Intensive Nutrition Counselling in Patients With Head and Neck Cancer
An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy
The purpose of this study is to assess the effect of a pre-planned patient-adjusted
intensive nutritional counselling given by a dietitian several times during
(chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in
the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck
squamous cell cancer.
- A sample size of 102 patients was identified to achieve 30% reduction in prevalence of
malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p <
0.05), 90% power. The second calculation was for a sample size of 88 patients for 30%
reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the
significance value 5% (p<0.05), 85% power and effect size 70%. Based on these numbers,
our aim is to recruit 100 patients, with the assumption that 12% patients would be lost
to follow up.
- Randomization will be performed by the minimization procedure with the Minim Program®
(http://www-users.york.ac.uk/~mb55/guide/randsery.htm). The allocation will be done
according to the following criteria: 1) Stage I-II vs. Stage III-IV; 2) age <65 vs.
>=65 year; 3) Body Mass Index <20 vs. >=20 kg/m2 and 4) tumour location (oral
cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx).
- Adverse events of chemoradiotherapy will be classified according to the National Cancer
Institute Common Terminology Criteria for Adverse Events-3.0 (CTCAE v3.0)
- Nutritional status will be assessed by patient-generated subjective global assessment,
nutritional risk screening-2002, upper-arm anthropometry (MAC, triceps skinfold
thickness, MAMA), Bio-impedance, hand grip strength and weight loss.
- Survival: overall survival, disease-specific survival and disease-free survival are
Head and Neck Squamous Cell Cancer
nutritional status, nutritional intervention, handgrip strength, patient-generated subjective global assessment, chemoradiotherapy, survival
Helsinki University Central Hospital
Helsinki University Central Hospital, Helsinki University, University of Eastern Finland
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