Intensive Nutrition Counselling in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Squamous Cell Cancer

Intervention / Treatment
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* Behavioral: Nutritional counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Individualised on-demand counselling<br>Individualized on-demand counselling group was assigned to receive baseline nutritional counselling, that consisted of one dietetic consultation before (chemo)radiotherapy. During (chemo)radiotherapy on-demand counselling group patients received further counselling only on demand. | |
| Experimental: Intensive nutritional counselling<br>Intensive nutritional counselling consisted of protocolled counselling given by a dietitian once at baseline and on the 2nd and 4th week of treatment and at the end of chemoradiotherapy. | Behavioral: Nutritional counselling<br>* In both study arms, daily estimated energy requirements were calculated from the basal energy requirements according to WHO multiplied by a 1.5 activity factor and protein requirement (g/day) was calculated multiplying ideal body weight (defined as BMI 22) by 1.2 to 1.5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Nutritional status was assessed by patient-generated subjective global assessment and anthropometry. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall survival (OS) is defined as the time interval between the date of the randomization (i.e. at diagnosis) and the date of the last visit or death by any cause. | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional status, nutritional intervention, handgrip strength, patient-generated subjective global assessment, chemoradiotherapy, survival