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Trial registered on ANZCTR


Registration number
ACTRN12617001248358p
Ethics application status
Not yet submitted
Date submitted
17/08/2017
Date registered
28/08/2017
Date last updated
28/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 fatty acids to improve outcome for patients with head and neck cancer undergoing chemoradiotherapy
Scientific title
EPA and DHA as adjuvant therapy to improve outcome for patients with head and neck cancer undergoing chemoradiotherapy
Secondary ID [1] 292682 0
Nil
Universal Trial Number (UTN)
U1111-1200-9343
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head and neck cancer 304433 0
Condition category
Condition code
Diet and Nutrition 303762 303762 0 0
Other diet and nutrition disorders
Cancer 303836 303836 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SupportanTM group
Two x 200 ml Supportan daily (200ml contains: 300 kcal, 20 g protein and 1.42 g EPA/DHA). This is a liquid product supplied between meal times. If participants are unable to meet their nutrition needs with oral intake and 400ml of Supportan™ per day they will also be offered Fortisip/Ensure powder in order to meet their nutrition requirements. The nutritional adequacy will be determined by the oncologists and oncology dietitians who are part of the research team.
Standard of care nutritional group (control)
If supplementation is required Ensure powder or Fortisip powder will be prescribed, as determined by the Dietitian. Instructions will be given to mix the formula to a 1.5kcal/ml solution. Quantity will be determined based on need (as described above).
The intervention is seven weeks long. Diet recalls and twice weekly compliance survey will determine who is following the intervention

Intervention code [1] 298916 0
Treatment: Other
Comparator / control treatment
Standard of care nutritional group (control)
If supplementation is required Ensure powder or Fortisip powder will be prescribed, as determined by the Dietitian. Instructions will be given to mix the formula to a 1.5kcal/ml solution.
Control group
Active

Outcomes
Primary outcome [1] 303132 0
weight loss (measurement taken by dietitian, according to ISAK protocol)
Timepoint [1] 303132 0
7 weeks post the intervention start
Secondary outcome [1] 337985 0
Lean body mass (Assessed by DEXA machine)
Timepoint [1] 337985 0
7 weeks post intervention start
Secondary outcome [2] 337986 0
Inflammation biomarkers
The following will be measured at baseline and seven weeks:
• CRP, TNFa and IL-6 will be measured as markers of the inflammatory response.
• Circulating levels of TNFa and IL-6 will be measured by standard ELISA kits.
• CRP to albumin ratios will be assessed (LabPlus).

Timepoint [2] 337986 0
7 weeks post intervention start
Secondary outcome [3] 337987 0
quality of life
The following will be measured at baseline and seven weeks:
• QoL (EORTC-QLQ-C30),
Timepoint [3] 337987 0
7 weeks post intervention start
Secondary outcome [4] 337988 0
grip strength (hand dynamometer)
Timepoint [4] 337988 0
7 weeks post intervention start
Secondary outcome [5] 338219 0
Differential gene expression (TNFa, IL6 and IL1),
Timepoint [5] 338219 0
Baseline only
Secondary outcome [6] 338220 0
SNP genotyping (e.g. TNF a 308 A rs1800629, TNF a 857 T rs1799724, TNF a 863 A rs1800630, 1031 C rs1799964, IL 6 rs2069837)
Timepoint [6] 338220 0
Baseline only

Eligibility
Key inclusion criteria
• Histologically confirmed head and neck carcinoma
• Intended for radical concurrent chemo-radiotherapy treatment
• 60-70Gy in 30-35 fractions radiotherapy
• Weekly carboplatin or three weekly cisplatin
• Age >16 y
• Written informed consent.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or lactating
• Uncontrolled diabetes requiring insulin or oral hypoglycemic medication
• Severe comorbidities (major gastrointestinal surgery or disease, autoimmune, renal, cardiac, respiratory, or severe hepatic disease)
• Morbidly obese
• Previous chemo-radiotherapy treatment
• Metastatic disease identified prior to radiotherapy
• Using medication that could modulate metabolism or body weight, in particular high-dose steroids or fish oil supplementation)

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)
Participants will be centrally randomised by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Weight loss for head and neck cancer patients undergoing 7 weeks chemo-radiotherapy during 2016 at Auckland City Hospital was 6.2 kg (SD 3.9 kg). We hypothesise that Supportan supplementation will reduce this weight loss by 50%. To detect this difference in weight loss (at the 5% level) and allowing for a 10% patient withdrawal rate will require 40 patients per group (at 90% power).

The results will be analysed as the mean difference between intervention and control groups.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9155 0
New Zealand
State/province [1] 9155 0
Auckland

Funding & Sponsors
Funding source category [1] 297323 0
Government body
Name [1] 297323 0
Auckland Medical Research Foundation
Address [1] 297323 0
Auckland Medical Research Foundation
Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148
Country [1] 297323 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Science
85 Park Road
Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 296296 0
None
Name [1] 296296 0
Address [1] 296296 0
Country [1] 296296 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298426 0
Health and Disability Ethical Committee
Ethics committee address [1] 298426 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298426 0
New Zealand
Date submitted for ethics approval [1] 298426 0
01/09/2017
Approval date [1] 298426 0
Ethics approval number [1] 298426 0

Summary
Brief summary
HNC patients attending Auckland Hospital for concurrent chemotherapy and radiotherapy will be randomised to an EPA and DHA-containing nutritional supplement (SupportanTM) for seven weeks or to standard care. Follow-up will occur weekly. Baseline and post intervention measures will be taken, and include body weight (taken weekly), circulating CRP, TNFa, IL-6, albumin, blood cell EPA/DHA, differential gene expression (TNFa, IL6 and IL1), SNP genotyping (e.g. TNF a 308 A rs1800629, TNF a 857 T rs1799724, TNF a 863 A rs1800630, 1031 C rs1799964, IL 6 rs2069837), malnutrition screening, body composition (dual-energy X-ray absorptiometry), grip strength, quality of life (EORTC-QLQ-C30, C35), food diaries and adherence to nutritional supplement (documented weekly throughout the trial). The primary outcome (weight at 7 weeks) will be compared between groups using an analysis of covariance adjusting for baseline weight and sex.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77042 0
Dr Andrea Braakhuis
Address 77042 0
Dr Andrea Braakhuis
The University of Auckland
Faculty of Medical and Health Science
85 Park Road,
Grafton, Auckland 1142
Country 77042 0
New Zealand
Phone 77042 0
+64 7 373 7599 Ext 86251
Fax 77042 0
Email 77042 0
a.braakhuis@auckland.ac.nz
Contact person for public queries
Name 77043 0
Dr Andrea Braakhuis
Address 77043 0
Dr Andrea Braakhuis
The University of Auckland
Faculty of Medical and Health Science
85 Park Road,
Grafton, Auckland 1142
Country 77043 0
New Zealand
Phone 77043 0
+64 7 373 7599 Ext 86251
Fax 77043 0
Email 77043 0
a.braakhuis@auckland.ac.nz
Contact person for scientific queries
Name 77044 0
Dr Andrea Braakhuis
Address 77044 0
Dr Andrea Braakhuis
The University of Auckland
Faculty of Medical and Health Science
85 Park Road,
Grafton, Auckland, 1142
Country 77044 0
New Zealand
Phone 77044 0
+64 7 373 7599 Ext 86251
Fax 77044 0
Email 77044 0
a.braakhuis@auckland.ac.nz

No data has been provided for results reporting
Summary results
Not applicable