Spots Global Cancer Trial Database for Intensive Nutrition Counselling in Patients With Head and Neck Cancer

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Trial Identification

Brief Title: Intensive Nutrition Counselling in Patients With Head and Neck Cancer

Official Title: An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy

Study ID: NCT02159508

Conditions

Head and Neck Squamous Cell Cancer

Interventions

Nutritional counselling

Study Description

Brief Summary: 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.

Detailed Description: * 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.