None listed
Conditions
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.
Interventions
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 ca
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
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
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)
Outcome results
None listed