancer of the oral cavity, pharynx or larynx. 1664 0
Condition category
Condition code
Cancer 1770 1770 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three-arm study:

IMPACT group receives 5 days standard ORAL IMPACT (Novartis, 3 sachets/d, each sachet of 74g contains 3.8g arginine, 0.4 g nucleotides, 1.0 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) preoperatively and standard enteral IMPACT postoperatively commencing as soon as possible, within clinical guidelines, after surgery up to full caloric requirements for 5 days.
Glutamine group receives 5 days oral lutamine (30g/d, Glutaminox, Oxford Nutrition) preoperatively and glutamine enriched (30g/d) standard enteral feed postoperatively commencing as soon as possible, within clinical guidelines, after surgery up to full caloric requirements for 5 days.
.
Intervention code [1] 1630 0
Treatment: Other
Comparator / control treatment
Control group receives standard nutritional therapy, typically no preoperative nutritional supplements and standard postoperative enteral feed.
Control group
Active

Outcomes
Primary outcome [1] 2476 0
Postoperative immune and inflammatory status which includes C-reactive protein, total lymphocytes, CD3, CD4, CD8, immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin (IgA), tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6).
Timepoint [1] 2476 0
Measured on postoperative days 1, 3, 5 and 7
Secondary outcome [1] 4248 0
Postoperative infectious complications
Timepoint [1] 4248 0
Over the first 30 postoperative days.
Secondary outcome [2] 4249 0
Change in total body protein
Timepoint [2] 4249 0
From baseline to postoperative day 10.

Eligibility
Key inclusion criteria
Scheduled for radical resection of cancers of the oral cavity, pharynx and larynx.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if pregnant, diabetic, on immunosuppressants, have had previous wide-field radical radiotherapy for head and neck cancer, or have greater than 10% weight loss.

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)
Allocation is by sequentially numbered sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with randomisation sequence generated by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2007
Actual
11/06/2007
Date of last participant enrolment
Anticipated
Actual
7/12/2007
Date of last data collection
Anticipated
Actual
8/01/2008
Sample size
Target
30
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 488 0
New Zealand
State/province [1] 488 0

Funding & Sponsors
Funding source category [1] 1922 0
Charities/Societies/Foundations
Name [1] 1922 0
Greenlane Research and Education Fund
Country [1] 1922 0
New Zealand
Primary sponsor type
Individual
Name
Dr Mark Izzard
Address
Department of Otolaryngology, Auckland City Hospital, Private Bag 92024, Auckland
Country
New Zealand
Secondary sponsor category [1] 1733 0
Individual
Name [1] 1733 0
Associate Professor Lindsay Plank
Address [1] 1733 0
Department of Surgery, University of Auckland, Private Bag 92019, Auckland
Country [1] 1733 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3576 0
Auckland City Hospital
Ethics committee address [1] 3576 0
Ethics committee country [1] 3576 0
New Zealand
Date submitted for ethics approval [1] 3576 0
Approval date [1] 3576 0
13/02/2007
Ethics approval number [1] 3576 0
NTY/0610/094.

Summary
Brief summary
This is a study of specialised nutrition in people having surgery for head and neck cancer.

Who is it for?
You can join this study if you are undergoing major surgery for head and neck cancer and your doctor thinks you are not malnourished.

Trial details
Participants will be randomly divided into three groups. The different groups receive either:
• preoperatively 5 days of oral IMPACT solution and postoperatively IMPACT enteral feeding. (IMPACT contains a number of supplements that may help the immune system.)
• preoperatively 5 days of oral glutamine supplements and postoperative glutamine enteral feeding. (Glutamine may help the immune system.)
• standard nutritional supplementation which usually involves no preoperative supplements and standard postoperative enteral feeding.

The study looks at the effects of the different regimes. In particular it investigates postoperative immune and inflammatory status measured by blood tests on Days 1, 3, 5 and 7 after surgery.

Standard postoperative care for people undergoing major surgery for head and neck cancer includes intensive nursing and medical care and enteral nutritional support. The trial includes different types of supplements which try and help the immune system. One of the trials uses the supplement IMPACT which contains a number of different supplements and the other uses glutamine. The supplements are given orally before the surgery and enterally after the surgery. The blood test results will provide the foundation for a larger scale study with infectious complications and nutritional status as major endpoints.
Trial website
Trial related presentations / publications
Turnock A, Calder PC, West AL, Izzard M, Morton RP, Plank LD. Perioperative immunonutrition in well-nourished patients undergoing surgery for head and neck cancer: evaluation of inflammatory and immunologic outcomes. Nutrients 2013; 5: 1186-1199.
Public notes

Contacts
Principal investigator
Name 27564 0
Address 27564 0
Country 27564 0
Phone 27564 0
Fax 27564 0
Email 27564 0
Contact person for public queries
Name 10819 0
Associate Professor Lindsay Plank
Address 10819 0
Department of Surgery
University of Auckland
Auckland Hospital Support Building
Park Road
Auckland
Country 10819 0
New Zealand
Phone 10819 0
+64 9 3074935
Fax 10819 0
Email 10819 0
[email protected]
Contact person for scientific queries
Name 1747 0
Dr Mark Izzard
Address 1747 0
Department of Otolaryngology
Auckland City Hospital
Private Bag 92024
Auckland
Country 1747 0
New Zealand
Phone 1747 0
+64 9 6309943 ext 4388
Fax 1747 0
Email 1747 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.