This trial is active, not recruiting.

Condition head and neck squamous cell cancer
Treatment nutritional counselling
Sponsor Helsinki University Central Hospital
Collaborator Helsinki University
Start date November 2007
End date December 2014
Trial size 65 participants
Trial identifier NCT02159508, 322-E9-05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(No Intervention)
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.
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.
nutritional counselling
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.

Primary Outcomes

Nutritional status
time frame: 6 months

Secondary Outcomes

time frame: 5 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.