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1.
J Nurses Prof Dev ; 39(5): E119-E124, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37683214

RESUMEN

The COVID-19 pandemic has required healthcare organizations to creatively address patient care needs. The pandemic-induced disruption resulted in multiple examples of disruptive innovation. Several innovative strategies and learnings identified during the COVID-19 pandemic have resulted in approaches to nursing education and staffing, which will serve to optimize the future healthcare environment. The solutions identified by the nursing workforce during the COVID-19 pandemic can readily be replicated in similar or dissimilar healthcare environments.


Asunto(s)
COVID-19 , Personal de Enfermería , Humanos , Pandemias , Aprendizaje , Recursos Humanos
2.
Cancer ; 118(20): 5171-8, 2012 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-22415454

RESUMEN

BACKGROUND: Paclitaxel causes an acute pain syndrome (P-APS), occurring within days after each dose and usually abating within days. Paclitaxel also causes a more classic peripheral neuropathy, which steadily increases in severity with increasing paclitaxel total doses. Little detail is available regarding the natural history of these 2 syndromes, or any relationship between them, although a recent publication does provide natural history data about weekly paclitaxel, supporting an association between the severity of P-APS and eventual peripheral neuropathy symptoms. METHODS: Patients entering this study were about to receive paclitaxel and carboplatin every 3 weeks. Daily questionnaires were completed for the first week after every chemotherapy dose, and European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy 20-item instruments were completed weekly. RESULTS: The P-APS severity peaked on day 4 after the initial chemotherapy dose, with 12%, 29%, 23%, and 36% of patients having maximal pain scores of 0, 1 to 4, 5 or 6, or 7 to 10 during the first week after the first dose of therapy, respectively. Patients with P-APS scores of 0 to 4 with the first dose of chemotherapy had less eventual sensory neuropathy than did patients with P-APS scores of 5 to 10 (P = 0.001). With regard to the more peripheral neuropathy, sensory neuropathy was more problematic than was either motor or autonomic neuropathy. Numbness and tingling were more common components of the sensory neuropathy than was pain. CONCLUSIONS: Patients with worse P-APS severities appear to have more eventual chemotherapy-induced peripheral neuropathy. This provides support for the concept that P-APS is a form of nerve pathology.


Asunto(s)
Dolor Agudo/inducido químicamente , Antineoplásicos Fitogénicos/efectos adversos , Paclitaxel/efectos adversos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Dolor Agudo/etiología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Síndrome
3.
Support Care Cancer ; 20(3): 625-32, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21479990

RESUMEN

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by numbness, tingling, and shooting/burning pain. This analysis was performed to describe the relationship between numbness, tingling, and shooting/burning pain in patients with CIPN, as reported using the EORTC QLQ-CIPN20 (CIPN20). METHODS: Baseline CIPN20 data were provided for all patients on a prospective trial designed to treat patients with bothersome CIPN. Baseline frequencies for the items on the CIPN20 are primarily described by descriptive statistics and histograms, with correlational analyses between individual items. RESULTS: A majority of the 199 patients accrued to this study reported "quite a bit" to "very much" numbness (57%) or tingling (63%) in the hands compared to "a little" or "not at all" (numbness (43%), tingling (38%)). Fewer patients reported "quite a bit" to "very much" shooting/burning pain in the hands (18%). Numbness and tingling in the hands were highly correlated (r = 0.69), while neither were highly correlated with shooting/burning pain. Similar results were observed in the feet. More severe ratings for tingling and shooting/burning pain were ascribed to the lower extremities, as opposed to the upper extremities. CONCLUSIONS: In patients with CIPN, severe sensory neuropathy symptoms (numbness, tingling) commonly exist without severe neuropathic pain symptoms (shooting/burning pain), while the reverse is not common. Symptoms in the feet should be evaluated distinctly from those in the hands as the experience of symptoms is not identical, for individual patients, in upper versus lower extremities.


Asunto(s)
Examen Neurológico/instrumentación , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/diagnóstico , Encuestas y Cuestionarios , Femenino , Humanos , Hipoestesia/inducido químicamente , Hipoestesia/diagnóstico , Masculino , Persona de Mediana Edad , Dolor/inducido químicamente , Dolor/diagnóstico , Parestesia/inducido químicamente , Parestesia/diagnóstico , Estudios Prospectivos , Trastornos de la Sensación/inducido químicamente , Trastornos de la Sensación/diagnóstico , Índice de Severidad de la Enfermedad
4.
Support Care Cancer ; 19(7): 941-7, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-20496155

RESUMEN

PURPOSE: Hot flashes are a significant problem in breast cancer patients, especially because the most effective therapy, estrogen, is often contraindicated. Based on recent pilot data from a single group supporting the use of a stellate ganglion block for the treatment of hot flashes, the present pilot trial was done to further evaluate the hypothesis that a stellate ganglion block may be a safe and effective therapy for hot flashes. METHODS: In women with breast cancer who had hot flashes, a stellate ganglion block was performed after 1 week of baseline hot flash data collection. The main efficacy measures were the changes from baseline in hot flash frequency and hot flash score during the 6th week. RESULTS: Ten patients were enrolled between 4/23/2009 and 7/10/2009; eight patients were evaluable. After the stellate ganglion block, the mean hot flash frequency and score decreased from baseline values by over 60% during some of the post-treatment weeks. The mean hot flash frequency and score at week 6 decreased from baseline values by 44% and 45%, respectively. There were no significant adverse events clearly attributed to the stellate ganglion blocks. CONCLUSIONS: The results of this pilot trial support that stellate ganglion blocks may be a helpful therapy for hot flashes. A prospective placebo-controlled clinical trial should be done to more definitively determine this contention.


Asunto(s)
Anestésicos Locales/uso terapéutico , Bloqueo Nervioso Autónomo/métodos , Neoplasias de la Mama/patología , Bupivacaína/uso terapéutico , Sofocos/tratamiento farmacológico , Ganglio Estrellado/efectos de los fármacos , Adulto , Anciano , Anestésicos Locales/administración & dosificación , Bloqueo Nervioso Autónomo/instrumentación , Bupivacaína/administración & dosificación , Femenino , Humanos , Persona de Mediana Edad , Proyectos Piloto , Encuestas y Cuestionarios
5.
Lancet Oncol ; 9(10): 993-1001, 2008 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19071256

RESUMEN

Women with breast cancer have many adverse symptoms, of which some are specific to premenopausal patients. Management of these common symptoms include non-hormonal drugs, such as antidepressants and antiseizure compounds to alleviate hot flushes. Non-oestrogenic vaginal lubricants seem to moderately decrease occurrence of vaginal dryness and dyspareunia. Transdermal testosterone alone has not been shown to improve libido in these women. Options for fertility preservation include cryopreservation of embryos or oocytes before chemotherapy. Exercise is the one evidenced-based intervention shown to positively affect cancer-related fatigue. However, effective prevention and treatments for peripheral neuropathy and paclitaxel acute pain syndrome remain elusive. Weight-bearing exercise helps to maintain bone strength with adequate intake of calcium and vitamin D. Use of bisphosphonates in women taking aromatase inhibitors (combined with ovarian suppression in premenopausal women) to prevent bone fractures has not been substantiated, although it should be considered in women with osteoporosis. No specific drug has been shown to prevent radiation-induced dermatitis alone. Although some effective treatments can counteract symptoms related to cancer or treatments, research is needed to expand evidence-based care in premenopausal survivors of breast cancer.


Asunto(s)
Antineoplásicos/efectos adversos , Conservadores de la Densidad Ósea/uso terapéutico , Neoplasias de la Mama/terapia , Fertilidad , Sofocos/terapia , Premenopausia , Antidepresivos/uso terapéutico , Trastornos del Conocimiento/inducido químicamente , Trastornos del Conocimiento/terapia , Dermatitis/etiología , Dermatitis/terapia , Femenino , Sofocos/inducido químicamente , Sofocos/tratamiento farmacológico , Humanos , Libido/efectos de los fármacos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Radioterapia/efectos adversos
6.
Eur J Cancer ; 44(11): 1507-15, 2008 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-18571399

RESUMEN

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose limiting side effect of many commonly used chemotherapeutic agents, including platinum drugs, taxanes, epothilones and vinca alkaloids, and also newer agents such as bortezomib and lenolidamide. Symptom control studies have been conducted looking at ways to prevent or alleviate established CIPN. This manuscript provides a review of studies directed at both of these areas. New evidence strongly suggests that intravenous calcium and magnesium therapy can attenuate the development of oxaliplatin-induced CIPN, without reducing treatment response. Accumulating data suggest that vitamin E may also attenuate the development of CIPN, but more data regarding its efficacy and safety should be obtained prior to its general use in patients. Other agents that look promising in preliminary studies, but need substantiation, include glutamine, glutathione, N-acetylcysteine, oxcarbazepine, and xaliproden. Effective treatment of established CIPN, however, has yet to be found. Lastly, paclitaxel causes a unique acute pain syndrome which has been hypothesised to be caused by neurologic injury. No drugs, to date, have been proven to prevent this toxicity.


Asunto(s)
Antineoplásicos/efectos adversos , Calcio/administración & dosificación , Magnesio/administración & dosificación , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Acetilcarnitina/uso terapéutico , Acetilcisteína/uso terapéutico , Anticonvulsivantes/uso terapéutico , Antidepresivos Tricíclicos/uso terapéutico , Baclofeno/uso terapéutico , Glutamina/uso terapéutico , Humanos , Infusiones Intravenosas , Ketamina/uso terapéutico , Naftalenos/uso terapéutico , Nootrópicos/uso terapéutico , Paclitaxel/uso terapéutico , Enfermedades del Sistema Nervioso Periférico/prevención & control , Piridinas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Vitamina E/uso terapéutico
7.
Menopause ; 24(7): 774-782, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28266949

RESUMEN

OBJECTIVE: The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction. METHODS: Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes. RESULTS: The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study. CONCLUSIONS: Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Sofocos/terapia , Hipnosis/métodos , Clorhidrato de Venlafaxina/uso terapéutico , Ciencias Bioconductuales , Terapia Combinada , Método Doble Ciego , Femenino , Sofocos/psicología , Humanos , Persona de Mediana Edad , Proyectos Piloto , Resultado del Tratamiento
8.
Clin Nurse Spec ; 31(6): 343-348, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28991018

RESUMEN

PURPOSE: The purpose of this project was to standardize vital sign (VS) monitoring throughout a patient's stay in the hospital, including at admission, following transitions to different levels of care, reassessment of abnormal VS results, daily monitoring, and before dismissal. The population of focus was adult general and progressive care patients. DESCRIPTION OF THE PROJECT: Standards for VS monitoring, documentation, and provider notification were established. Unit routines, nursing procedural guidelines, and order sets were updated with the new standards. Nursing staff received Web-based education. Compliance with the new standards was monitored monthly, and data were shared with nursing leadership. Leadership reviewed the data with nursing staff to identify opportunities and recognize achievements. OUTCOMES: Overall, improvement in VS documentation was achieved. Continued opportunities exist for monitoring and reassessment of a full set of VSs after an abnormal result. CONCLUSION: Establishing a minimum standard of VS frequency and documentation allows for all healthcare providers to trend and monitor a patient's clinical status. Variability in patient care can be diminished by establishing minimum standards of VS monitoring.


Asunto(s)
Monitoreo Fisiológico/enfermería , Monitoreo Fisiológico/normas , Enfermeras Clínicas/organización & administración , Mejoramiento de la Calidad/organización & administración , Signos Vitales , Documentación/estadística & datos numéricos , Hospitalización , Humanos , Investigación en Evaluación de Enfermería
9.
Clin Nurse Spec ; 20(2): 75-80, 2006.
Artículo en Inglés | MEDLINE | ID: mdl-16609281

RESUMEN

UNLABELLED: Without formal education, many healthcare professionals fail to develop interdisciplinary team skills; however, when students are socialized to interdisciplinary practice through academic clinical learning experiences, effective collaboration skills can be developed. Increasingly, educational environments are challenged to include clinical experiences for students that teach and model interdisciplinary collaboration. PURPOSE: The purpose of this quality improvement initiative was to create an interdisciplinary educational experience for clinical nurse specialist (CNS) students and postgraduate physicians. DESCRIPTION OF THE PROJECT: The interdisciplinary learning experience, supported by an educational grant, provided an interdisciplinary cohort of learners an opportunity to engage in a clinically focused learning experience. The interdisciplinary cohort consisted of CNS students and physicians in various stages of postgraduate training. The clinical experience selected was a quality improvement initiative in which the students were introduced to the concepts and tools of quality improvement. During this 1-month clinical experience, students applied the new skills by implementing a quality improvement project focusing on medication reconciliation in the outpatient setting. The CNS core competencies and outcomes were used to shape the experience for the CNS students. OUTCOME: The CNS students exhibited 5 of the 7 essential characteristics of the CNS (leadership, collaboration, consultation skills, ethical conduct, and professional attributes) while demonstrating competencies and fulfilling performance expectations. During this learning experience, the CNS students focused on competencies and outcomes in the organizational sphere of influence. Multiple facilitating factors and barriers were identified. CONCLUSION: This interdisciplinary clinical experience in a quality improvement initiative provided valuable opportunities for CNS students to develop essential CNS characteristics and to explore practice competencies in the area of systems. IMPLICATIONS: Interdisciplinary clinical experiences offer students opportunities to develop needed collaboration and communication skills. Educators should create interdisciplinary educational experiences for students to better prepare them for their roles in a clinical setting.


Asunto(s)
Educación de Postgrado en Medicina/organización & administración , Educación de Postgrado en Enfermería/organización & administración , Enfermeras Clínicas/educación , Grupo de Atención al Paciente/organización & administración , Competencia Profesional , Atención Ambulatoria/organización & administración , Actitud del Personal de Salud , Conducta Cooperativa , Curriculum , Quimioterapia/enfermería , Quimioterapia/normas , Objetivos , Humanos , Relaciones Interprofesionales , Liderazgo , Modelos Educacionales , Enfermeras Clínicas/psicología , Rol de la Enfermera , Investigación en Educación de Enfermería , Evaluación de Procesos y Resultados en Atención de Salud/organización & administración , Competencia Profesional/normas , Evaluación de Programas y Proyectos de Salud , Socialización , Análisis de Sistemas , Gestión de la Calidad Total/organización & administración
10.
12.
Menopause ; 20(11): 1164-8, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23571528

RESUMEN

OBJECTIVE: This study aims to examine the accuracy of a new sternal skin conductance (SSC) device in measuring hot flashes and to assess the acceptability of the device by women. METHODS: Three small descriptive pilot studies were performed using two sequential prototypes of the SSC device developed by an engineering device company in the Midwest. The devices were worn either in a monitored setting for 24 hours or in an ambulatory setting for 5 weeks. During the study period, women recorded hot flashes in a prospective hot flash diary and answered questions about the acceptability of wearing the SSC device. RESULTS: The first prototype was not able to collect any analyzable skin conductance data owing to various malfunction issues, including poor conductance and battery failure. However, 16 women wore the device for 5 weeks and reported that wearing the device was acceptable, although 31% stated that it interfered with daily activities. Hot flash data from the second prototype revealed a 24% concordance rate between self-reported and device-recorded hot flashes. CONCLUSIONS: Findings from these studies support discordance between device-recorded and self-reported hot flashes. In addition, the studies reveal further limitations of SSC monitoring, including difficulties with data collection and lack of consistency in interpretation. Based on these results and other recent trials identifying issues with SSC methodology, it is time to find a better physiologic surrogate measure for hot flashes.


Asunto(s)
Respuesta Galvánica de la Piel/fisiología , Sofocos/diagnóstico , Menopausia , Monitoreo Ambulatorio/instrumentación , Monitoreo Fisiológico/instrumentación , Esternón , Femenino , Historia Antigua , Humanos , Persona de Mediana Edad , Monitoreo Ambulatorio/métodos , Monitoreo Fisiológico/métodos , Proyectos Piloto , Estudios Prospectivos , Autoinforme , Piel/irrigación sanguínea , Temperatura Cutánea , Salud de la Mujer
13.
Menopause ; 20(2): 179-84, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-22990758

RESUMEN

OBJECTIVE: Paced breathing (slow, deep, diaphragmatic breathing) reduces central sympathetic activity and facilitates the relaxation response. The present study was designed to assess the feasibility of and to obtain initial efficacy estimates of two paced-breathing programs, compared with usual breathing, for the frequency and severity of hot flashes. METHODS: We designed a 9-week, randomized, three-arm, parallel-group, blinded (investigator) phase II clinical trial. Using an audio CD, participants in the active arms practiced paced breathing at 6 breaths/minute for 15 minutes, either once or twice a day, whereas the control arm practiced usual breathing at 14 breaths/minute for 10 minutes/day. Feasibility was assessed through self-report questionnaires; percent reduction and effect size estimates were determined using changes in hot flash frequency and scores within each group. RESULTS: Of the 92 eligible participants, 68 (74%) completed the study. Most women reported that the intervention was easy to do (79%) and of appropriate duration (71%). They could practice exercises as taught (61%) and could practice on most days (65%). Participants in all arms reported hot flash reductions during the 9 weeks: 52% for paced breathing twice a day, 42% for paced breathing once a day, and 46% for usual breathing. CONCLUSIONS: The paced-breathing intervention is feasible. Although paced breathing twice a day seems to be the most helpful dose, efforts to intensify paced breathing once a day may be more practical for widespread dissemination. The efficacy and overall clinical impact of paced-breathing exercises on hot flash reduction require further evaluation in an adequately powered, placebo-controlled, randomized phase III clinical trial.


Asunto(s)
Sofocos/terapia , Frecuencia Respiratoria/fisiología , Adolescente , Adulto , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Humanos , Menopausia Prematura , Persona de Mediana Edad , Relajación Muscular , Placebos , Encuestas y Cuestionarios , Resultado del Tratamiento
14.
J Palliat Med ; 14(7): 810-4, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21554125

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect. Previous studies have primarily focused on prophylactic therapy, but no published reports have evaluated the treatment of breakthrough CINV. METHODS: A prospective, pilot study was performed to provide preliminary prospective evidence of the efficacy of individual agents prescribed for the treatment of breakthrough CINV. Enrolled patients were receiving moderately or highly emetogenic chemotherapy and prophylactic treatment of CINV based on antiemetic guidelines. Patients were prescribed an antiemetic for breakthrough CINV at the discretion of their treating oncologist. If patients had breakthrough CINV that required a breakthrough antiemetic medication, they were instructed to complete a questionnaire every 30 minutes for 4 hours after taking the antiemetic. Levels of nausea (0-10), vomiting, and side effects were recorded. RESULTS: Of the 96 patients enrolled, 27 (28%) reported breakthrough nausea and/or vomiting requiring medication and completed the questionniare. Eighty-eight percent (n = 24) reported the use of prochlorperazine; they experienced a 75% median nausea reduction after 4 hours, with minimal side effects. Three patients (12%) reported the use of a 5-hydroxytryptophan (5-HT) receptor antagonist for treatment of breakthrough nausea. These patients reported a median nausea reduction of 75% after 4 hours and no perceived toxicities. CONCLUSIONS: Prochlorperazine and 5-HT receptor antagonists appear to be effective breakthrough antiemetic therapies. The described study methodology can be used to conduct randomized clinical trials to find more effective drugs for treating established nausea.


Asunto(s)
Antieméticos/uso terapéutico , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Adulto , Atención Ambulatoria , Antieméticos/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del Tratamiento
15.
J Clin Oncol ; 29(11): 1472-8, 2011 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-21383290

RESUMEN

PURPOSE: The characteristics and natural history of the paclitaxel-acute pain syndrome (P-APS) and paclitaxel's more chronic neuropathy have not been well delineated. METHODS: Patients receiving weekly paclitaxel (70 to 90 mg/m(2)) completed daily questionnaires and weekly European Organisation for Research and Treatment of Cancer (EORTC) Chemotherapy-Induced Peripheral Neuropathy (CIPN) -20 instruments during the entire course of therapy. RESULTS: P-APS symptoms peaked 3 days after chemotherapy. Twenty percent of patients had pain scores of 5 to 10 of 10 with the first dose of paclitaxel. Sensory neuropathy symptoms were more prominent than were motor or autonomic neuropathy symptoms. Of the sensory neuropathy symptoms, numbness and tingling were more prominent than was shooting or burning pain. Patients with higher P-APS pain scores with the first dose of paclitaxel appeared to have more chronic neuropathy. CONCLUSION: These data support that the P-APS is related to nerve pathology as opposed to being arthralgias and/or myalgias. Numbness and tingling are more prominent chronic neuropathic symptoms than is shooting or burning pain.


Asunto(s)
Antineoplásicos Fitogénicos/efectos adversos , Paclitaxel/efectos adversos , Dolor/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedad Aguda , Área Bajo la Curva , Distribución de Chi-Cuadrado , Femenino , Humanos , Persona de Mediana Edad , Dimensión del Dolor , Estudios Prospectivos , Estadísticas no Paramétricas , Encuestas y Cuestionarios , Síndrome
16.
J Clin Oncol ; 28(35): 5182-7, 2010 Dec 10.
Artículo en Inglés | MEDLINE | ID: mdl-21060036

RESUMEN

PURPOSE: Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid-based topical keratolytic agent (ULABTKA) may prevent HFS. PATIENTS AND METHODS: A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m(2) per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. RESULTS: The percentage of patients with moderate/severe HFS symptoms was not different between groups, being 13.6% in the ULABTKA arm and 10.2% in the placebo arm (P = .768 by Fisher's exact test). The odds ratio was 1.37 (95% CI, 0.37 to 5.76). Cycle 1 CTCAE skin toxicity was higher in the ULABTKA arm but not significantly so (33% v 27%; P = .82). No significant differences were observed in other toxicities between groups. CONCLUSION: These data do not support the efficacy of a ULABTKA cream for preventing HFS symptoms in patients receiving capecitabine.


Asunto(s)
Dermatosis del Pie/prevención & control , Dermatosis de la Mano/prevención & control , Queratolíticos/uso terapéutico , Ácido Láctico/uso terapéutico , Urea/uso terapéutico , Administración Tópica , Antimetabolitos Antineoplásicos/efectos adversos , Capecitabina , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Método Doble Ciego , Combinación de Medicamentos , Femenino , Fluorouracilo/efectos adversos , Fluorouracilo/análogos & derivados , Dermatosis del Pie/inducido químicamente , Dermatosis de la Mano/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Síndrome
17.
Menopause ; 16(1): 184-7, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-18725865

RESUMEN

OBJECTIVE: Newer antidepressants have been shown in clinical trials to reduce hot flashes, although not as well as do hormones. Nonetheless, a recently published meta-analysis and subsequent editorial raised doubts with regard to the utility of newer antidepressants for treating hot flashes. Concerns about the lack of efficacy of newer antidepressants on hot flashes were based in large part on results of two placebo-controlled, double-blind trials, one evaluating venlafaxine and the other individually evaluating both fluoxetine and citalopram. These two studies have repeatedly been put forward as evidence that newer antidepressants are not definitively proven to reduce hot flashes. DESIGN: Raw data from these two randomized, placebo-controlled trials evaluating second-generation antidepressants for hot flashes were obtained. These data and subsequent study conclusions are evaluated and discussed in the context of other published trial data regarding the use of newer antidepressants for treating hot flashes. RESULTS: Examination of the raw data from these two trials revealed that neither employed a baseline period of hot flash determination against which to calculate changes over time from baseline. CONCLUSIONS: Recognition that these two trials cannot be used to look at hot flash frequency or score changes from baseline limits their ability to inform the efficacy literature about the use of newer antidepressants for hot flash reduction.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Sofocos/tratamiento farmacológico , Citalopram/uso terapéutico , Ciclohexanoles/uso terapéutico , Método Doble Ciego , Femenino , Fluoxetina/uso terapéutico , Humanos , Placebos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Clorhidrato de Venlafaxina
18.
Cancer J ; 13(6): 399-403, 2007.
Artículo en Inglés | MEDLINE | ID: mdl-18032978

RESUMEN

PURPOSE: Paclitaxel therapy often result in a unique subacute pain syndrome, commonly termed "myalgia" or "arthralgia." The pathophysiology of this syndrome is unknown and has not been demonstrated to be associated with any structural alteration of muscles or joints. We hypothesized that this syndrome was caused by a neuropathic nerve injury from paclitaxel. Herein, we characterize the clinical characteristics of this syndrome using detailed patient interviews and consider the putative mechanism(s) for these symptoms. METHODS: Oncology patients who were treated with paclitaxel and developed a subacute pain syndrome were questioned using a detailed structured interview. Data were tabulated descriptively. RESULTS: Eighteen patients were interviewed. The symptoms (ie, pain) typically began 1-2 days after the infusion and lasted for a median of 4-5 days. Pain was most commonly located in the back, hips, shoulders, thighs, legs, and feet, with the most common descriptors used being "aching" or "deep pain." Commonly used adjectives to describe the pain were radiating, shooting, aching, stabbing, and pulsating. Some patients described increased pain with weight bearing, walking, or tactile contact. When asked directly whether the pains appeared to be specifically localized to either joints or muscles, 15 of 18 patients denied localization. DISCUSSION: Based on the nature and temporal occurrence of the paclitaxel acute pain syndrome symptoms, we infer that the paclitaxel acute pain syndrome occurs as a result of sensitization of nociceptors, their fibers, or the spinothalamic system. This proposed neurologic etiology of this pain may also explain the subsequent development in some patients of a symmetric length-dependent sensorimotor polyneuropathy. The mechanism of this syndrome needs further study.


Asunto(s)
Antineoplásicos Fitogénicos/efectos adversos , Neoplasias/complicaciones , Nociceptores/efectos de los fármacos , Paclitaxel/efectos adversos , Dolor/etiología , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Nociceptores/fisiología , Dolor/fisiopatología , Manejo del Dolor
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