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Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.

ABSTRACT: OBJECTIVE:Advanced cancer patients frequently experience debilitating symptoms that occur in clusters, but few pharmacological studies have targeted symptom clusters. Our objective was to examine the effects of dexamethasone on symptom clusters in patients with advanced cancer. METHODS:We reviewed the data from a previous randomized clinical trial to determine the effects of dexamethasone on cancer symptoms. Symptom clusters were identified according to baseline symptoms by using principal component analysis. Correlations and change in the severity of symptom clusters were analyzed after study treatment. RESULTS:A total of 114 participants were included in this study. Three clusters were identified: fatigue/anorexia-cachexia/depression (FAD), sleep/anxiety/drowsiness (SAD), and pain/dyspnea (PD). Changes in severity of FAD and PD significantly correlated over time (at baseline, day 8, and day 15). The FAD cluster was associated with significant improvement in severity at day 8 and day 15, whereas no significant change was observed with the SAD cluster or PD cluster after dexamethasone treatment. CONCLUSION:The results of this preliminary study suggest significant correlation over time and improvement in the FAD cluster at day 8 and day 15 after treatment with dexamethasone. These findings suggest that fatigue, anorexia-cachexia, and depression may share a common pathophysiologic basis. Further studies are needed to investigate this cluster and target anti-inflammatory therapies.

SUBMITTER: Yennurajalingam S

PROVIDER: S-EPMC4786346 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.

Yennurajalingam Sriram S Williams Janet L JL Chisholm Gary G Bruera Eduardo E

The oncologist 20160217 3

<h4>Objective</h4>Advanced cancer patients frequently experience debilitating symptoms that occur in clusters, but few pharmacological studies have targeted symptom clusters. Our objective was to examine the effects of dexamethasone on symptom clusters in patients with advanced cancer.<h4>Methods</h4>We reviewed the data from a previous randomized clinical trial to determine the effects of dexamethasone on cancer symptoms. Symptom clusters were identified according to baseline symptoms by using ...[more]

PMID: 26888692

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Project description:BACKGROUND:There is limited research in advanced cancer patients (ACP) regarding association between objectively measured daytime activity and sleep (as measured by actigraphy), patient characteristics, and cancer symptoms (fatigue, sleep, anxiety, depression, cachexia, and symptom distress scores [SDSs]). OBJECTIVES:Our aim of the study was to determine the association between mean daytime activity (MDTA) and the following items: fatigue (FACIT-F), SDSs (Edmonton Symptom Assessment Scale [ESAS]), sleep quality (Pittsburg Sleep Quality Index [PSQI]), objective sleep variables (OSV) (sleep onset, sleep efficacy, wake after sleep onset, total sleep time), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), body composition scores, and overall survival (OS). We also examined the association between sleep [PSQI and OSV scores] and FACIT-F, HADS, and ESAS. METHODS:Secondary analysis of a recent clinical trial of cancer-related fatigue in advanced cancer (NCT00424099). Association between MDTA and OSV (measured by actigraphy) during the first week of the study and patient characteristics, symptoms (FACIT-F, ESAS, HADS, and PSQI), and OS were analyzed. RESULTS:Seventy-nine eligible patients were evaluable. The median age was 57 years. Median MDTA was 248.43 counts/minute. Multivariate analysis shows that low MDTA was significantly associated with age, gender, Functional Assessment of Cancer Therapy (FACT)-Functional Well-Being (FWB), ESAS dyspnea, HADS-anxiety, and total sleep time. MDTA was not associated with FACIT-F (p?=?0.997) and OS (p?=?0.18). Sleep quality (PSQI) was significantly associated with FACIT-F, HADS, ESAS anxiety, and depression, but none of these variables was associated with OSV. CONCLUSION:In ACP, lower MDTA was significantly associated with age, gender, FACT-FWB, ESAS dyspnea, HADS-anxiety, and total sleep time. Both sleep quality and cancer-related fatigue scores were strongly associated with depression and anxiety. More research is needed.

Project description:BACKGROUND:Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. METHODS:In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. RESULTS:A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). CONCLUSIONS:In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).

Project description:BackgroundSymptom monitoring interventions enhance patient outcomes, including quality of life (QoL), health care utilization, and survival, but it remains unclear whether older and younger patients with cancer derive similar benefits. We explored whether age moderates the improved outcomes seen with an outpatient electronic symptom monitoring intervention.Patients and methodsWe carried out a secondary analysis of data from a randomized trial of 766 patients receiving chemotherapy for metastatic solid tumors. Patients received an electronic symptom monitoring intervention integrated with oncology care or usual oncology care alone. The intervention consisted of patients reporting their symptoms, which were provided to their physicians at clinic visits, and nurses receiving alerts for severe/worsening symptoms. We used regression models to determine whether age (older or younger than 70 years) moderated the effects of the intervention on QoL (EuroQol EQ-5D), emergency room (ER) visits, hospitalizations, and survival outcomes.ResultsEnrollment rates for younger (589/777 = 75.8%) and older (177/230 = 77.0%) patients did not differ. Older patients (median age = 75 years, range 70-91 years) were more likely to have an education level of high school or less (26.6% versus 20.9%, P = 0.029) and to be computer inexperienced (50.3% versus 23.4%, P < 0.001) compared with younger patients (median age = 58 years, range 26-69 years). Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care. However, older patients did not experience significantly lower risk of ER visits (HR = 0.90, P = 0.613) or improved survival (HR = 1.06, P = 0.753) with the intervention. We found no moderation effects based on age for QoL and risk of hospitalizations.ConclusionsAmong patients with advanced cancer, age moderated the effects of an electronic symptom monitoring intervention on the risk of ER visits and survival, but not QoL. Symptom monitoring interventions may need to be tailored to the unique needs of older adults with cancer.

Dataset Information

Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.

Publications

Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.

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