High/low dose dexamethasone with physical activity for cancer-related fatigue in patients with advanced cancer: A phase II randomized double blind study.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 110-110
Author(s):  
Sriram Yennu ◽  
Vicente Valero ◽  
Bora Lim ◽  
Daniel J. Booser ◽  
Carolina Diaz Hernandez ◽  
...  

110 Background: Cancer-related-fatigue (CRF) is the most debilitating symptom in patients with advanced cancer. Physical activity (PA) improves CRF with lower adherence in advanced cancer. Dexamethasone (Dex) improves CRF but has long-term side effects. The purpose of the study was to determine whether a brief course of Dex improves adherence to PA for CRF management. Methods: Advanced cancer patients with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomized to either 4mg of Dex (LoDex) or 8mg of Dex (HiDex) orally BID for 7 days Plus standardized aerobic and resistance exercise for 4 weeks. Change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) fatigue subscale from baseline to Day 8 (primary outcome) and Day 29 were assessed. Secondary outcomes included changes in fatigue (ESAS, PROMIS, MFSI), Sleep Quality (PSQI), fasting blood glucose, and myopathy. Results: Total evaluable patients were 60 (31 LoDex and 29 HiDex arms). The study was feasible (N = 60/67 were evaluable); 84% and 65% LoDex, and 96% and 68% Hi Dex were adherent to aerobic and resistance exercise, respectively [All Patients were adherent to study medication]. There was no significant difference in grade 3+ AE’s between the two arms (P = 0. 92). The FACIT fatigue subscale Cohen’s d in Lo Dex was 0.90 (P < 0.001) and 0.94(P < 0.001); and Hi Dex was 0.86(P < 0.001); and 1.05(P < 0.001) at Day 8 and Day 29, respectively. Similar improvement was found for ESAS Fatigue (P < 0.001), MFSI total (P = 0.005), and PROMIS –fatigue total (P = 0.005). Mixed model analysis showed significant improvement in FACIT-F fatigue scores at Day 8 (P = 0.0006), Day 15 (P = 0.0002), and D (P = 0.0018). There was no significant difference between the two arms at Day 8 and Day 29 in fatigue scores, myopathy, fasting blood glucose levels, symptom distress, and sleep quality scores. Conclusions: Short course of dexamethasone Plus physical activity resulted in sustained and robust improvement in CRF outcomes for upto 3 weeks after discontinuation of steroids suggesting possible priming effects of steroids helped to sustain physical activity. Further larger studies are justified. Clinical trial information: NCT02491632.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.


2021 ◽  
Vol 20 (2) ◽  
Author(s):  
Simon Simon

 ABSTRACTHigh death rate caused by non-transmitted diseases in the world is begun with metabolic syndrome in human beings such the increase in IMT (Body Mass Index) to be obesity, the increase in blood pressure to be hypertension, the increase in blood glucose to be diabetes mellitus, and abnormality of triglycerides, and  HDL cholesterol. Many factors which trigger the indicator abnormality, and of them is bad sleep quality. The research used cross sectional design by analyzing the correlation between sleep quality and 5 metabolic syndrome indicator in female nurses in the operation room of Adam Malik Medan hospital. Sleep quality was measured by using questionnaire of Pittsburg Sleep Quality Index (PSQI), body height and weight were measured to get IMT value, blood pressure was measured by using tensimeter, blood glucose and blood lipid were measured by getting the respondent’s vena blood samples. The data were processed and analysis with independent t-test.The result with independent t-test showed that there was significant difference in IMT (sig=0,003), systolic blood pressure (sig=0,028), and fasting blood glucose content (sig=0,00). However, there was no significant difference in trigliyceride content (sig=0,519), HDL cholesterol content (sig=0,300),). The conclusion was that sleep quality was correlated with three metabolic syndrome indicators: IMT, blood pressure, and blood glucose content, but there was no correlation with trigliyceride and HDL cholesterol.Keywords: Sleep Quality, Metabolic Syndrome , T-Test, 


Author(s):  
Sriram Yennurajalingam ◽  
Vicente Valero ◽  
Zhanni Lu ◽  
Diane D. Liu ◽  
Naifa L. Busaidy ◽  
...  

Background: Despite the high frequency of cancer-related fatigue (CRF) and its debilitating effects on the quality of life of patients with advanced cancer, there are limited treatment options available. Treatments including physical activity (PA) or dexamethasone (Dex) improve CRF; however, they have lower adherence rates (PA) or long-term adverse effects (Dex). The aim of this study was to determine the feasibility of and preliminary results for the combination of PA and Dex in improving CRF. Methods: In this phase II randomized controlled trial, patients with advanced cancer and CRF scores of ≥4/10 on the Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (LoDex arm) or 8 mg of Dex (HiDex arm) twice a day for 7 days. Feasibility and change in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale (FACIT-F) from baseline to day 8 and day 29 (primary outcome) were assessed. Secondary outcomes included changes in fatigue dimensions (FACIT-General, Patient-Reported Outcomes Measurement Information System [PROMIS]-Fatigue). Results: A total of 60 of 67 (90%) patients were evaluable. All patients were adherent to study medication. We found that 84% and 65% of patients in the LoDex arm and 96% and 68% of patients in the HiDex arm were adherent to aerobic and resistance exercise, respectively. The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. We found significant improvements in the Functional Assessment of Cancer Therapy-Physical (P≤.013) and the PROMIS-Fatigue (P≤.003) at days 8 and 29 in both arms. Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). Changes in the FACIT-F scores were not significantly different between patients in the 2 arms (P=.86). Conclusions: Our study found that the combination therapy of PA with Dex was feasible and resulted in the improvement of CRF. The improvement was seen for up to 3 weeks after the discontinuation of Dex. Further larger studies are justified. ClinicalTrials.gov identifier: NCT02491632.


Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 391
Author(s):  
Junhee Ahn ◽  
Youngran Yang

(1) Background: Glycemic control is an effective way to reduce the cardiovascular complications of diabetes. The purpose of this study was to identify the factors associated with poor glycemic control amongst rural residents with diabetes in Korea. (2) Methods: This cross-sectional analysis was conducted amongst a total of 522 participants who had completed baseline health examinations for the Korean Genome and Epidemiology Study (KoGES) Rural Cohort from 2005 to 2011. The subjects were divided into two groups: the good glycemic control group (GCG) (glycosylated hemoglobin (HbA1C) < 7%) and the poor GCG (HbA1C ≥ 7%). Logistic regression was used to examine the role of sociodemographics, health-related behavior, comorbidity and diabetes-related and clinical factors in poor glycemic control amongst rural residents with diabetes. (3) Results: In total, 48.1% of participants were in the poor GCG. Poor GCG was significantly associated with drinking (odds ratio (OR) = 0.42, 95% CI = 0.24–0.71), lack of regular physical activity (OR = 1.68, 95% CI = 1.03–2.76), fasting blood glucose (FBG) > 130 mg/dL (OR = 7.80, 95% CI = 4.35–13.98), diabetes for > 7 years (OR = 1.79, 95% CI = 1.08–2.98), cholesterol ≥ 200 mg/dL (OR = 1.73, 95% CI = 1.05–2.84) and positive urine glucose (OR = 6.24, 95% CI = 1.32–29.44). (4) Conclusion: Intensive glucose control interventions should target individuals amongst rural residents with diabetes who do not engage in regular physical activity, have been diagnosed with diabetes for more than seven years and who have high fasting-blood glucose, high cholesterol levels and glucose-positive urine.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.


2019 ◽  
Vol 9 (1) ◽  
pp. 86 ◽  
Author(s):  
Zulkarni Zulkarni

This Research was conducted to determine the effect of ethanol extract from red chilli (Capsicum annuum L)in lowering blood glucose levels of hyperglycemic male white mices. This study used 30 malewhitemices and divided into 6 groups: negative control group, the positive control group, the treatmentgroup withdosage of 200 mg / kgweight, 400 mg / kgwieght, 600 mg / kg weight and a comparison group with glibenclamide with dosage of 5 mg / kgweightadministered orally for 21 days. The level of fasting blood glucose was checked 6 days after dexamethasone induced, and after the ethanol extract of red chilies on day 7th, 14th, and 21st. The data was analyzed statistically with one –way and two-way Anova by usingSPSS16 program and proceed with the test Duncan to look the significant difference between treatments. The results showed that the ethanol extract from red chilies with a dosage of 200mg / kgweight, 400mg / kgweight, 600 mg / kgweight showed the effect in lowering blood sugar levels in male white mices hyperglycemia significantly (p <0.05). The duration ethanol extract of red chili affected blood glucose levels. The most effective duration in lowering blood glucose levels is the administration of a preparation within 21 days.


Diabetes Care ◽  
2006 ◽  
Vol 29 (12) ◽  
pp. 2598-2604 ◽  
Author(s):  
G. N. Healy ◽  
D. W. Dunstan ◽  
J. E. Shaw ◽  
P. Z. Zimmet ◽  
N. Owen

2020 ◽  
Author(s):  
Reema M Al Jalal ◽  
Alaa I. Ibrahim ◽  
Turki S. Abualait

Abstract Background Child development has critical links to his ability to see and hear. When these senses are impaired, everything is impacted. The aim of this study was to investigate the effect of visual and hearing impairments on physical activity and sleep quality in a comparison with the normal sighted-hearing children. Methods This cross-sectional study included 60 Saudi children (20 blind, 20 sensorineural deaf, and 20 sighted-hearing) aged 10 to 15 years old. The physical activity levels and sleep quality were assessed using a waist-mounted ActiGraph accelerometer. Results Children with sensorineural deafness were significantly more active (in step rate and activity rate) than the sighted-hearing group (p = 0.05 and 0.003, respectively). Sighted-hearing children and children with blindness had significantly more sedentary time than children with sensorineural deafness (p = 0.004 and 0.03, respectively). Sleep efficiency was significantly higher in children with sensorineural deafness than sighted-hearing children (p = 0.02). No significant difference was recorded in any of the sleep parameters when children with blindness were compared to the sighted-hearing or children with sensorineural deafness (p > 0.05). Conclusions The ActiGraph results revealed that children with sensorineural deafness were significantly more active and with higher sleep efficiency than sighted-hearing children. Children with blindness spent more time in sedentary activities and less time in moderate activities than children with sensorineural deafness. There was no significant difference in sleep efficiency when comparing sensorineural deaf and blind children.


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