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1.
Nutritional support dependence after curative chemoradiotherapy in head and neck cancer: supplementary analysis of a phase II trial (JCOG0706S1).
Imamura, Y, Kiyota, N, Ogawa, G, Akimoto, T, Fujii, M, Hanai, N, Iwae, S, Monden, N, Matsuura, K, Onozawa, Y, et al
Japanese journal of clinical oncology. 2019;(11):1009-1015
Abstract
OBJECTIVES To explore the risk factors of laryngo-esophageal dysfunction-free survival and nutritional support dependence over 12 months in patients with unresectable locally advanced head and neck carcinomas who received chemoradiotherapy in a phase II trial of JCOG0706 (UMIN000001272). METHODS Forty-five patients received radiation therapy for a total of 70 Gy/35fr concurrently with S-1 and cisplatin. Risk factors of laryngo-esophageal dysfunction-free survival and nutritional support dependence over 12 months were analyzed using Cox regression models and logistic regression models, respectively, with consideration to patient laboratory data just before chemoradiotherapy. Radiation fields were reviewed to analyze the relationship between the extent of the irradiated field and functional outcome. RESULTS With a median follow-up period of 3.5 years, 3-year laryngo-esophageal dysfunction-free survival was 48.9%. For laryngo-esophageal dysfunction-free survival, hazards ratio of 2.35 in patients with nutritional support at registration (vs. without nutritional support; 95% confidence interval 0.96-5.76). For nutritional support dependence over 12 months, odds ratio was 6.77 in patients with hemoglobin less than the median of 13.4 g/dl (vs. higher than or equal to the median; 95% confidence interval 1.24-36.85) and was 6.00 in patients with albumin less than the median of 3.9 g/dl (vs. higher than or equal to the median; 95% confidence interval 1.11-32.54). Primary sites in disease-free patients with nutritional support dependence over 12 months were the oropharynx (N = 2) or hypopharynx (N = 1), and all pharyngeal constrictor muscles were included in irradiated fields with a curative dose. CONCLUSIONS This supplementary analysis showed that pretreatment severe dysphagia requiring nutritional support, anemia and hypoalbuminemia might have a negative prognostic impact on long-term functional outcomes after curative chemoradiotherapy in head and neck cancer.
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2.
Optimized calorie and high protein intake versus recommended caloric-protein intake in critically ill patients: a prospective, randomized, controlled phase II clinical trial.
Azevedo, JRA, Lima, HCM, Montenegro, WS, Souza, SCC, Nogueira, IROM, Silva, MM, Muniz, NA
Revista Brasileira de terapia intensiva. 2019;(2):171-179
Abstract
OBJECTIVE To evaluate differences in outcomes for an optimized calorie and high protein nutrition therapy versus standard nutrition care in critically ill adult patients. METHODS We randomized patients expected to stay in the intensive care unit for at least 3 days. In the optimized calorie and high protein nutrition group, caloric intake was determined by indirect calorimetry, and protein intake was established at 2.0 to 2.2g/kg/day. The control group received 25kcal/kg/day of calories and 1.4 to 1.5g/kg/day protein. The primary outcome was the physical component summary score obtained at 3 and 6 months. Secondary outcomes included handgrip strength at intensive care unit discharge, duration of mechanical ventilation and hospital mortality. RESULTS In total, 120 patients were included in the analysis. There was no significant difference between the two groups in calories received. However, the amount of protein received by the optimized calorie and high protein nutrition group was significantly higher compared with the control group. The physical component summary score at 3 and 6 months did not differ between the two groups nor did secondary outcomes. However, after adjusting for covariates, a negative delta protein (protein received minus predetermined protein requirement) was associated with a lower physical component summary score at 3 and 6 months postrandomization. CONCLUSION In this study optimized calorie and high protein strategy did not appear to improve physical quality of life compared with standard nutrition care. However, after adjusting for covariates, a negative delta protein was associated with a lower physical component summary score at 3 and 6 months postrandomization. This association exists independently of the method of calculation of protein target.
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3.
The Efficacy of an Oral Elemental Diet in Patients Undergoing Hematopoietic Stem Cell Transplantation.
Morishita, T, Tsushita, N, Imai, K, Sakai, T, Miyao, K, Sakemura, R, Kato, T, Niimi, K, Ono, Y, Sawa, M
Internal medicine (Tokyo, Japan). 2016;(24):3561-3569
Abstract
Objective Conditioning regimens for hematopoietic stem cell transplantation (HSCT) are well known to cause severe gastrointestinal toxicities that often disturb the oral intake of the patients followed by poor nutrition and life-threatening infection. An oral elemental diet (ED) is an easily consumed and assimilated form of liquid nutrients mainly composed of amino acids. It alleviates the digestive loading from the intestine and is mainly used for enteral nutritional support in patients with Crohn's disease. We herein report, for the first time, the efficacy of ED for patients undergoing HSCT. Methods We evaluated the efficacy of ED in a prospective cohort study. The primary endpoint for this study was the hospitalization period. The secondary endpoint was the occurrence of oral mucositis, nausea, diarrhea and fever. Patients A total of 73 patients were consecutively enrolled between March 2011 and March 2013. Twenty-three patients underwent autologous HSCT and 50 patients underwent allogeneic HSCT. The first 21 patients did not receive ED (non-ED group; NEG) while in the successive 52 patients (ED group; EG), oral ED was started before conditioning and was continued until 28 days after transplantation. Results The patient characteristics were similar between the two groups. The mean duration of ED administration for EG was 28.7 days (range, 3-37 days), and the mean total-dose of ED administration was 1904 g (range, 240-2,960 g). The median hospitalization period was significantly shorter in EG compared to NEG, (34 days vs. 50 days; p=0.007). Grade 3-4 oral mucositis occurred less in EG than NEG (25% vs. 48%; p=0.06). Conclusion Oral ED may promote an early mucosal recovery and thereby shorten the duration of hospitalization.
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4.
Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients.
Machon, C, Thezenas, S, Dupuy, AM, Assenat, E, Michel, F, Mas, E, Senesse, P, Cristol, JP
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2012;(12):3129-35
Abstract
PURPOSE Inflammatory, angiogenic and oxidative stress markers have been explored in head and neck squamous cell carcinoma (HNSCC) patients before and during radiochemotherapy. Furthermore, the effects of an oral supplementation containing amino acids, ω-3 fatty acids, ribonucleic acids, vitamins, and antioxidants on biological markers and acute toxicities were investigated. METHODS Thirty-one patients with non-metastatic stage III or IV HNSCC treated with concomitant radiochemotherapy were recruited. A nutritional support (Oral Impact) was given during 5 days before each cycle of chemotherapy. Biological samples were collected at baseline, after 5 days of oral supplementation and before the last cycle of chemotherapy. Acute phase proteins levels, proteomic cytokines determination and urinary isoprostanes levels were used as inflammatory and oxidative stress biomarkers. Toxicities were followed up during radiochemotherapy. RESULTS At baseline, median levels of inflammatory (CRP 9.8 mg/l [0.8-130.1], IL-6 4.2 pg/ml [0.7-126.5]), pro-angiogenic (VEGF 229.5 pg/ml [13.1-595.9]) and pro-oxidative stress (urinary isoprostanes 118 pmol/mmol creatinine [51-299]) markers were increased. Decrease in CRP (p = 0.002) and α-1 acid glycoprotein (p = 0.020) levels were observed after 5 days of oral supplementation. During radiochemotherapy, no significant variation of inflammatory markers was reported, and a low incidence of severe acute mucositis was noted. CONCLUSIONS Stage III or IV HNSCC patients are characterised by a pro-inflammatory, pro-angiogenic and pro-oxidative status. Nutritional support could improve this inflammatory state and could prevent severe acute mucositis.
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5.
[Tumor markers p53, sFAS, FASL, CEA and CA 19-9 in evaluating the effectiveness of surgical and pharmaco nutritional treatment of patients with gastric cancer].
Bluvshteĭn, GA, Lysenko, VG, Zakharova, NB, Kitaev, IV
Eksperimental'naia i klinicheskaia gastroenterologiia = Experimental & clinical gastroenterology. 2012;(2):41-9
Abstract
UNLABELLED The objective of this study is to develop a marker panel of abnormalities of immune regulatory systems and cell genome in patients with gastric cancer for assessment of efficacy of surgical treatment in combination with pharmaco-nutritional therapy in early postoperative period. MATERIALS AND METHODS Expression of p53, sFAS, FASL, CEA, and CA 19-9, nutritial status, as well as incidence of purulent-septic complications in early postoperative period were determined in 40 patients with gastric cancer (21 patients--the test group and 19 patients--the comparative group) prior to a curative surgical intervention, postoperative days 1 and 7, while the pharmaco-nutritional therapy (the test group) or partial parenteral nutrition (the comparative group) has been performed. RESULTS The pharmaco-nutritional therapy significantly decreases in activity of tumor suppressing genome, lymphocyte apoptosis, expression of oncology-associated markers, incidence of purulent-septic complications, as well as exacerbation risk for hypotrophy in patients with gastric cancer in early postoperative period. CONCLUSION To assess the efficacy of the surgical intervention performed in patients with gastric cancer, an expression of mutant p53 and markers of lymphocyte apoptosis (sFAS/FASL) is reasonable to be evaluated together with determination of oncomarkers (CEA and CA 19-9).
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6.
[Nutrition support of patients with celiac disease and deficiency of carbohydrases of the small intestinal mucosa].
Kostiuchenko, LN, Belostotskiĭ, NI, Akhmadullina, OV, Ruchkina, IN, Vorob'eva, NN, Sabel'nikova, EA, Parfenov, AI
Eksperimental'naia i klinicheskaia gastroenterologiia = Experimental & clinical gastroenterology. 2012;(2):8-14
Abstract
The treatment policy of nutritive support for patients with different types of celiac disease is still actual issue. The difficulty of treatment policy implementation associated with villus atrophy, that brings on not only small intestine malabsorption function, but secretory process disorder (particularly, some of intestinal ferments production, including carbohydrases. The work objective is different types of celiac disease (typical, latent, torpid) nutritive correction improvement based on study of small intestine mucous membrane morphofunctional features at different stages of its atrophy, its carbohydrase activity that identifies clinic manifestation features, including nutritional disorders. We suppose, that such phermentopathy correction by means of directional action composites will have a wholesome effect on elimination of different nutritive disorder at celiac disease.
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7.
Randomized phase III clinical trial of five different arms of treatment for patients with cancer cachexia: interim results.
Mantovani, G, Macciò, A, Madeddu, C, Gramignano, G, Serpe, R, Massa, E, Dessì, M, Tanca, FM, Sanna, E, Deiana, L, et al
Nutrition (Burbank, Los Angeles County, Calif.). 2008;(4):305-13
Abstract
OBJECTIVE In April 2005 a phase III randomized study was started to establish which was the most effective and safest treatment of cancer-related anorexia/cachexia syndrome and oxidative stress in improving identified primary endpoints: increase of lean body mass, decrease of resting energy expenditure (REE), increase of total daily physical activity, decrease of interleukin-6 and tumor necrosis factor-alpha, and improvement of fatigue assessed by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). METHODS All patients were given as basic treatment polyphenols plus antioxidant agents alpha-lipoic acid, carbocysteine, and vitamins A, C, and E, all orally. Patients were then randomized to one of the following five arms: 1) medroxyprogesterone acetate/megestrol acetate; 2) pharmacologic nutritional support containing eicosapentaenoic acid; 3) L-carnitine; 4) thalidomide; or 5) medroxyprogesterone acetate/megestrol acetate plus pharmacologic nutritional support plus L-carnitine plus thalidomide. Treatment duration was 4 mo. The sample comprised 475 patients. RESULTS By January 2007, 125 patients, well balanced for all clinical characteristics, were included. No severe side effects were observed. As for efficacy, an interim analysis on 125 patients showed an improvement of at least one primary endpoint in arms 3, 4, and 5, whereas arm 2 showed a significant worsening of lean body mass, REE, and MFSI-SF. Analysis of variance comparing the change of primary endpoints between arms showed a significant improvement of REE in favor of arm 5 versus arm 2 and a significant improvement of MFSI-SF in favor of arms 1, 3, and 5 versus arm 2. A significant inferiority of arm 2 versus arms 3, 4, and 5 for the primary endpoints lean body mass, REE, and MFSI-SF was observed on the basis of t test for changes. CONCLUSION The interim results obtained thus far seem to suggest that the most effective treatment for cancer-related anorexia/cachexia syndrome and oxidative stress should be a combination regimen. The study is still in progress and the final results should confirm these data.
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8.
[Nutritional support of patients with malabsorbtion].
Krums, LM, Sabel'nikova, EA, Parfenov, AI
Eksperimental'naia i klinicheskaia gastroenterologiia = Experimental & clinical gastroenterology. 2007;(3):45-9
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9.
A multimodal perioperative plan for radical cystectomy and urinary intestinal diversion: effects, limits and complications of early artificial nutrition.
Maffezzini, M, Gerbi, G, Campodonico, F, Parodi, D
The Journal of urology. 2006;(3):945-8; discussion 948-9
Abstract
PURPOSE We evaluated the effects of early parenteral and enteral postoperative nutritional support on the restoration of normal bowel function, on the protein depletion that follows cystectomy and on observed complications. MATERIALS AND METHODS Immediate parenteral nutrition was initiated after surgery. It was progressively shifted to the enteral route through a needle catheter jejunostomy inserted at surgery. RESULTS A total of 28 patients with a mean age of 74.2 years (range 55 to 82) were enrolled into the study. Disease was pathologically confined to the bladder in 22 patients, locally advanced in 3 and extravesical in 3. Urinary diversions included an ileocolonic pouch in 15 patients and an orthotopic ileal reservoir in 13. Of the 28 patients 15 (53.6%) completed the protocol, whereas 13 (46.4%) did not. Median time to peristalsis and spontaneous passage of flatus was postoperative day 2 (range 2 to 5) and median time to normal diet resumption was postoperative day 4 (range 3 to 8). No significant differences were observed between patients who completed the protocol and those who did not with regard to the restoration of normal bowel function, and total protein, serum albumin and lymphocyte count. Minor complications were observed in 9 patients and major complications developed in 4. CONCLUSIONS Early postoperative artificial nutrition did not affect the return of bowel function or postoperative protein depletion. Different strategies for more effective nutritional support will be explored in further studies.
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10.
Impact of nutrition support on treatment outcome in patients with locally advanced head and neck squamous cell cancer treated with definitive radiotherapy: a secondary analysis of RTOG trial 90-03.
Rabinovitch, R, Grant, B, Berkey, BA, Raben, D, Ang, KK, Fu, KK, Cooper, JS, ,
Head & neck. 2006;(4):287-96
Abstract
BACKGROUND The aim was to evaluate the relationship between nutrition support (NS) on host toxicity and cancer outcome in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) undergoing definitive radiotherapy (XRT). METHODS We performed a secondary analysis of Radiation Therapy Oncology Group (RTOG) 90-03, a prospective randomized trial evaluating four definitive XRT fractionation schedules in patients with locally advanced HNSCC, which prospectively collected data on NS delivered before treatment (BNS), during treatment (TNS), and after definitive XRT. NS data and pretreatment characteristics of the 1073 evaluable patients were analyzed against therapy toxicity and outcome. RESULTS Patients receiving BNS experienced significantly less weight loss by the end of treatment and less grade 3 to 4 mucositis than patients not receiving BNS. However, patients receiving BNS had a poorer 5-year actuarial locoregional control rate than patients receiving TNS or no NS (29%, 55%, and 57%, respectively, p < .0001) and a poorer 5-year overall survival rate (16%, 36%, and 49%, respectively, p < .0001). Patients receiving BNS were significantly more likely to have a higher T classification, N status, and overall American Joint Committee on Cancer (AJCC) stage and initial presentation with greater pretreatment weight loss, and a poorer Karnofsky Performance Status (KPS) than patients not receiving BNS. After adjusting for the impact of these prognostic factors through a recursive partition analysis, a multivariate analysis with a stratified Cox model found that BNS was still a highly significant independent prognostic factor for increased locoregional failure (hazards ratio [HR], 1.47; 95% confidence interval [CI], 1.21-1.79; p < .0001) and death (HR, 1.41; 95% CI, 1.19-1.67; p < .0001). CONCLUSION In this study, the largest prospective evaluation of nutrition data in treated patients with cancer, BNS was associated with inferior treatment outcome in the patients with HNSCC undergoing XRT. These results should be considered hypothesis generating and encourage prospective clinical research and identification of the mechanisms underlying this finding.