Effect of Rosuvastatin in Preventing Chemotherapy-Induced Cardiotoxicity in Women With Breast Cancer: A Randomized, Single-Blind, Placebo-Controlled Trial

2019 ◽  
Vol 24 (3) ◽  
pp. 233-241 ◽  
Author(s):  
Maryam Nabati ◽  
Ghasem Janbabai ◽  
Jamil Esmailian ◽  
Jamshid Yazdani
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Tissue Doppler ◽  
Chemotherapeutic Agents ◽  
Left Ventricular ◽  
Significant Difference ◽  
To Receive ◽  
Single Blind

Objective: Chemotherapy-induced cardiotoxicity is a major and leading cause of death in breast cancer survivors. It can present decades after chemotherapy and can manifest in different ways; some chemotherapeutic agents have a powerful dose-dependent relationship with cardiotoxicity. The aim of this study was to investigate the effect of rosuvastatin on preventing chemotherapy-induced cardiotoxicity in patients with breast cancer. Methods: Our study was a randomized, single-blind, placebo-controlled trial that involved 89 women with newly diagnosed breast cancer who were scheduled to receive chemotherapy. Patients were randomly assigned to receive rosuvastatin or a placebo in a 1:1 ratio for 6 months. Echocardiography, using 2-dimensional (2D) Doppler, tissue Doppler, and speckle-tracking methods, was used to determine the absolute changes in the left ventricular systolic ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left atrial (LA) diameter, transmitral Doppler early diastolic velocity (E wave), tissue Doppler early diastolic (e′) and peak systolic (s′) mitral annular velocities, E/e′ ratio, and global longitudinal systolic strain. Results: The LVEF was significantly reduced in the placebo group at the end of the study when compared with the baseline value. However, there was no significant difference in the LVEF in the intervention group (intergroup P = .012). Furthermore, compared with the intervention group at the end of the study, there was a significant increase in the 4- and 2-chamber LVESV, LA diameter, and E/e′ ratio in the placebo group (intergroup P = .019, P = .024, P < .001, and P = .021, respectively) and a significant decrease in the e′ and s′ velocities in the placebo group (intergroup P < .001 and P < .006, respectively). Conclusions: The present study showed that the prophylactic use of rosuvastatin may prevent the development of chemotherapy-induced cardiotoxicity.

scholarly journals Role of nebivolol in anthracycline-induced cardiotoxicity

2019 ◽  
Vol 7 (12) ◽  
pp. 4677
Author(s):  
John Satish Rudrapogu ◽  
Biju Govind ◽  
Adinarayana Unnagiri
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
2D Echocardiography ◽  
To Receive

Background: Anthracyclines are extensively used in the treatment of breast cancer. However, these therapeutic agents are responsible for chemotherapy-induced cardiotoxicity. Aim of this study was to assess the effect of use of prophylactic nebivolol for the prevention of anthracycline-induced cardiotoxicity in breast cancer patients.Methods: This was a prospective, randomized, single-blind, and placebo-controlled trial involving 80 participants with breast cancer, scheduled to undergo chemotherapy with doxorubicin. Patients were randomly divided into two groups: the nebivolol group (n=40) to receive nebivolol 5 mg daily and the placebo group (n=40) to receive placebo. All patients were evaluated with baseline Electrocardiogram (ECG) and echocardiography prior to treatment, and at the 6-month follow-up. Echocardiography included 2D echocardiography, colour doppler and tissue doppler imaging.Results: The study groups had comparable baseline echocardiographic variables. At the 6-month echocardiographic follow-up, there were no changes of statistical significance in any 2D echocardiographic variables in either group. However, there were minimal reductions of 0.4% in left ventricular ejection fraction in the nebivolol group (62.2±4.4% to 61.9±4.2%, p=0.75) and 1.6% in the placebo group (62.8±3.6% to 61.8±3.2%, p=0.18). Doppler examinations also did not reveal any statistically significant changes in variables such as peak A velocity, peak E velocity, E/A ratio, isovolumic relaxation time, and isovolemic contraction time in either group.Conclusions: Prophylactic use of nebivolol treatment may possess cardioprotective properties against anthracycline-induced cardiotoxicity in breast cancer patients although not statistically significant in this study.

scholarly journals Laser Acupuncture for Relieving Nausea and Vomiting in Pediatric Patients Undergoing Chemotherapy: A Single-Blind Randomized Clinical Trial

2018 ◽  
Vol 36 (1) ◽  
pp. 44-54 ◽  
Author(s):  
Cristiane da Silva Varejão ◽  
Fátima H. do Espírito Santo
Keyword(s):  
Placebo Group ◽  
Children And Adolescents ◽  
Intervention Group ◽  
Nausea And Vomiting ◽  
Laser Acupuncture ◽  
Placebo Acupuncture ◽  
Significant Difference ◽  
Group A ◽  
The City ◽  
Single Blind

Nausea and vomiting are frequent side effects associated with chemotherapy treatments. The aim of this study was to evaluate the efficacy of laser acupuncture in relieving nausea and vomiting in children and adolescents undergoing laser treatment. This is an experimental, randomized, single-blind study. The research was carried out at the INCA (Instituto Nacional de Câncer), a reference institution in the control and treatment of cancer, located in the city of Rio de Janeiro, Brazil. The research project was approved by the INCA Research and Ethics Committee under Registration No. 164/14 and CAAE 3374551.0.3001.5274. Children and adolescents between the ages of 6 and 17 years who were undergoing chemotherapy with drugs of high and medium degrees of emetogenic toxicity were selected. The participants were divided into two groups, A and B. In A, the active acupuncture was applied, and in B, the placebo acupuncture was applied. Analysis of the data indicated that there was significant relief from nausea in the intervention group when compared with the placebo group. A decrease in the number of episodes of vomiting on the second and third days of chemotherapy was also observed. On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group. The study concluded that laser acupuncture was effective in relieving nausea within 5 days of chemotherapy and in reducing the number of episodes of vomiting on Days 2 and 3 after chemotherapy.

Effect of acupressure on post tonsillectomy pain in adolescents: a randomized, single-blind, placebo-controlled trial study

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Somaye Pouy ◽  
Abolfazl Etebarian Khorasgani ◽  
Ali Azizi-Qadikolaee ◽  
Yasaman Yaghobi
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Significant Difference ◽  
The World ◽  
Before And After ◽  
Positive Effect ◽  
Single Blind

Abstract Introduction Tonsillectomy is one of the most common pediatric surgeries in the world and pain control following tonsillectomy is very important. Objective The aim of this study is to investigate the effect of acupressure on the amount of pain following tonsillectomy in children. Method One hundred and forty-four children aged 5–12 years old were assigned into one of three groups: interventions, control and placebo. In the intervention group, acupressure was applied at three acupoints and in the placebo group, sham acupressure was applied. In the control group routine care only was applied. Results There was a significant difference between an average of changes in pain score before and after the intervention during the 3 time periods after the tonsillectomy operation in the acupressure group (p = 0.002). Conclusion The results showed that acupressure had a positive effect on pain reduction after tonsillectomy in children in the intervention group.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

Development and Evaluation of Culturally Tailored Mobile Phone-Based Application to Promote Breast Cancer Preventive Behaviors among the Iranian Women: A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Maryam Khazaee-Pool ◽  
Tahereh Pashaei ◽  
Koen Ponnet
Keyword(s):  
Breast Cancer ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Iranian Women ◽  
Preventive Behaviors ◽  
Randomized Controlled ◽  
Culturally Tailored ◽  
To Receive ◽  
Promote Breast Cancer

BACKGROUND Despite the first rank of breast cancer incidence diagnosed in Iranian women, they have one of the lowest rates of breast cancer preventive behaviors. So that these behaviors have not been applied as routine care for healthy Iranian women. To improve preventive behaviors, a reliable and practical approach is needed. This study aimed to develop and test the culturally tailored mobile Phone-based application to promote breast cancer preventive behaviors called ASSISTS among Iranian women. OBJECTIVE This study explores the impact of ASSISTS mobile application on changes to study Iranian women’ preventive behaviors toward breast cancer and recommends suggestions for how the intervention can be enhanced for varied dissemination and performance in the Iranian community. METHODS Applying a randomized controlled trial design, 140 Iranian women aged 40 years and above were recruited and randomly appointed to either the intervention group (n=70) to receive culturally and personally tailored multilevel messages by a smartphone application accompanied by the routine health care facilities and control group (n=70) to receive just a routine health care. Outcome measures included attitude, stimulus, self-efficacy, information seeking, stress management, self-care, and social support, readiness for performing breast cancer preventive behaviors. The feasibility and acceptability of the ASSISTS mobile application intervention were also assessed. RESULTS Significant intervention effects were observed for objectively measured knowledge and self-reported variables of ASSISTS scale (all P<.05). The intervention group indicated significantly more change on scores of knowledge of preventive behaviors procedures and self-care (P=.01). The ASSISTS app group indicated significantly more readiness for breast exams use after the intervention compared with the booklet group. Furthermore, the intervention group evaluated consent with the intervention (P=.001) and increase of knowledge on breast cancer preventive behaviors (P=.001) more significant than the booklet group. About 68.2% ASSISTS app participants assessed this app as self-explanatory (44/70), fun (64/70, 66.5%), and interesting (63/70, 88.8%). CONCLUSIONS An ASSISTS smartphone app-based intervention was a practical, useful, and suitable intervention means to improve breast cancer preventive behaviors in Iranian women. A flexible, directly tailored method that depends on current technical progress can gain underserved and hard-to-employee populations that bear unequal cancer loads.

scholarly journals A Randomized Controlled Trial Comparing Two Doses of Caffeine for Apnoea in Prematurity

2021 ◽  
Vol 18 (9) ◽  
pp. 4509
Author(s):  
Anis Munirah Mohd Kori ◽  
Hans Van Rostenberghe ◽  
Nor Rosidah Ibrahim ◽  
Najib Majdi Yaacob ◽  
Ariffin Nasir
Keyword(s):  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Duration Of Treatment ◽  
Significant Difference ◽  
To Receive ◽  
Higher Doses ◽  
Methyl Xanthine

Caffeine is the most commonly used methyl xanthine for the prevention of apnoea in prematurity, but the ideal dose was uncertain, until now. This study compared two doses of caffeine for the prevention of apnoea in prematurity. A clinical trial was conducted on 78 preterm infants ≤32 weeks in Neonatal Intensive Care Unit. They were randomly allocated to receive the intervention (loading 40 mg/kg/day and maintenance of 20 mg/kg/day) or the control (loading 20 mg/kg/day and maintenance of 10 mg/kg/day) dose of caffeine. The primary outcome of the study was the frequency and total days of apnoea per duration of treatment for both groups. The frequency of apnoea ranged from zero to fourteen in the intervention group and zero to twelve in the control group. There was no statistically significant difference between the groups, with a p-value of 0.839. The number of days of apnoea was also similar between both groups, with a p-value of 0.928. There was also no significant difference in adverse events between both regimens. This study did not support the use of higher doses of caffeine as a prevention for apnoea in prematurity.

scholarly journals Effectiveness of escitalopram in the reduction of pain, anxiety, and depression in patients with breast cancer: A randomized single-blind controlled trial

2021 ◽  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Depression Score ◽  
Anxiety And Depression ◽  
Personality Factors ◽  
Control Group ◽  
Pain Anxiety ◽  
Significant Difference ◽  
Reduction Of Pain ◽  
Single Blind

Background: Pain, anxiety, and depression are common but often neglected problems in patients with cancer. Objectives: Considering the importance and impact of anxiety and depression as common psychiatric symptoms in people with cancer, the present study aimed to assess the effectiveness of escitalopram in the reduction of pain, anxiety, and depression in patients with breast cancer. Methods: This single-blind controlled trial was conducted on 32 patients diagnosed with breast cancer who were referred for modified radical mastectomy (2018-2019). The intervention group received daily oral capsules containing 10 milligrams of escitalopram for four weeks, while the control group received placebo capsules containing starch on a daily basis. Hospital Anxiety and Depression Scale (HADS) and Visual Analogue Scale were administered to the patients at the commencement of the study and four weeks after the intervention. In addition, at baseline examination, personality factors were assessed by the NEO Five-Factor Inventory-3 questionnaire. Results: Based on the results, the scores of HADS anxiety, total HADS, and pain reduced after the intervention in the case group; however, the HADS depression score demonstrated a slight increase. A significant difference was observed between the case and control groups for HADS anxiety score after the intervention (P=0.01). The correlation of personality characteristics with HADS anxiety and depression subscales pointed out a significant negative correlation between the HADS depression score and conscientiousness (r=-0.40; P<0.05). Conclusion: Due to minor side effects of escitalopram, this drug is suggested to be used for the reduction of anxiety symptoms and pain intensity in patients with breast cancer.

The Efficacy of Omega-3 Supplement on Prevention of Retinopathy of Prematurity in Premature Infants: A Randomized Double-blinded Controlled trial

2018 ◽  
Vol 24 (17) ◽  
pp. 1845-1848 ◽  
Author(s):  
Nasrin Khalesi ◽  
Arash Bordbar ◽  
Nastaran Khosravi ◽  
Morteza Kabirian ◽  
Alireza Karimi
Keyword(s):  
Placebo Group ◽  
Birth Weight ◽  
Premature Infants ◽  
Gestational Age ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Omega 3 ◽  
Significant Difference ◽  
Double Blinded

Background: The present study aimed to assess the efficacy of omega-3 in treating ROP in premature infants. Methods: This randomized double-blinded controlled trial was performed on 160 premature infants with gestational age lower than 32 weeks and birth weight < 1500 grams who were at risk of ROP development (Tehran, Iran-2013). Children were randomly assigned to two groups. The intervention group received 300 mg omega-3 daily and the control group received sterile water as the placebo. The severity of ROP was defined according to the International Classification of ROP. Results: The frequency of ROP was 7.5% in the group received omega-3 and 20.0% in the placebo group with a significant difference (p = 0.021). Regarding the severity of ROP in the intervention group, ROP grade I was found in two patients and ROP grade II in four patients; while ROP grade I, II, and III were revealed in 6, 6, and 4 patients in placebo group indicating a significant difference between the two groups (p = 0.001). Using the multivariate logistic regression modeling with the presence of gender, gestational age, and birth weight, the use of omega-3 was associated with reduced risk for ROP (p = 0.045). Conclusion: The use of omega-3 supplement can be an appropriate treatment option for the treatment of ROP in premature infants.

Does Mindfulness Training Affect Rumination in Women with Breast Cancer?

2020 ◽  
Author(s):  
Razieh Bagherzadeh ◽  
Rezvan Sohrabinezhad ◽  
Tayebeh Gharibi ◽  
Farkhondeh Mehbodi ◽  
Hakimeh Vahedparast
Keyword(s):  
Breast Cancer ◽  
Stress Responses ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mindfulness Training ◽  
Trial Registration ◽  
Control Group ◽  
Significance Level ◽  
Significant Difference

Abstract Background: Cancers cause not only physical and social impairments but also psychological stress responses such as rumination, which require more attention from researchers as well as clinicians.Aim: This study aimed to investigate the effect of mindfulness training on rumination in women with breast cancer.Method: This randomized controlled trial was performed on 46 women with breast cancer in Bushehr city (2018). Subjects were randomly assigned to two intervention and control groups. The intervention was 8 sessions of group mindfulness training. A rumination questionnaire was administered before the intervention, immediately, and one month after the intervention. The data were analyzed by analytical tests at the 0.05 significance level.Results: There was no significant difference between the rumination scores of the intervention group at the three stages of measurement. For the control group, the mean rumination scores at the posttest and follow-up stages were both significantly higher than the pretest score (P <0.001). Also, the follow-up mean rumination score of the control group was significantly higher than that posttest (P=0.02). Comparison of the two groups where adjusted for baseline, showed a significant difference between the two groups in terms of mean rumination score at the posttest stage (P=0.01) and at the follow-up stage (P<0.001).Conclusion: Subjects in the intervention group were more successful in avoiding increasing rumination than those in the control group, an ability that must be attributed to the effect of mindfulness training. Still, further research is needed to determine whether longer interventions will be able to reduce rumination.Trial registrationTrial registration number: IRCT20090522001930N2 Date: 2018-08-08

scholarly journals Effects of Melatonin on Postoperative Delirium After PCI in Elderly Patients: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 24 (5) ◽  
pp. E893-E897
Author(s):  
Yicheng Shi
Keyword(s):  
Placebo Group ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Assessment Method ◽  
Double Blind ◽  
Significant Difference ◽  
Hospitalization Costs ◽  
To Receive

Background: Experimental evidence has indicated the benefits of melatonin (Mel) for the treatment of delirium. Clinical trials had no definite conclusions concerning Mel on delirium after percutaneous transluminal coronary intervention (PCI) in elderly patients. The present study explored whether acute Mel treatment could reduce the incidence of delirium. Methods: This trial enrolled patients over the age of 60, who were admitted to intensive care units (ICUs) after PCI. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive Mel (3 mg/day) or placebo once daily for up to 7 days. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method (CAM) during the first 7 postoperative days. Analyses were performed using intention-to-treat and safety populations. Results: A total of 297 patients randomly were assigned to receive either placebo (N = 149) or Mel (N = 148). The incidence of postoperative delirium was significantly lower in the Mel group than in the placebo group (27.0% vs. 39.6%, respectively, P = 0.02). There was no significant difference between 30-day all-cause mortality (12.2% vs. 14.1%, P = 0.62) and drug reactions (0 vs. 2.0%, P = 0.25). The length of stay and hospitalization costs in the Mel group were significantly decreased compared with those in the placebo group (P > 0.05). Conclusion: The current study suggests that Mel is safe and effective in the treatment of delirium after PCI. Further investigation is necessary to fully understand the potential usefulness of Mel in older patients via larger randomized, multicenter, double-blind, and placebo-controlled trials.

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