Drug Topics - February 11, 2008 - (Page HSE16) 16 HSE DRUG TOPICS FEBRUARY 11, 2008 www.drugtopics.com Clinical Practice Anti-leukemia drug increases fatigue in pediatric patients Julio Fernandez, Pharm.D. examethasone has demonstrated that it’s highly effective in the treatment of pediatric acute lymphoblastic leukemia (ALL). However, it is associated with certain worrisome side effects including disrupted sleep and fatigue. “Dexamethasone is more powerful than the other glucocorticoids for the treatment of ALL,” said Pamela S. Hinds, Ph.D., RN, FAAN, director for the Division of Nursing Research at the St. Jude Children’s Research Hospital in Memphis, Tenn. Acute lymphoblastic leukemia is the most common cancer diagnosed in children and represents 23% of cancer diagnoses among children younger than 15 years. “Treatment for children with ALL, which usually ranges between two and three years, is divided into stages, which includes remission induction, consolidation or intensification, and continuation therapy,” stated Jennifer L. Pauley, Pharm.D., clinical pharmacist at St. Jude Children’s Research Hospital. Continuation therapy is the maintenance phase of treatment that includes treatment with dexamethasone as well as other chemotherapeutic agents. D ing the first five days, patients did not receive dexamethasone (off-dex) and during the second consecutive five days they received dexamethasone (on-dex). Patients in the low-risk St. Jude’s group received dexamethasone 8mg/m2 per day divided into three doses for five days, while the St. Jude’s standard-risk group received 12mg/m2 per day. The low-risk and standardrisk COG groups received dexamethasone 6mg/m2 per day divided into two doses for seven days. Patients wore an actigraph on the wrist 24 hours a day for 10 days. Parents and patients who were seven years of age and older completed fatigue instruments on days two to five of each treatment period. Patient and parent fatigue reports indicated that dexamethasone is associated with significantly increased fatigue. The St. Jude standard-risk group, which received the highest dexamethasone dose, had the fewest actual sleep minutes, sleep duration, and sleep efficiency than the other risk groups. “We have recently opened our next protocol for the treatment of pediatric ALL and the treatment in that protocol includes a lower dose of dexamethasone in the continuation phase. Dexamethasone dose will be 6 mg/m2 for both the low-risk and standard-risk groups,” stated Hinds. Pharmacists’ role Pharmacists play an important role in monitoring dexamethasone dosing, drug interactions, and adverse events, such as fluid retention, mood disorders, fatigue, and altered sleep, offered Pauley. The frequency of adverse events in pediatric patients with ALL related to sleep and fatigue caused by dexamethasone is unknown. Recently, St. Jude Children’s Research Hospital in collaboration with Texas Children’s Cancer Center and Sick Children’s Hospital of Toronto conducted a 10-day study in 100 patients ages five to 18 years old during continuation treatment for ALL The goal was to determine the relationship between dexamethasone and sleep quality and fatigue levels. In addition, researchers tested if patient demographics such as age, sex, and ALL risk category influenced the extent of change in sleep and fatigue observed during dexamethasone treatment. Patients were divided into four subgroups: St. Jude’s low risk, St. Jude’s standard risk, Children’s Oncology Group (COG) low risk, and COG standard risk. Dur- Degree of disturbance The degree of sleep disturbance and fatigue was influenced by age and sex. Boys experienced more nocturnal awakenings per night. Additionally, adolescents had lower sleep duration and total sleep minutes compared with children during the on-dex period. The findings of the study indicate that before the initiation of therapy, healthcare providers should discuss with parents and patients the potential side effects of dexamethasone and how to possibly minimize them. “We can prepare parents and let them know that their children are going to have disturbed sleep and increased fatigue. We can also educate parents and children with regard to proper sleep hygiene, one part of which is making sure that the children are on a sleep schedule, going to sleep at the same time, and attempting to get up around the same time,” noted Hinds. “If we have the potential to identify patients who will be the most sensitive to dexamethasone, this will allow us to design optimal dosing schedules for individual patients,” concluded Hinds. THE AUTHOR is a writer based in New Jersey. Photo: Jim Shive http://www.drugtopics.com
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