Head and Neck Squamous Cell Cancer
Conditions
Keywords
nutritional status, nutritional intervention, handgrip strength, patient-generated subjective global assessment, chemoradiotherapy, survival
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.
Interventions
BEHAVIORALNutritional 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.
Sponsors
University of Helsinki
University of Eastern Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | 6 months | Nutritional status was assessed by patient-generated subjective global assessment and anthropometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Finland
Outcome results
None listed