Intensive Nutrition Counselling in Patients With Head and Neck Cancer

Not Applicable

• Conditions: Head and Neck Squamous Cell Cancer
• Interventions: Behavioral: Nutritional counselling

• Registration Number: NCT02159508
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2014-04-29
• Status Verified: 2014-05
• Study First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Study First Posted: 2014-06-10
• Last Update Posted: 2014-06-10
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive nutritional counselling	Nutritional counselling	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.

Primary Outcome Measures

Name	Time	Method
Nutritional status	6 months	Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.

Secondary Outcome Measures

Name	Time	Method
Survival	5 year	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.

Trial Locations

Locations (1)

Department of Otolaryngology - Head & Neck Surgery, Helsinki University Central Hospital and University of Helsinki; 🇫🇮 Helsinki, HUS, Finland