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Background and aims: Although many cancer patients suffer from malnutrition or cancer cachexia, there is no standard of care so far due to limited intervention trials. Pooled data from two combined trials were analyzed regarding nutritional status and survival time. Materials and methods: Data from two trials with advanced cancer patients were included. In both trials, patients in the intervention group received at least three times nutritional counseling and supervised training sessions. Patients in the control group continued being treated according to usual care. Nutritional status was measured using BMI, body composition and handgrip strength. Survival time was analyzed using the Cox proportional hazard model with the period between the beginning of the trial and death as underlying time scale. Results: 68 men (61.8%) and 42 women (38.2%) were randomized either to the intervention (n = 56) or the control (n = 54) group. The inter-group difference for changes in BMI and body composition was not statistically significant after 3 months. Handgrip strength improved significantly from 34.4 ± 10.2 kg to 36.3 ± 9.9 kg at 3 months in the intervention compared to 33.9 ± 9.2 kg to 34.9 ± 9.1 kg in the control group (p = 0.006). The analysis of survival time showed no inter-group difference for all patients. A detailed analysis for different diagnoses showed that in patients with lung cancer, the covariates "CRP value," "days from first diagnosis to randomization" as well as "gender" were significantly associated with survival time. Patients with higher CRP value had a shorter survival time and female patients had a shorter survival time than male patients in our analysis. In addition, patients with pancreatic cancer randomized to the control group had a 20% shorter survival time than those in the intervention group (p = 0.048). Conclusion: The pooled analysis showed a significant improvement of handgrip strength in advanced cancer patients through the implementation of a combined therapy. Handgrip strength is of prognostic significance in hospitalized patients due to its association with mortality and morbidity. However, no improvements in further tests were detected. There is great need for further investigations examining the effect of nutritional and exercise therapy on survival time with focus on different cancer diagnoses.
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BACKGROUND & AIMS: Branched-chain amino acids and specifically leucine stimulate protein synthesis and may overcome an anabolic resistance in malnourished and cachectic cancer patients. Therefore, we hypothesized that the addition of a leucine-rich supplement to a multimodal therapy improves physical function in advanced cancer patients. METHODS: This single center, randomized trial examined a multimodal therapy over 12 weeks in patients with advanced cancer. The intervention group received a leucine-rich supplement in combination with a nutrition and physical exercise program. Patients in the control group received standard care. Primary endpoint was physical function measured with the short physical performance battery (SPPB). Secondary endpoints were further physical performance tests, nutritional status, dietary intake, fatigue, quality of life (QoL) and clinical course. All parameters were evaluated at baseline, after three and at six months. RESULTS: 23 women and 29 men with an average age of 63.1 ± 10.3 (range 30-81) years and BMI of 25.4 ± 4.7 kg/m2 were randomized either to the intervention (n = 27) or control (n = 25) group. Patients in the intervention group joined a mean of 28.4 ± 7.4 training sessions (78.8%), 3.2 ± 0.6 nutritional counselling sessions (106.7%) and consumed on average 85.4 ± 33.2 supplements (71.2%). Inter-group comparison showed no significant difference in the primary endpoint SPPB after three (p = 0.184, 95% CI: -1.43, 0.29) and six months (p = 0.986, 95% CI: -0.87, 0.89). However, the secondary endpoint handgrip strength improved significantly from 35.8 ± 9.8 kg at baseline to 37.6 ± 10.0 kg at three months in the intervention group compared to 35.7 ± 8.8 kg at baseline to 34.0 ± 10.1 kg at three months in the control group (p < 0.001, 95% CI: -6.03, -1.97). The inter-group difference for changes in the further secondary endpoints nutritional status, dietary intake, fatigue, QoL and clinical course showed a trend towards an improvement in the intervention group, however, the differences were not significant after three and six months. CONCLUSIONS: The present trial demonstrated a good adherence to the multimodal therapy as well as a significant improvement of handgrip strength in patients with advanced cancer. In addition, the clinical course data underlined the safety of the program. However, we failed to show significant improvements in further physical performance tests, especially our primary outcome factor SPPB as well as nutritional status, fatigue or QoL.
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Caquexia/terapia , Suplementos Nutricionais , Terapia por Exercício/métodos , Leucina/administração & dosagem , Neoplasias/terapia , Terapia Nutricional/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Caquexia/etiologia , Caquexia/fisiopatologia , Terapia Combinada , Exercício Físico , Teste de Esforço , Fadiga , Feminino , Força da Mão , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/fisiopatologia , Estado Nutricional , Cooperação do Paciente , Desempenho Físico Funcional , Qualidade de Vida , Resultado do TratamentoRESUMO
Purpose To quantify liver fat and liver iron content by measurement of confounder-corrected proton density fat fraction (PDFF) and R2* and to identify clinical associations for fatty liver disease and liver iron overload and their prevalence in a large-scale population-based study. Materials and Methods From 2008 to 2013, 2561 white participants (1336 women; median age, 52 years; 25th and 75th quartiles, 42 and 62 years) were prospectively recruited to the Study of Health in Pomerania (SHIP). Complex chemical shift-encoded magnetic resonance (MR) examination of the liver was performed, from which PDFF and R2* were assessed. On the basis of previous histopathologic calibration, participants were stratified according to their liver fat and iron content as follows: none (PDFF, ≤5.1%; R2*, ≤41.0 sec-1), mild (PDFF, >5.1%; R2*, >41 sec-1), moderate (PDFF, >14.1%; R2*, >62.5 sec-1), high (PDFF: >28.0%; R2*: >70.1 sec-1). Prevalence of fatty liver diseases and iron overload was calculated (weighted by probability of participation). Clinical associations were identified by using boosting for generalized linear models. Results Median PDFF was 3.9% (range, 0.6%-41.5%). Prevalence of fatty liver diseases was 42.2% (1082 of 2561 participants); mild, 28.5% (730 participants); moderate, 12.0% (307 participants); high content, 1.8% (45 participants). Median R2* was 34.4 sec-1 (range, 14.0-311.8 sec-1). Iron overload was observed in 17.4% (447 of 2561 participants; mild, 14.7% [376 participants]; moderate, 0.8% [20 participants]; high content, 2.0% [50 participants]). Liver fat content correlated with waist-to-height ratio, alanine transaminase, uric acid, serum triglycerides, and blood pressure. Liver iron content correlated with mean serum corpuscular hemoglobin, male sex, and age. Conclusion In a white German population, the prevalence of fatty liver diseases and liver iron overload is 42.2% (1082 of 2561) and 17.4% (447 of 2561). Whereas liver fat is associated with predictors related to the metabolic syndrome, liver iron content is mainly associated with mean serum corpuscular hemoglobin. © RSNA, 2017 Online supplemental material is available for this article.