Intensive Nutrition Counselling in Patients With Head and Neck Cancer
Intensive Nutrition Counselling in Patients With Head and Neck Cancer
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
 calculated.
Inclusion Criteria:

 -  Clinical diagnosis of primary locally advanced squamous cell carcinoma of the oral
 cavity, pharynx, nasopharynx or larynx

 Exclusion Criteria:

 -  renal function impairment

 -  liver insufficiency

 -  heart failure

 -  pulmonal impairment

 -  Chronic obstructive pulmonary disease

 -  cognitive impairment

 -  previous cancer in any location

 -  terminal stage