A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial.

Pressure ulcers represent a major current health problem and cause an important economic impact on the healthcare system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids (HOFA), and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than HOFA, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care. STUDY DESIGN: Cost minimization analysis of the results obtained from a noninferiority, triple-blind, parallel, multicenter, randomized clinical trial. Population attending primary healthcare centers in Andalusia (Spain). STUDY SAMPLE: 831 immobilized patients at risk of suffering pressure ulcers. These persons were included in the study and randomly assigned as follows: 437 to the olive oil group and 394 to the HOFA group. At the end of the follow-up period, the results obtained by the olive oil group were not inferior to those of the HOFA group, and did not exceed the 10% delta limit. The total treatment cost for 16 weeks was €19,758 with HOFAs and €9,566 with olive oil. Overall, the olive oil treatment was €10,192 less costly. It has been concluded the noninferiority of olive oil makes this product an effective alternative for the prevention of pressure ulcers in patients who are immobilized and in a domestic environment. This treatment enables considerable savings in direct costs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01595347. Date: 2011-2013.

Long-term effects of varying consumption of ω3 fatty acids in ear, nose and throat cancer patients: assessment 1 year after radiotherapy.

A prospective 1-year follow-up study in ear, nose, and throat (ENT) cancer patients was carried out one year after radiotherapy to assess the effect of varying consumption of ω3 fatty acid according to whether they consumed more or less than the 50th percentile of ω3 fatty acids. Clinical, analytical, inflammatory (CRP and IL-6), and oxidative variables (TAC, GPx, GST, and SOD) were evaluated. The study comprised 31 patients (87.1% men), with a mean age of 61.3 ± 9.1 years. Hematological variables showed significant differences in the patients with a lower consumption of ω3 fatty acids. A lower mortality and longer survival were found in the group with ω3 fatty acid consumption ≥50th percentile but the differences were not significant. No significant difference was reached in toxicity, inflammation, and oxidative stress markers. The group with ω3 fatty acid consumption <50th percentile significantly experienced more hematological and immune changes.

[Improving the nutritional care of oncology patients - Validation of a multidisciplinary protocol in the Spanish clinical setting]. / Mejorando la atención nutricional del paciente oncológico: validación de un protocolo multidisciplinar en el entorno clínico español.

Introduction: Introduction: malnutrition is a very frequent problem in oncology patients and may have serious repercussions. Adequate nutritional management is cost-effective in terms of health and survival in this population, but it requires multidisciplinary coordination, specific training, and continuous follow-up. Objective: to validate the applicability and efficacy of a multidisciplinary nutritional support protocol in oncology patients. Methods: a multidisciplinary nutritional protocol was developed for oncology patients, with guidelines for screening and assessment of malnutrition, treatment, re-evaluation, and management of side effects, as well as guidance on supplementation and eating patterns. The protocol would be implemented in various clinical centers, collecting data through a structured questionnaire, registering variables before and after implementation. Results: the protocol and its impact were implemented and evaluated in 39 centers. An improvement in nutritional care was observed, evidenced by an earlier initiation of nutritional assessment and an increase in the number of patients receiving adequate care following the protocol implementation. Problems related to inadequate malnutrition coding in the centers, limited resources, and the need for greater interdepartmental collaboration were identified. Conclusions: the conduct of this study provides insights into how the implementation of a multidisciplinary nutritional support protocol can improve the nutritional care received by patients and informs about the main obstacles to adequate implementation.

Introducción: Introducción: la desnutrición es un problema muy frecuente en el paciente oncológico y puede tener graves repercusiones. Un manejo nutricional adecuado es coste-efectivo en términos de salud y supervivencia en esta población, pero requiere de coordinación multidisciplinar, formación específica y seguimiento continuo. Objetivo: validar la aplicabilidad y eficacia de un protocolo multidisciplinar de soporte nutricional en pacientes oncológicos. Métodos: se desarrolló un protocolo nutricional multidisciplinar para pacientes oncológicos, con pautas para el cribado y valoración de la desnutrición, el tratamiento, la reevaluación y la gestión de los efectos secundarios, además de orientaciones sobre suplementación y patrones de alimentación. Se implementaría el protocolo en diversos centros clínicos, recogiendo datos a través de un cuestionario estructurado, registrando variables antes y después de la implementación. Resultados: se implementó y se valoraron el protocolo y su impacto en 39 centros. Se observó una mejoría en la atención nutricional, evidenciada por un inicio más precoz de la valoración nutricional y un aumento en el número de pacientes que recibían atención adecuada tras la implementación del protocolo. Se identificaron problemas relacionados con una inadecuada codificación de la desnutrición en los centros, recursos limitados y la necesidad de mayor colaboración interdepartamental. Conclusiones: la realización de este estudio ofrece información de cómo la implementación de un protocolo multidisciplinar de soporte nutricional puede contribuir a mejorar la atención nutricional que reciben los pacientes e informa de cuáles son los principales obstáculos para una implementación adecuada.

Influence of the microbiome on radiotherapy-induced oral mucositis and its management: A comprehensive review.

Radiation-induced mucositis is the most common, debilitating and painful acute toxicity associated with active treatment in head and neck cancer area, severely affecting more than 65% of patients. Oral microbiota significantly changes during cancer therapy and appears to be involved on its pathophysiology. This review aims to present a comprehensive update of new etiopathogenic factors and treatments that may decrease the incidence of mucositis, mainly modifications of dietary interventions to modify microbiome. Despite advances in recent years, its management is mainly symptomatic opioid-based with variable results on different substances analyzed for its prevention. Immunonutrition seems to play a significant role, particularly the supplementation of compounds such as fatty acids, polyphenols or selected probiotics have shown to promote commensal bacteria diversity and reduced incidence of ulcerative mucositis. Modification of the microbiome is a promising preventive treatment for mucositis although its evidence is still scarce. Large studies are needed to demonstrate the efficacy of interventions on microbiome and its clinical impact on radiation-induced mucositis.

Role of radiotherapy in the treatment of metastatic head and neck cancer.

In metastatic or locally advanced head and neck tumors that present in frail patients or after chemotherapy progression, radiotherapy is normally used as a palliative treatment, with a high rate of symptom palliation and improvement in quality of life. However, there is controversy about what the optimal regimen is. Moreover, despite the poor prognosis of metastatic head and neck cancer, different retrospective studies have shown that a minority of patients with oligometastatic disease experience prolonged disease-free survival after adding curative radiotherapy treatment to the metastatic disease and/or primary tumor. Different retrospective studies have identified clinical prognostic factors that may be used to select candidate patients with metastatic head and neck cancer for a radical approach with radiotherapy. The purpose of this manuscript is to review the role of radiotherapy in metastatic and locally advanced head and neck tumors.

Adherence and tolerance as key in brake on weight loss in cancer patients with nutritional risk after intervention with a high calorie nutritional and specific hyperproteic supplement / Adherencia y tolerancia como claves en la detención de la pérdida de peso en pacientes oncológicos sometidos a radioterapia mediante una estrategia de suplementación precoz con una fórmula enteral hipercalórica e hiperproteica específica

Background: In patients with nutritional risk, the European Society for Clinical Nutrition and Metabolism (ESPEN) recommends nutritional supplements during cancer treatment to prevent weight loss. Objectives: Our goal is to determine the acceptability, compliance and tolerance of a hyperproteic, high-calorie, omega-3 enriched supplement in cancer patients. Methods: Unicentric, prospective observational study in cancer patients with hyperproteic, high-calorie, rich in omega 3 and low volume nutritional supplement. Thirty patients with malnutrition or risk of malnutrition were included. Supplementation lasted six days. Compliance (packaging used), acceptability (Madrid scale), anthropometric variables and gastrointestinal adverse events (AEs) were evaluated. Results: Seventy per cent were men, with an average age of 60 years (range 32-79), with lung (43.3%), ENT (26.7%) and breast neoplasms (13.3%), stage III-IV (56.7%), and treated with radiotherapy (93.3%), chemotherapy (60%) and surgery (16.7%). The product was accepted by all patients. A compliance rate of 100% was observed. Gastrointestinal AE (grade II) related to the supplement was observed in two patients (6.7%). Both subjects had previous gastrointestinal diseases. The median weight, body mass index (BMI) and protein intake increased during supplementation (0.2 kg, 0.1 kg/m2 and 6.2 g). No differences were observed regarding calorie, fat and carbohydrates intake. Conclusion: The high acceptance and compliance with the specific nutritional supplement was associated with an improved nutritional status for cancer patients, and reversed the weight loss without severe gastrointestinal problems, or producing intake displacement.

Introducción: en pacientes con riesgo nutricional, la Sociedad Europea de Clínica y Metabolismo (ESPEN) y Parenteral recomienda suplementos nutricionales durante el tratamiento oncológico para prevenir la pérdida de peso involuntaria. Objetivos: nuestro objetivo es conocer el cumplimiento, la aceptabilidad y la tolerancia de un suplemento hiperproteico, hipercalórico, rico en omega 3 en pacientes oncológicos. Métodos: estudio unicéntrico, observacional y prospectivo en pacientes oncológicos con un suplemento nutricional hiperproteico, hipercalórico, rico en omega 3 y de bajo volumen. Fueron incluidos 30 pacientes con desnutrición o en riesgo de desnutrición. La suplementación duró seis días. Se evaluaron el cumplimiento (envases utilizado), la aceptabilidad (escala Madrid), las variables antropométricas y los acontecimientos adversos (AA) gastrointestinales. Resultados: el 70% fueron hombres, con una edad media de 60 años (rango: 32 a 79) y con neoplasias de pulmón (43,3%), ORL (26,7%) y mama (13,3%), en estadio III-IV (56,7%), tratados con radioterapia (93,3%), quimioterapia (60%) y cirugía (16,7%). El producto fue aceptado por todos los pacientes. Se observó un cumplimiento del 100%. En dos pacientes (6,7%) se observaron AA gastrointestinales (grado II) relacionados con el suplemento; ambos sujetos presentaban patologías gastrointestinales previas. La mediana del peso, índice de masa corporal (IMC) y proteínas ingeridas aumentó durante la suplementación (0,2 kg, 0,1 kg/m2 y 6,2 g). No se observaron diferencias respecto a la ingesta de calorías, lípidos y carbohidratos. Conclusión: la elevada aceptación y cumplimiento del suplemento nutricional específico se asoció con la mejora nutricional de los pacientes oncológicos, pues revirtió la pérdida de peso, sin presentar problemas gastrointestinales severos ni producir desplazamiento de la ingesta.

Potential advantages of volumetric arc therapy in head and neck cancer.

BACKGROUND: Intensity-modulated radiation therapy (IMRT) uses solid compensators or multileaf collimators to modulate the intensity of radiation in each field, delivering highly conformal dose distributions. This technique allows treating volumes with concave shapes when the target is close to a critical structure. The movement of multileaf collimator under computer control can modulate the dose in 3 main ways: IMRT with static field with segments, IMRT with dynamic delivery, and IMRT rotational therapy. Volumetric modulated arc therapy (VMAT) is a novel radiation technique that creates conformal distributions with variable gantry speed, dynamic movements of multileaf collimator, and variations in dose rate. The purpose of this study was to review the basis of VMAT, highlighting the differences with other IMRT techniques.

Advances in the treatment of prostate cancer with radiotherapy.

INTRODUCTION: Prognosis of prostate cancer has improved as a result of the combination with androgen deprivation therapy and the increase of radiation dose. However, a high number of prostate cancer patients will develop biochemical recurrence; therefore a research effort to increase the control of the tumour in these patients is necessary. METHODS: To increase the therapeutic ratio (the index between cytotoxic effects and normal tissue complications with a certain dose of radiation), different new strategies described in the literature have been reviewed. RESULTS: There are several strategies that may increase the efficacy of radiotherapy to treat prostate cancer. First is based on physics and technology, and second based on biology. DISCUSSION: Technical advances in radiotherapy allow intensification of radiation through escalation of the dose or in combination with chemotherapy. Furthermore, targeting specific molecular dysregulated pathways in the tumour will increase the effects of radiation specifically in tumour cells. Hopefully, these strategies will result in increased rates of tumour control in all prognostic groups, especially in high risk tumours and a subgroup of patients with intermediate risk tumours, minimizing treatment morbidity and increasing the therapeutic ratio of radiotherapy.

Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.

UNLABELLED: Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances. METHODS AND DESIGN: Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers. RESULTS: The follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded. DISCUSSION: The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome. TRIAL REGISTRATION: Clinicaltrials.gov NCT01595347.

Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.

BACKGROUND: Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. METHODS/DESIGN: The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. DISCUSSION: The regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01595347.