Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
Ontology highlight
ABSTRACT:
DISEASE(S): Fatigue,Neoplasms,Cancer
PROVIDER: 2149872 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die from colorectal cancer each year. The third leading cause of death is colorectal cancer in Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). Previous studies have reported that cancer-related fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it can occur during treatment, in advanced disease and in disease-free survivors; the prevalence of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of CRF as ‘’a persistent subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and that significantly interferes with usual functioning." Besides, CRF could dynamically change with the interactions among disease progression, treatment regimen, tumor site, nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer patients, more in-depth researches on CRF are needed.
The aim of this longitudinal study is to examine the dynamic changes, correlated factors and QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the results will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.
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Project description:This study was the first randomized controlled trial to test if mind-body interventions can improve self-regulation in prisoners with different personality disorders, using a combination of gene expression, neural, and behavioral measures.Thirty prisoners with personality disorders who score high on psychopathy were assigned to a mindfulness intervention (n=10), a yoga intervention (n=10), or a wait-list control group (n=10) using stratified random sampling. Both mindfulness and yoga interventions were held at the same time and lasted three hours per day on five consecutive days. At baseline and after the intervention, we measured inflammation-related gene expression; resting state brain activit with electroencephalography (EEG); risk-taking and attention with cognitive tasks; event-related potentials (ERPs) related to the attention task; and stress, emotion regulation and mindfulness with questionnaires. We expected that both yoga and mindfulness would improve self-regulation (i.e., executive attention, emotion regulation and self-awareness), reduce stress and risk-taking behavior, downregulate inflammatory-related gene expression and increase alpha and theta power. Blood was collected for the analysis of changes in gene expression of 38 genes related to inflammation and the immune system (IL-1 signaling pathway). Venipuncture samples were collected into 10ml EDTA tubes, lysed and frozen at -80°C. Peripheral blood mononuclear cells were isolated by density gradient centrifugation. Ribonucleic acid (RNA) was extracted (QiaAmp RNA Blood Mini kit; Qiagen) and tested for suitable mass and integrity (NanoDrop One, Acclaro Sample Intelligence; Thermo Scientific). RNA was then converted to fluorescent cRNA for hybridization to IL-1 signaling pathway plate H96 (Bio-Rad Labs Ltd, UK). Gene expression data were expressed as cycle threshold (CT) values by calculating 2−ΔΔCT, and referencing to the geomean of all genes because endogenous control genes that are supposed to have constant levels of expression were not stable in this case. After normalizing 2−ΔΔCT to the wait-list control group median, the data were imported into SPSS and analyzed by group allocation based on change scores of each normalized 2−ΔΔCT. Intent-to-treat (ITT) principles were used for all the analyses. Post-intervention missing data was handled by running multiple imputations. A p-value of <0.05 was considered significant and Bonferroni correction was implemented to adjust for multiple comparisons (i.e., <.02 was considered significant in individual 2-group comparisons). The data were analyzed with the IBM SPSS 24.0 software (Statistical Package for Social Sciences, SPSS Inc., 237 Chicago, IL). The effectiveness of interventions was tested by calculating changes scores and running non-parametric Kruskal-Wallis test for K independent samples because the assumptions for ANOVA were not met. If there was a significant difference detected, it was followed with Mann-Whitney U test 240 and Kolmogorov-Smirnov Z test to determine specific group differences. Additionally, eta squared was used as a measure of effect size to determine the proportion of variability in outcomes that can be explained by group membership.We found no significant changes in gene expression or any other measures.
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Project description:Cancer-related fatigue is one of the most frequent complaints among breast cancer survivors, with a major negative impact on general life. However, the etiology behind this syndrome is still unraveled. Gene expression analysis was performed on whole blood samples from breast cancer survivors classified as either fatigued or non-fatigued at two consecutive time points. The analysis identified several gene sets concerning plasma and B cell pathways as different between the fatigue and non-fatigue groups, suggesting that a deregulation in these pathways might underlie the fatigue syndrome. The fatigue group also showed a higher mean level of leucocytes, lymphocytes and neutrophiles compared with the non-fatigue group, thus further implicating the immune system in the biology behind the fatigue syndrome. Keywords: Blood RNA and late side effects Breast cancer survivors treated with adjuvant radiotherapy at The Norwegian Radium Hospital between 1998 and 2002 were invited to participate in a study assessing late treatment effects in breast cancer survivors. In the present study, gene expression analysis was performed on whole blood samples from breast cancer survivors with and without persistent fatigue, to look for different expression patterns that might shed light on the biology behind cancer-related fatigue.
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