Adult patients (18 years or older) with a de novo diagnosis of solid tumour, regardless of stage, who started chemotherapy at least 15 months previously, were included in the study. Those who, for cultural or cognitive reasons, had difficulty understanding the study aims were excluded. All patients who met the inclusion and exclusion criteria were included consecutively; therefore, no sample size calculation was needed or performed.
The study protocol was carried out in accordance with the provisions of the Declaration of Helsinki and was approved by the local Clinical Research Ethics Committee. All patients included in the study gave their written informed consent to participate.
In this prospective study, the nutritional care model for cancer patients differentiates two groups of patients according to the location of the tumour and its impact on nutritional status: group 1 includes patients with high-risk tumours (cancers of the head and neck and of the upper digestive tract, oesophagus, stomach, pancreas or bile duct); group 2 contains patients with low nutritional risk tumours and all other malignancies.
In the course of the study, the group 1 patients were referred directly for nutrition consultation, either after presentation of their data to the corresponding oncology committee or during the admission in which they were diagnosed with the tumour pathology. The “Individualised nutritional care programme” was then launched, involving nutritional assessment, intervention and vigilant follow-up. This process begins with a complete nutritional assessment of food intake and symptoms that could affect nutritional status, following international guidelines of The European Society for Clinical Nutrition and Metabolism (ESPEN) on nutritional support for cancer patients . The type and degree of malnutrition observed determines the nutritional intervention stipulated, ranging from nutritional advice to specialised nutritional support, as recommended in the ESPEN guidelines .
A vigilant, individualised monitoring plan was then established, with periodic reviews to assess the patient’s treatment adherence, tolerance and efficacy.
The group 2 patients received a nutritional screening at their first consultation with the oncologist or at the day-patient hospital pharmacy consultation, before starting chemotherapy. Patients whose screening results were positive, showing them to be at risk of malnutrition, were assigned a degree of malnutrition, according to the patient-generated subjective global assessment (PG-SGA), a validated method that produces the following classifications: A) Normally nourished; B) At nutritional risk or presenting moderate malnutrition; C) Presenting severe malnutrition . Patients classed as being at risk of malnutrition, with moderate malnutrition or with severe malnutrition (B/C) were referred to the nutrition consultation, and the “Individualised nutritional care programme” was initiated.
Group 2 patients whose screening results were negative and who, therefore, were not considered to be at nutritional risk, received periodic re-evaluations, with continuous monitoring in each treatment cycle or during the perioperative period. All the patients included in this study were given nutritional recommendations on request, whether or not nutritional risk was observed. The procedure shown in Fig. 1 was followed.
The screening process was conducted using the Nutriscore instrument . This nutritional screening test, which has been validated for use in outpatient cancer patients, identifies involuntary weight loss in the last three months, decreased appetite, tumour location and cancer treatment received. Patients are assumed to be at nutritional risk if the Nutriscore result is 5 points or more (out of the maximum 9 points). When the score is less than 5, the patient does not present nutritional risk.
Each patient’s body weight was recorded at different times during the nutritional care, and was defined as follows:
Normal weight (NW)
Weight during the last three months, as reported by the patient.
Initial weight (IW)
Weight when the nutritional care model was first applied. Weight loss is quantified as NW-IW/NW*100. This value is expressed as the percentage of weight loss (%WL) on first application of the nutritional care model.
Chemotherapy start weight (CSW)
Weight at the start of chemotherapy.
Chemotherapy end weight (CEW)
Weight on concluding chemotherapy.
The effectiveness of the nutritional care protocol was evaluated by reference to the percentage of weight gained (%WG) or maintained (%WM) at the end of the treatment, quantified as the difference between the patient’s weight on concluding chemotherapy and the initial weight recorded.
A weight loss of 2% or more was considered significant. Smaller losses were not taken into consideration, since they might reflect intra and interpersonal variability when the weight was recorded (for example, shortly after eating or fasting, or differences in the weight of clothing).
The nutritional care protocol was considered to have been applied at an early stage when the patient was first attended in this respect before starting chemotherapy or during the first seven days thereafter.
Descriptive analysis was performed using measures of central tendency, dispersion and position for the quantitative variables and of frequency distribution for the qualitative ones. Differences between two measurements were evaluated by the Wilcoxon rank test or the Mann-Whitney U test for independent samples referring to quantitative variables. Average differences between two groups were evaluated by the chi-square test. In all cases, statistical significance was assumed at p < 0.05.