Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study).

BACKGROUND: Advances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema, depression, anxiety, sexual dysfunction, malnutrition, and sarcopenia, that negatively impact their quality of life. PRIMARY OBJECTIVE: To assess the impact on self-perceived quality of life of systematic screening and early treatment of lower limb lymphedema, anxiety and depression, sexual dysfunction, and sarcopenia and malnutrition compared with standard practice. STUDY HYPOTHESIS: Systematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life. TRIAL DESIGN: This prospective clinical trial will randomize candidates for surgery to either standard of care or systematic screening every 2 months for 2 years. Quality of life data will be collected every 4 months. After randomization, patients in the control group will follow standard usual care. Their screening scales will not be considered. In the experimental group, positive screenings will generate an alert to the physician, and patients will be referred to the corresponding specific area (rehabilitation unit, psycho-oncology unit, sexual health unit, or nutrition unit). MAJOR INCLUSION AND XCLUSION CRITERIA: Patients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included. PRIMARY ENDPOINT: Self-reported quality of life questionnaire score. SAMPLE SIZE: 168 patients will be randomized to detect a difference of 6 points in the questionnaires. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Study completion is estimated for January 2026 and the results will be presented in May 2026. TRIAL REGISTRATION NUMBER: NCT05918770.

Compliance with a high-protein and energy-dense oral nutritional supplement in patients with disease-related malnutrition: a randomized open-label crossover trial.

Introduction: Patient compliance with oral nutritional supplements (ONS) is not optimal for meeting energy and nutritional requirements in a high proportion of patients with disease-related malnutrition (DRM). Energy density or prescribed volume of ONS may impact compliance. Methods: A randomized, open-label crossover trial was conducted in outpatients with DRM to compare compliance with a high energy-dense ONS (edONS, 2.4 kcal/mL) and a reference ONS (heONS, 2.0 kcal/mL; NCT05609006). Patients were randomly assigned to two 8-week treatment sequences of four-weeks periods: edONS + heONS (sequence A) or heONS + edONS (sequence B). Patients daily reported the amount of product left over gastrointestinal tolerance and satisfaction with ONS. A non-inferiority analysis was performed to compare the compliance rate (percentage of consumed energy over the prescribed) for each period and sequence. Results: Fifty-three patients were assigned to sequence A and 50 to sequence B (55.7 ± 13.9 years, 37.0% female, 67.1% oncology patients). In sequence A, the compliance rates were 88.6% ± 14.3% vs. 84.1 ± 21.8% (p = 0.183), while in sequence B, they were 78.9% ± 23.8% vs. 84.4% ± 21.4% (p < 0.01). In both sequences, the lower range of the confidence interval for compliance with edONS was greater than the non-inferiority threshold (for sequence A ΔCompA was 4.5% [95% CI, -2.0% to 10.0%], and for sequence, B ΔCompB was 5.6% [95% CI, -3.0% to 14.0%]). The total discarded cost for each ONS was higher for heONS than edONS, being the difference statistically significant in sequence B. BMI increased slightly and not significantly in both sequences, and the percentage of patients with severe malnutrition was reduced. The frequency of gastrointestinal symptoms was low for both sequences, and satisfaction with ONS was slightly higher for edONS. Conclusion: Our findings highlight that edONS was non-inferior to heONS in terms of consumed energy over the prescribed, with a lower amount of edONS discarded, which suggests a higher efficiency of edONS.

[Home and Ambulatory Artificial Nutrition (NADYA) Group report: home parenteral nutrition in Spain, 2019]. / Nutrición parenteral domiciliaria en España, 2019: informe del Grupo de Nutrición Artificial Domiciliaria y Ambulatoria NADYA.

INTRODUCTION: Aim: to communicate the home parenteral nutrition (HPN) data obtained from the HPN registry of the NADYA-SENPE group (www.nadya-senpe.com) for the year 2019. Material and methods: a descriptive analysis of the data collected from adult and pediatric patients with HPN in the NADYA-SENPE group registry from January 1 to December 31, 2019. Results: a total of 283 patients (51.9 % women), 31 children, and 252 adults from 47 Spanish hospitals were registered, which represents a prevalence rate of 6.01 patients per million inhabitants for year 2019. The most frequent diagnosis in adults was "palliative oncological" and "others" (21.0 %). In children, it was Hirschsprung's disease together with necrotizing enterocolitis, alterations in intestinal motility, and chronic intestinal pseudo-obstruction, with 4 cases each (12.9 %). The first reason for the indication was short-bowel syndrome in both children (51.6 %) and adults (37.3 %). The most used type of catheter was tunnelled both in children (75.9 %) and in adults (40.8 %). Sixty-eight episodes ended, all in adults, and the most frequent cause was death (54.4 %); 38.2 % were switched to oral. Conclusions: the number of collaborating centers and professionals in the NADYA registry is increasing. The main indications and reasons for HPN termination remain stable.

INTRODUCCIÓN: Objetivo: comunicar los datos de nutrición parenteral domiciliaria (NPD) obtenidos del registro del grupo NADYA-SENPE (www.nadya-senpe.com) del año 2019. Material y métodos: análisis descriptivo de los datos recogidos de pacientes adultos y pediátricos con NPD en el registro NADYA-SENPE desde el 1 de enero al 31 de diciembre de 2019. Resultados: se registraron 283 pacientes (51,9 %, mujeres), 31 niños y 252 adultos procedentes de 47 hospitales españoles, lo que representa una tasa de prevalencia de 6,01 pacientes/millón de habitantes/año 2019. El diagnóstico más frecuente en los adultos fue "oncológico paliativo" y "otros" (21,0 %). En los niños fue la enfermedad de Hirschsprung junto a la enterocolitis necrotizante, las alteraciones de la motilidad intestinal y la pseudoobstrucción intestinal crónica, con 4 casos cada uno (12,9 %). El primer motivo de indicación fue el síndrome del intestino corto tanto en los niños (51,6 %) como en los adultos (37,3 %). El tipo de catéter más utilizado fue el tunelizado tanto en los niños (75,9 %) como en los adultos (40,8 %). Finalizaron 68 episodios, todos en adultos: la causa más frecuente fue el fallecimiento (54,4 %). Pasaron a la vía oral el 38,2 %. Conclusiones: el número de centros y profesionales colaboradores con el registro NADYA va incrementándose. Se mantienen estables las principales indicaciones y los motivos de finalización de la NPD.

[Home and Ambulatory Artificial Nutrition (NADYA) Group Report. Home parenteral nutrition in Spain, 2018]. / Nutrición parenteral domiciliaria en España 2018. Informe del Grupo de Nutrición Artificial Domiciliaria y Ambulatoria NADYA.

INTRODUCTION: Aim: to communicate home parenteral nutrition (HPN) data obtained from the HPN registry of the NADYA-SENPE group (www.nadya-senpe.com) for the year 2018 Material and methods: descriptive analysis of the data collected from adult and pediatric patients with HPN in the NADYA-SENPE group registry from January 1st, 2018 to December 31st, 2018. Results: there were 278 patients from 45 Spanish hospitals (54.7% women), 23 children and 255 adults, which represent a prevalence rate of 5.95 patients/million inhabitants/year 2018. The most frequent diagnosis in adults was "palliative cancer" (22.0%), followed by "others". In children it was Hirschsprung's disease together with necrotizing enterocolitis, with four cases (17.4%). The first indication was short bowel syndrome in both children (60.9%) and adults (35.7%). The most frequently used type of catheter was tunneled in both children (81.0%) and adults (41.1%). Ending 75 episodes, the most frequent cause was death (52.0%) and change to oral feeding (33.3%). Conclusions: the number of centers and collaborating professionals in the registry of patients receiving HPN remains stable, as well as the main indications and reasons for termination of HPN.

INTRODUCCIÓN: Objetivo: comunicar los datos de nutrición parenteral domiciliaria (NPD) obtenidos del registro del grupo NADYA-SENPE (www.nadya-senpe.com) del año 2018. Material y métodos: análisis descriptivo de los datos recogidos de pacientes adultos y pediátricos con NPD en el registro NADYA-SENPE del 1 de enero al 31 de diciembre de 2018. Resultados: se registraron 278 pacientes (54,7% mujeres), 23 niños y 255 adultos, procedentes de 45 hospitales españoles, lo que representa una tasa de prevalencia de 5,95 pacientes/millón de habitantes/año 2018. El diagnóstico más frecuente en adultos fue "oncológico paliativo" (22,0%), seguido de "otros". En niños fue la enfermedad de Hirschsprung junto con la enterocolitis necrotizante, con cuatro casos (17,4%). El primer motivo de indicación fue síndrome de intestino corto tanto en niños (60,9%) como en adultos (35,7%). El tipo de catéter más utilizado fue el tunelizado tanto en niños (81,0%) como en adultos (41,1%). Finalizaron 75 episodios, la causa más frecuente fue el fallecimiento (52,0%) y el paso a vía oral (33,3%). Conclusiones: el número de centros y profesionales colaboradores en el registro de pacientes que reciben NPD se mantiene estable, así como las principales indicaciones y los motivos de finalización de la NPD.

Adherence to Mediterranean diet: A comparison of patients with head and neck cancer and healthy population. / Adherencia a la dieta mediterránea: comparación entre pacientes con cáncer de cabeza y cuello y población sana.

BACKGROUND AND OBJECTIVE: The traditional Mediterranean diet (MD) is associated to a lower risk of suffering multiple tumors. However, few studies have analyzed the relationship between MD and the risk of developing head and neck cancer (HNC). A case-control study comparing adherence to MD was conducted in patients diagnosed with HNC and healthy population. PATIENTS AND METHODS: The level of adherence to MD was assessed using the 14-item MEDAS (Mediterranean Diet Adherence Screener) questionnaire, used in the PREDIMED study, in patients diagnosed with HNC at 12de Octubre Hospital in Madrid (cases) and in healthy subjects enrolled in a nearby primary health care center (controls). Adherence was stratified based on the score as low (≤7points), medium (8-9points), and high (≥10points). The odds ratio (OR) for developing HNC was estimated based on different factors. RESULTS: A sample of 168 subjects (100 controls and 68 cases) was analyzed. Smoking (OR, 2.98 [95%CI: 1.44-6.12]; P=.003) and alcohol consumption (OR, 2.72 [95%CI: 1.39-5.33], P=.003) were strongly associated to HNC. However, medium-high adherence to MD was associated to a lower risk of developing HNC (OR, 0.48 [95%CI: 0.20-1.07], P=.052). CONCLUSIONS: Consistent medium-high adherence to MD contributes to decrease the risk of developing HNC.

[Home and Ambulatory Artificial Nutrition (NADYA) Report. Home Parenteral Nutrition in Spain, 2017]. / Nutrición parenteral domiciliaria en España 2017. Informe del Grupo de Nutrición Artificial Domiciliaria y Ambulatoria NADYA.

AIM: to communicate HPN data obtained from the HPN registry of the NADYA-SENPE group (www.nadya-senpe.com) for the year 2017. MATERIAL AND METHODS: descriptive analysis of the data collected from adult and pediatric patients with HPN in the NADYA-SENPE group registry from January 1st, 2017 to December 31st, 2017. RESULTS: there were 308 patients from 45 Spanish hospitals (54.5% women), 38 children and 270 adults, with 3,012 episodes, which represent a prevalence rate of 6.61 patients/million inhabitants/year 2017. The most frequent diagnosis in adults was "palliative cancer" (25.6%), followed by "others". In children, it was Hirschsprung's disease with six cases (15.8%). The first indication was short bowel syndrome in both children (55.3%) and adults (33.7%). The most frequently used type of catheter was tunneled in both children (73.4%) and adults (38.2%). Ending 81 episodes, the most frequent cause was death (62.9%) and transition to oral feeding (34.7%). CONCLUSIONS: the progressive increase of collaborating centers and professionals in the registry of patients receiving NPD is maintained. The main indications of HPN and the motive for ending have remained stable.

OBJETIVO: comunicar los datos de nutrición parenteral domiciliaria (NPD) obtenidos del registro del grupo NADYA-SENPE (www.nadya-senpe. com) del año 2017. MATERIAL Y MÉTODOS: análisis descriptivo de los datos recogidos de pacientes adultos y pediátricos con NPD en el registro NADYA-SENPE desde el 1 de enero al 31 de diciembre de 2017. RESULTADOS: se registraron 308 pacientes (54,5% mujeres), 38 niños y 270 adultos, procedentes de 45 hospitales españoles, en total 312 episodios, lo que representa una tasa de prevalencia de 6,61 pacientes/millón de habitantes/año 2017. El diagnóstico más frecuente en adultos fue "oncológico paliativo" (25,6%), seguido de "otros". En niños fue la enfermedad de Hirschsprung, con seis casos (15,8%). El primer motivo de indicación fue síndrome de intestino corto tanto en niños (55,3%) como en adultos (33,7%). El tipo de catéter más utilizado fue el tunelizado tanto en niños (74,3%) como en adultos (38,2%). Finalizaron 81 episodios; la causa más frecuente fue el fallecimiento (62,9%) y que pasaron a vía oral (34,7%). CONCLUSIONES: se mantiene el incremento progresivo de centros y profesionales colaboradores en el registro de pacientes que reciben NPD. Las principales indicaciones de NPD y de motivo de finalización se mantienen estables.