Effect of inulin and fructo-oligosaccharide on the prevention of acute radiation enteritis in patients with gynecological cancer and impact on quality-of-life: a randomized, double-blind, placebo-controlled trial.

BACKGROUND/OBJECTIVES: The pathogenesis of enteritis after abdominal radiotherapy (RT) is unknown, although changes in fecal microbiota may be involved. Prebiotics stimulate the proliferation of Lactobacillus spp and Bifidobacterium spp, and this may have positive effects on the intestinal mucosa during abdominal RT. SUBJECTS/METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with gynecological cancer who received abdominal RT after surgery. Patients were randomized to receive prebiotics or placebo. The prebiotic group received a mixture of fiber (50 inulin and 50% fructo-oligosaccharide), and the placebo group received 6 g of maltodextrin twice daily from 1 week before to 3 weeks after RT. The number of bowel movements and stool consistency was recorded daily. Diarrhea was evaluated according to the Common Toxicity Criteria of the National Cancer Institute. Stool consistency was assessed using the 7-point Bristol scale. Patients' quality-of-life was evaluated at baseline and at completion of RT using the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer quality-of-life Questionnaire C30) test. RESULTS: Thirty-eight women with a mean age of 60.3±11.8 years participated in the study. Both groups (prebiotic (n=20) and placebo (n=18)) were comparable in their baseline characteristics. The number of bowel movements per month increased in both groups during RT. The number of bowel movements per day increased in both groups. The number of days with watery stool (Bristol score 7) was lower in the prebiotic group (3.3±4.4 to 2.2±1.6) than in the placebo group (P=0.08). With respect to quality-of-life, the symptoms with the highest score in the placebo group were insomnia at baseline and diarrhea toward the end of the treatment. In the prebiotic group, insomnia was the symptom with the highest score at both assessments, although the differences were not statistically significant. CONCLUSIONS: Prebiotics can improve the consistency of stools in gynecologic cancer patients on RT. This finding could have important implications in the quality-of-life of these patients during treatment.

Effect of a mixture of inulin and fructo-oligosaccharide on Lactobacillus and Bifidobacterium intestinal microbiota of patients receiving radiotherapy: a randomised, double-blind, placebo-controlled trial.

BACKGROUND & AIMS: The pathogenesis of enteritis after abdominal radiotherapy is unknown, although changes in faecal microbiota may be involved. In several studies, Lactobacillus and Bifidobacterium have proven beneficial for the host. Prebiotics stimulate the proliferation of Lactobacillus and Bifidobacterium, and this may have positive effects on the intestinal mucosa during abdominal radiotherapy. METHODS: We performed a randomised double-blind, placebo-controlled trial including 31 patients with gynaecological cancer who received radiotherapy (29 sessions, 52.2 Gy) after surgery. Patients were randomised to two groups: prebiotic and placebo. The first group received a mixture of fibre (50% inulin and 50% fructo-oligosaccharide) and the second received 6 g of maltodextrin twice daily from one week before to three weeks after radiotherapy. Lactobacillus and Bifidobacterium counts were determined in faeces samples (day -7 before radiotherapy, day 15 of radiotherapy, at the end of treatment, and three weeks after radiotherapy) by culture in selective media and fluorescent in situ hybridization (FISH) using genus-specific probes. Bacterial counts by FISH were significantly higher than by culture method. RESULTS: There were no differences in baseline microbiota between groups. At the end of radiotherapy, we observed a statistically significant decrease in Lactobacillus and Bifidobacterium counts in both groups. By cultural analysis, we observed higher numbers of Lactobacillus and Bifidobacterium three weeks after radiotherapy in the prebiotic group (5.6 vs. 6.3, p = 0.04 and 5.5 vs. 6 log cfu/g, p = 0.03). CONCLUSIONS: Abdominal radiotherapy negatively affects Lactobacillus and Bifidobacterium counts. The prebiotic mixture of inulin and fructoligosaccharide can improve the recovery of both genera after radiotherapy. Registered under ClinicalTrials.gov Identifier no. NCT01549782.

Long-term prevalence of oropharyngeal dysphagia in head and neck cancer patients: Impact on quality of life.

BACKGROUND & AIMS: To determine the prevalence of dysphagia in head and neck cancer patients treated with surgery and radiotherapy or chemoradiotherapy. To study the impact of dysphagia on food habits, nutritional status, and quality of life. METHODS: Retrospective cross-sectional study of 87 head and neck cancer patients treated with surgery and radiotherapy or chemoradiotherapy from January 2000 through May 2005. Time since surgery was 28.5+/-17.8 months. A clinical test was used to detect dysphagia. A nutritional assessment was performed in all patients. A questionnaire was used to evaluate quality of life. RESULTS: Oropharyngeal dysphagia was present in 50.6% of patients, mostly to solid foods (72.4%). Patients with total glossectomy and chemoradiotherapy had the highest rate of dysphagia. Nutritional support was necessary in 57.1% of patients. Malnutrition was present in 20.3% of patients, mainly marasmus (81%). Fifty-one percent of patients reported a decrease in their quality of life due to dysphagia. CONCLUSIONS: We found a high prevalence of dysphagia in head and neck cancer patients treated with surgery and coadjuvant treatment. This problem negatively affects their quality of life. It is important that nutritional surveillance be provided to detect it and to prevent malnutrition.

[The year 2003 National Registry of Home-based Parenteral Nutrition]. / Registro Nacional de la Nutrición Parenteral Domiciliaria del año 2003.

OBJECTIVE: To report the results of the Home-based Parenteral Nutrition (HBPN) registry of the NADYA-SENPE working group, for the year 2003. MATERIAL AND METHODS: Gathering of registry data introduced by all units responsible of HBPN patient care. This an on-line registry available for authorized users of the working group web page (www.nadya-senpe.com). Epidemiological data, diagnosis, access route, complications, hospital admissions, disability degree, and course at December 31st, 2003 RESULTS: Data from 86 patients (62% female and 38% male) from 17 hospitals were gathered. Mean age of adult patients was 50.7 +/- 15.0 years, whereas for patients younger than 14 years was 2.4 +/- 1.5 years (n = 5 patients). Diseases that prone HBPN were neoplasm (21%), followed by mesenteric ischemia (20%), radiation enteritis (16.3%), motility impairments (10.5%), and Crohn's disease (4.6%). Tunneled catheters were used in 66.3% of the cases versus 29.1% of subcutaneous reservoirs. Mean treatment duration has been 8.5 +/- 4.6 months; 67.4% of patients had been on HBPN for a period of time longer than 6 months. Patient follow-up was mostly done from the reference area hospital (88.4%). In no case patient follow-up was done by the primary care team or by specialists other than those prescribing nutritional support. Nutritional support-related complications were seen in 98 occasions. The most frequent complications were infectious ones. They represented 1.60 hospital admissions per patient. The mean number of visits was 7.9 per patient (6.4 for scheduled visits and 1.5 for emergency visits). By the end of the year, we observed that 73.3% of the patients were still on the program, whereas in 23.3% HBPN had been withdrawn. The main reasons for withdrawal were decease (11 patients), and advancing to oral diet (9 patients). As for the disability degree, 13% were confined to a wheelchair or bed, and only 28% had no disability degree or only mild social disability. CONCLUSIONS: We observed a mild increase in HBPN prevalence rate in Spain (2.15 patients pmp). The main indication was cancer followed by short-bowel syndrome secondary to vascular pathology. Nutritional support-related complications were common, especially those of an infectious origin.

[The year 2002 national register on home-based parenteral nutrition]. / Registro nacional de la nutrición parenteral domiciliaria del año 2002.

AIM: To report on the results of the Registry on Home-based Parenteral Nutrition (HPN) of the NADYA-SENPE working group, corresponding to the year 2002. MATERIALS AND METHOD: Compilation of the registry data loaded by the Units in charge of HPN patients care. It consists of an on-line registry available to the registered users of the group's web page (www.nadya-senpe.com). Epidemiological, diagnostic, access route, complications, hospital admissions, degree of disability, and course until December 31st of 2002. RESULTS: Data from 74 patients were gathered (56.8% women and 43.2% men), from 18 hospital centers. Mean age of adult patients was 49.4 +/- 15.5 years and 2.3-1.1 years for patients younger than 14 years (n=3 patients). Diseases that prompted the use of HPN were mesenteric ischemia (29.7%), followed by neoplasms (16.2%), radiation enteritis (12.2%), motility impairments (8.1%), and Crohn's disease (5.4%). Tunneled catheters were used in 52.7% of cases, as compared to 36.5% of subcutaneous reservoirs. Mean treatment duration was 8.7 +/- 4.4 months; 68.9% of patients remained on HPN for a duration longer than 6 months, and in 41.9% longer than one year. Patients' follow-up was mainly done from the reference hospital (87.8%), and the remaining patients (12.5%) by the home care team. In no case patients were followed by the primary care team or other specialists than the ones that prescribed nutritional support. In 94 cases there were complications related to nutritional therapy. The more frequent complications presented were infectious. These complications represented 1.84 admissions per patient. The mean number of visits was 12.9 per patient (10.2 routinary visits and 2.7 emergency visits). At the end of the year, we observed that 74.3% patients stayed in the program, whereas in the remaining 23.6% HPN had been discontinued. The main causes for discontinuation were death (52.9%), and switch to oral diet (23.5%) or enteral nutrition (11.8%). With regards to disability degree, 16.1% were confined to a wheelchair or bed, and 17.6% had no disability at all or only a mild social disability. CONCLUSIONS: We observed a sustained HPN prevalence rate in Spain (1.8 patient pmp). The main cause for its use was short bowel syndrome secondary to vascular disease, followed by cancer. Complications associated to nutritional therapy were common, especially of infectious origin.

Nutritional support and quality of life in stable chronic obstructive pulmonary disease (COPD) patients.

RATIONALE: Nutritional depletion is a common problem in chronic obstructive pulmonary disease (COPD) patients. It is caused, to a large extent, by an imbalance between low-energy intake and high-energy requirements. This problem adversely affects morbidity and mortality. However, the use of nutritional supplements to reach their energy necessities requires optimisation between positive and adverse effects on outcome before being used systematically as part of their comprehensive care. PURPOSE: The aim of our study was to investigate the effects of oral nutritional repletion on quality of life in stable COPD patients. METHODS: Prospective, randomised and multi-centre study. Stable COPD patients with a body mass index 22, a fat-free mass index 16, and/or a recent involuntary weight loss (5% during last month, or 10% during the last 3 months) were studied. Exclusion criteria were to present signs of an airway infection, to have a cardiovascular, neurological, or endocrine disease, to be treated with oral steroids, immunosuppressors or oxygen therapy at home, and to receive nutritional supplements. During 12 weeks, patients were encouraged to ingest a total daily defined energy intake. Randomly, in patients from group A the total daily energy load was Resting Energy Expenditure (REE)x1.7, and those from group B, REE x1.3. Total daily energy intake was achieved with regular food plus, if necessary, oral nutritional supplement rich in proteins (with 50% of whey protein), with predominance of carbohydrates over fat, and enriched in antioxidants. Primary end-point variable was quality of life. Secondary end-point outcomes included body weight, body composition, lung function, handgrip strength, and compliance with the energy intake previously planned. Data were treated with a SAS System. Student's test, Wilcoxon's rank sum test, and Mann-Whitney's test were used. RESULTS: At baseline both groups of patients were comparable. All patients needed oral nutritional supplements to achieve total daily defined energy intake. After 12 weeks of follow-up, patients in both groups significantly increased energy intake. Patients in group A increased body weight (P=0.001), triceps skin fold thickness (P=0.009) and body fat mass (P=0.02), and decreased body fat-free mass index (P=0.02). In this group a marked increase in airflow limitation was observed. A tendency to increase body weight and handgrip strength, and to decrease airflow limitation was observed in patients from group B. Furthermore, patients in the later group showed a significant improvement in the feeling of control over the disease (P=0.007) and a tendency to better the other criteria in a quality of life scale. CONCLUSIONS: According to our results, total daily energy intake of REE x 1.3 is preferable to REE x 1.7 in mild stable COPD patients. The administration of oral nutritional supplements, rich in proteins (with 50% of whey protein), with predominance of carbohydrates over fat, and enriched in antioxidants, to achieve total daily defined energy intake in patients in group B was followed by a significant improvement of one criteria (mastery) among many others in a quality of life scale.

[Osteoporosis and inflammatory bowel disease]. / Osteoporosis y enfermedad inflamatoria intestinal.

Inflammatory bowel disease is a chronic disease with an unknown ethiology although multiple factors intervene such as individual, genetic and immunologic susceptibility, as well as different environmental factors. Like other multisystemic diseases, its clinical manifestations are diverse and it may affect other organs besides the gastrointestinal tract. In the last few years there is a growing interest for one of these extraintestinal manifestations, osteoporosis and osteopenia that may affect up to 42% of patients and can condition an important increase in morbility. Inactivity, prolonged corticosteroid treatment, nutritional deficiencies and the disease per se have an important role in the development of this complication. This article reviews clinical and ethiological aspects of inflammatory bowel disease associated osteoporosis and offers a strategy for diagnosis and treatment.

[National Registry of Home Parenteral Nutrition of the year 2001]. / Registro Nacional de la Nutrición Parenteral Domiciliaria (NPD) del año 2001.

AIM: We analyse the registered data of home parenteral nutrition (HPN) in our country during the year 2001. METHOD: The data were collected through a previously designed questionnaire. Apart from epidemiological information, the form includes the disease to prescribe this treatment, the specific nutritional treatment used and its duration, access path, complications and readmission rate in hospital, follow-up of the treatment, and progress. All data were processed and analysed by the co-ordinating team. RESULTS: Seventeen hospitals participated, and 66 patients were enrolled. Middle age was 5.5 +/- 4.9 years for patients < 14 years old, and 49.2 +/- 15.8 years for those > or = 14 years old. The more prevalent diagnosis were: ischemic bowel (28.9%), neoplasm (22.7%), radiation enteritis (12.1%), motility disorders (4.5%) and Crohn's disease (4.5%). The mean time on HPN was 8.4 +/- 4.5 months. Tunnelled catheter was the preferential route (62.1%), followed by the implantated one (33.3%). The intermittent method (nocturnal) was preferential (81.8%). Patients receive the formula, mainly from hospital pharmacy (75.7%). The complications related to nutrition (1.3/patient) included the infections (0.46 sepsis/patient, and 0.19 catheter contamination/patients), mechanic (0.15/patient), metabolic (0.1/patient) and electrolytic disorders (0.07/patient). The readmission rate, for nutritional problems, was 1.34/patient. At the end of the year, 74.2% of the patients remained in the HPN program, and 25.8% abandoned the treatment (due to death: 52.9%, and to progress to oral feeding (25.3%). CONCLUSIONS: This review illustrates that the registration of HPN patients in our country is standing (1.65 patients/10(6) habitants), that vascular pathology is the more frequent diagnoses in HPN patients, and the rate of readmission and complications and the behaviour is similar to other series making this as a safe treatment in our place.

[Home Enteral Nutrition: National Registry 2001]. / Nutrición Enteral Domiciliaria (NED): registro nacional 2001.

GOAL: The NADYA-SENPE Working Group analyzed the registered data of patients on Home Enteral Nutrition (HEN) in our country, during year 2001. MATERIAL AND METHODS: The data were collected through a closed questionnaire included on our web site (www.nadya-senpe.com). Apart from epidemiological information, the form includes the indication to prescribe this treatment, the specific nutritional treatment used and its duration, access path, complications and readmission rate in hospital, follow-up of the treatment, patient's quality of life and progress. All data were processed and analyzed by the coordinating team. RESULTS: Twenty two hospitals participated and 3,458 patients, aged 5.6 +/- 4.0 y for those younger than 14 y, and 67.1 +/- 19.5 y for those older than 14 y, were enrolled. Of these patients, 43.4% were diagnosed with neurological diseases and 33.5% with cancer. The mean time on HEN was 6.5 +/- 4.5 months. Oral nutrition was the preferential route (54.5%), followed by nasoenteral tube (32.3%), and in 13.3% ostomy tubes were placed. Polymeric was the formula composition mainly used (85.9%). Patients were followed (71.1%) by the hospital reference Nutritional Support Unit. The complications related to nutrition included mainly the gastrointestinal (0.16 complications/patient), and the mechanical one (0.15 complications/patient). At the end for the year, 48.3% of the patients were in the HEN program, and in 33.3% HEN was finish due to different reasons. In 22.9% of the patients no, o light, discapacity degree was found. CONCLUSIONS: Neurological diseases and cancer were the more frequent diagnoses in HEN patients. Oral access was the higher feeding route due, probably, to the high prevalence of cancer patients. In spite of the elevated prevalence of neurological diseases, a few number of patients, as previous years, were feed with ostomy tube. Due to the few complications observed, HEN is a safe treatment in our country.

Copper deficiency with pancytopenia due to enteral nutrition through jejunostomy.

Copper deficiency is a rare complication of enteral nutrition. Haematologic abnormalities such as neutropenia and anaemia, but not pancytopenia, have been described associated to copper deficiency. We report the case of a patient requiring long term enteral nutrition through jejunostomy who developed copper deficiency and pancytopenia. In 1991, a 47-year-old woman was admitted with severe gastroesophageal mucositis after an attempted suicide with caustic intake. Enteral nutrition with a commercial, polymeric, fiber-containing formula was started. Twenty-eight months later, the patient developed anemia and neutropenia that did not respond to combined iron and parenteral vitamin B(12) supplementation. In 1996 the patient showed pancytopenia and low serum levels of copper and ceruloplasmin. Pancytopenia improved after copper supplementation. Possible mechanism causing copper deficiency and pancytopenia are discussed. We conclude that assessment of copper status is advisable in patients receiving long-term enteral nutrition by jejunostomy.

Results of external pituitary irradiation after unsuccessful transsphenoidal surgery in Cushing's disease.

Fourteen adult patients (10 females and 4 males; age range 20-60 years) with persistent Cushing's disease after transsphenoidal microsurgery were treated with pituitary irradiation. Supervoltage multiportal administration was employed at a total dose of 50 Gy (+/- 0.65 SD). The interval between microsurgery and pituitary irradiation was less than 6 months in 6 patients and more than 6 months in 8. The pituitary-adrenal axis was evaluated postsurgically, before irradiation and every 6 months thereafter. The remaining anterior pituitary function was simultaneously tested. Remission rates at 12 months and 24 months after radiotherapy were 61 and 70%, respectively. Two patients developed TSH deficiency and another gonadotropin deficiency during the follow-up after radiation. We conclude that pituitary irradiation is the treatment of choice for persistent Cushing's disease after unsuccessful surgery because of its high efficiency and low incidence of adverse reactions when compared with other forms of treatment.