To compare the effectiveness, toxicities, and cost of two granulocyte colony-stimulating factor (G-CSF) preparations

Patients were randomized to two group—one receiving filgrastim and one receiving lenograstim  after one chemotherapy treatment cycle. Patients then crossed over to the opposite preparation for the next chemotherapy cycle.

• N = 29
• AGE RANGE = 2–16 years
• MALES: 62%, FEMALES: 38%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; most frequent were Ewing sarcoma, osteosarcoma, and neuroblastoma

• SITE: Single site 
• SETTING TYPE: Multiple settings 
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care

• Crossover, randomized, two-group trial

Febrile neutropenia was defined as absolute neutrophil count less than .05x10³ cells per µL and oral or axillary temperature above 38.3 degrees centigrade or 38.0 for more than one hour.

No differences were seen in treatments in febrile neutropenia, antibiotic use, rate of infection, use of platelet transfusions, or hospitalization. Cost was significantly lower with filgrastim (p = .002). No differences were seen between treatments in adverse effects. Bone pain was the most frequent side effect, with no significant differences between treatments

Findings suggest that efficacy and side effects of filgrastim and lenograstim are equivalent. Filgrastim use was less costly.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Other limitations/explanation: Patients had a variety of diseases and were getting a wide variety of chemotherapy treatments given the small sample size, which potentially would impact the risk of febrile neutropenia.

Findings show that both of these G-CSF formulations provide similar results but differ substantially in cost. Nurses can advocate for less costly alternatives for care according to patients’ financial situations. The main side effect for patients is bone pain, which needs to be addressed effectively.

Methylphenidate immediate release was administered at 5 mg twice daily and was titrated to effect as much as 20 or 30 mg per day if no response occurred after three and five days, respectively. Doses were given in the morning and at noon to limit insomnia. Treatment was discontinued after one week if no improvement was reported.

• In total, 11 patients were included.    
• Age ranged from 50 to 79 years.
• Men and women were included.
• Patients had various advanced malignancies.
• Ethnicity was not reported.

• Inpatient and outpatient   
• Large university cancer center

Patients were undergoing the end of life phase of care.

The study used a prospective, case series, open-label design; no comparison group was used.

• No formal fatigue measures were used.
• Patients self-reported improvement in fatigue.

Of the 11 patients, two experienced no improvement in fatigue on methylphenidate and one required 30 mg to sustain improvements in fatigue. Eight patients experienced improvements in their self-reported levels of fatigue after treatment with 10 mg daily in a divided dose.

• The study was open-label, with no randomization or control or comparison group.
• The study was a small case series.
• Six patients experienced a side effect, including insomnia (n = 5), agitation (n = 1), anorexia (n = 1), nausea and vomiting (n = 1), and dry mouth (n = 1).

No special training is required to deliver the intervention. Costs are related to drug acquisition.

To determine if tranexamic acid and cryoprecipitate led to a reduction in blood loss and red cell transfusions in patients with peritoneal malignancies having surgery, and to see if the effect of the change in practice would lead to change in coagulation parameters or incidences of thrombosis

For the group in 2011, the standard protocol for cytoreductive surgery with hyperthermic intraperitoneal peroperative chemotherapy included using fresh frozen plasma (FFP) pre-emptively two hours into surgery, as well as for significant blood loss guided by laboratory values. Red blood cells, platelets, and cryoprecipitate were also transfused per laboratory values, per protocol. Following the CRASH-2 study, in 2013, a new protocol was devised to administer tranexamic acid at the beginning of surgery, with a repeated dose four hours into the procedure. If hemorrhage starts before 2 L of blood loss, cryoprecipitate is given with pre- and post-coagulation laboratory values. Laboratory tests were conducted throughout the surgery with intervention as appropriate.

• N = 201 
• AGE = 55 years
• MALES: 35%, FEMALES: 65%
• CURRENT TREATMENT: Chemotherapy, surgery
• KEY DISEASE CHARACTERISTICS: Peritoneal malignancy treated with cytoreductive surgery combined with hyperthermic intraperitoneal peroperative chemotherapy

• SITE: Single site  
• SETTING TYPE: Inpatient     
• LOCATION: United Kingdom

PHASE OF CARE: Active antitumor treatment

Prospective trial with a matched historical comparison group

• Two-tailed student t test using Excel
• P < 0.05 was significant. 
• The outcomes were measured by evaluating the fibrinogen, hemoglobin, prothrombin time, activated partial thromboplastin time, and platelets before and during the surgery.

The new protocol, using tranexamic acid, led to maintained average fibrinogen levels, a statistically significant increase in hemoglobin levels during and just following surgery, and a statistically significant reduction in blood loss. No significant reduction in FFP was observed and no difference in deep vein thrombosis existed in the two groups.

The patients given tranexamic acid and cryoprecipitate during cytoreductive surgery had higher fibrinogen levels and a decrease in blood loss—higher hemoglobin levels and fewer red cell transfusions. No higher arterial or venous thrombosis were observed in this group compared to the prior group.

• Risk of bias (no control group)            
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Measurement/methods not well described                  
• Measurement validity/reliability questionable
• Findings not generalizable
• Data samples from two different time periods, with changes in practice and issues of data; new protocol gives clearer direction to the team caring for patient 
• Because the newer protocol added tranexamic acid and cryoprecipitate together, it is unclear how they determined which was effective.

Nurses caring for patients with peritoneal cancer undergoing cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy should be aware of tranexamic acid and cryoprecipitate use to reduce blood loss.

APPLICATIONS: Palliative care

Interventions included pain education, culturally sensitive online support and education, and coaching versus controls. Meta-analysis of pooled results from these three studies did not show a significant overall effect on pain intensity. Interventions across studies varied in terms of frequency, duration, and intensity.

This analysis did not demonstrate a significant impact of psychosocial/psychoeducational types of interventions on pain intensity among disadvantaged patient groups. There is insufficient evidence to draw any firm conclusions.

• Few studies were included.
• Generally high risk of bias in included studies

No firm conclusions can be drawn regarding the effectiveness of psychosocial interventions for pain management among disadvantaged patient groups. There is a lack of research in this area. Findings here point to the need to develop and test these types of interventions for potentially vulnerable patient populations.

The purpose of this study was to evaluate the potential effect of carbamazepine for chemotherapy-induced nausea and vomiting (CINV) for moderately or highly emetogenic chemotherapy (MEC or HEC). The secondary aim was to evaluate side effects of this treatment and its influence on quality of life.

The standard antiemetic regimen was given to all patients, which includes ondansetron IV 8 mg, dexamethasone IV 10 mg, and ranitidine IV 50 mg prior to chemotherapy (day 1). All patients also received dexamethasone PO 4 mg BID on days 2 and 3. In addition to the standard of care, all patients received carbamazepine 200 mg PO four times per day on the third day before chemotherapy, BID on the second day before chemotherapy, and three times a day on the day before chemotherapy. Patients continued taking carbamazepine 200 mg PO three times per day until the fifth day after chemotherapy. Patients recorded data on days 1–6. Rescue therapy was given as needed and included 5-HT3RA, phenothiazines, butyrophenones, and domperidone.

• N = 7  
• AGE = 48 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer, highly emetogenic chemotherapy regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score for all 10 women was 0, first cycle of chemotherapy

• SITE: Single-site    
• SETTING TYPE: Outpatient  
• LOCATION: Brazil

• PHASE OF CARE: Active antitumor treatment

Prospective, descriptive study

• Functional Living Index-Emesis (FLIE) questionnaire
• Patients recorded all episodes of vomiting on diary cards starting with chemotherapy and for six days after.  
• Complete response was defined as the absence of any events of vomiting and no use of rescue medications.

Ten patients signed informed consent, three subjects could not complete the study due to adverse events (two had vomiting prior to chemotherapy and one experienced severe somnolence). The remaining seven patients had no response to the treatment, and there was no documented impact on quality of life as measured by the FLIE. The study was therefore discontinued.

The study was closed after seven subjects completed the protocol without any positive response for CINV. Carbamazepine was not found to be effective for CINV in women treated with highly emetogenic chemotherapy and caused vomiting in 20% of patients prior to the induction of chemotherapy.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Subject withdrawals ≥ 10%

Because the study was closed due to a 0% efficacy for CINV in this small sample of women with breast cancer, carbamazepine should not be recommended for CINV treatment at this time.

To evaluate the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with emetogenic therapy in adult patients in India

Enrolled patients were randomized into one of two groups receiving either ramosetron 0.1 mg (group 1) or ondansetron 4 mg (group 2). Tablets were taken in the morning beginning one hour before chemotherapy and continuing for five days. Medications that could influence CINV were not permitted during the trial. Rescue medications were used at the discretion of the investigator. Data were recorded for five days.

• N = 214  
• AGE RANGE = 18–75 years
• MALES: 73 (34%), FEMALES: 141 (65%)
• KEY DISEASE CHARACTERISTICS: Multiple cancers, emetogenic chemotherapy regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Any patient who experienced vomiting 24 hours prior to study was excluded  

• SITE: Multi-site    
• SETTING TYPE: Outpatient  
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment

Prospective, open-label, randomized, experimental design

• 4-point criteria adapted from National Cancer Institute Common Toxicity Criteria (NCICTC)
• Patient report of nausea and vomiting
• Investigator Global Assessment of Efficacy (IGAE) 4-point scale
• Adverse events recorded by investigators 

There was no significant difference in nausea and vomiting on day 1 between groups. After day 1, 64.0% of patients in group 1 achieved a complete response compared to 60.0% in group 2. More patients in group 1 as compared to group 2 achieved a complete response in the overall phase (27.2% [95% CI: 35.4%, 19.0%] versus 7.0% [95% CI: 12%, 2%]; difference 20.2% [95% CI: 29.7%, 10.2%]; P < 0.001) . Patients in group 1 reported less severe nausea than patients in group 2 on days 2 (p = 0.019), 3 (p = 0.020), 4 (p = 0.001), and 5 (p = 0.002). Patients in group 1 reported a less severe grade of vomiting on days 3 (p = 0.014) and 5 (p = 0.035).

Patients receiving ramosetron experienced less severe nausea and vomiting in delayed CINV compared to those receiving ondansetron.

• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: The majority of references used for this paper are old.

CINV continues to be a problematic side effect of chemotherapy. Nurses should frequently assess patients for nausea and vomiting in both the acute and delayed phase after administration of chemotherapy, taking note of the severity of both. The use of ramosetron for CINV in Indian patients is as effective as ondansetron and might be preferred for delayed CINV.

To assess the effects of a spiritual care intervention on the quality of life and spiritual well-being of patients with cancer undergoing surgery

A 90-minute spiritual care intervention based on the MATCH (Mercy, Austerity, Truthfulness, Cleanliness, and Holy Name) guideline involving 30 minutes of counseling, reading, and chanting was delivered to patient/caregiver dyads undergoing surgery for cancer daily while in the hospital. Quality of life and spiritual well-being were measured prior to discharge and at one month, two months, and three months.

• N = 107 
• MEAN AGE =  Patients: 51 years (SD = 13), caregivers: 39 years (SD = 12.7)
• MALES: Caregiver information not described
• FEMALES: Caregiver information not described
• CURRENT TREATMENT: Not applicable; patients undergoing surgery
• KEY DISEASE CHARACTERISTICS: Breast cancer (22%), head and neck cancer (54%), mixed and other cancers (24%)

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: India

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Prospective, single-arm, repeated-measures trial

• Functional Assessment of Cancer Therapy-General (FACT-G)
• Functional Assessment of Chronic Illness Therapy—Spiritual Well-being (FACIT-Sp)

Patients and caregivers demonstrated statistically significant improvements in all domains of quality of life and spiritual well-being at all measurements following the intervention.

A spiritual care intervention delivered in a hospital is feasible and has the potential to improve patient and caregiver quality of life and spiritual well-being. Randomized, controlled studies in this area are needed.

• Risk of bias (no control group)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Low return rate
• Potential for recall bias among both groups surveyed
• No control group
• Caregivers not described
• Little data about the intervention
• Limited data on the specifics of the actual dose or number of days delivered
• Single institution in India
• Unclear how intervention fidelity was maintained
• Unclear if intervention was administered by several people and, if so, how they ensured high interrator reliability

Addressing spiritual concerns may be an important method to positively affect caregiver quality of life and spiritual well-being.

To determine the efficacy of zinc sulfate supplements in reducing oral mucositis in patients with head and neck cancer

Patients were randomized to receive zinc supplementation or placebo during radiation therapy. Patients received 50 mg zinc sulfate daily at meal times in a syrup form or an identical placebo syrup. All patients received visous Xylocaine^® and analgesics as considered necessary. The primary study end point was to evaluate the frequency of development of greater than grade 2 mucositis and pharyngitis.

• N = 139   
• MEAN AGE = 62 years
• MALES: 86.8%, FEMALES: 13.2%
• KEY DISEASE CHARACTERISTICS: 53% had stage 3–4 disease, 85% were smokers, and 76% used alcohol

• SITE: Single site  
• SETTING TYPE: Not specified   
• LOCATION: Thailand

• PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled

• National Cancer Institute Common Toxicity Criteria version 2
• Visual analog scale for pain scoring

There was no difference between groups in proportion with greater than grade 2 mucositis. Seventeen percent in the placebo group and 23% in the zinc sulfate group developed grade 3 mucositis. There were no significant group differences in pain severity.

Zinc sulfate supplementation during radiation therapy for head and neck cancer did not produce any benefit in reducing or relieving symptoms of oral mucositis.

• Measurement/methods not well described
• Other limitations/explanation: Timing of pain rating and data used were not well described.

There was no benefit of zinc supplementation for the prevention and management of oral mucositis in this group of patients.

To examine the efficacy and safety of glutamine to reduce vincristine-induced neuropathy in children and adolescents

Patients expected to receive a cumulative dose of 6 mg/m² over a 30-week period were randomized to receive glutamine or placebo. Participants' families were contacted weekly to answer questions and monitor compliance and monitor adverse effects. Study medications were provided in a powder formulation to be mixed in juice for oral administration. Study measures were obtained at baseline, after 21 days, and on day 42 after a wash-out period. Glutamine was given at a dose of 6 g/m² twice daily up to a maximum dose of 10 g.

• N = 49   
• MEDIAN AGE = 11 years
• AGE RANGE = 4–19 years
• MALES: 48.2%, FEMALES: 51.8%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Hematologic malignancies; acute lymphoblastic leukemia was the most common.
• OTHER KEY SAMPLE CHARACTERISTICS: More than 50% were Hispanic.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: New York

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Double-blind, placebo-controlled, randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Purdue Pegboard test
• Grip strength
• Symbol Digit Modalities Test
• Pedatric quality of life

Seventy-eight percent developed peripheral neuropathy as defined by CTCAE. There was no correlation between CTCAE and other testing results. A higher number of those receiving placebo had increased CTCAE sensory neuropathy scores compared to those on glutamine (p = 0.02) on day 21. There was no difference between groups on day 42. There were no differences between groups in motor neuropathy scores.

Glutamine had a protective effect for sensory neuropathy in this study. Varied measures for peripheral neuropathy were not correlated, pointing to the need for ongoing research to identify the most valid and reliable measures for assessment.

• Small sample (< 100)
• Baseline sample/group differences of import
• The glutamine group had lower sensory neuropathy scores at baseline.

There have been mixed findings regarding the benefits of glutamine for the prevention of chemotherapy-induced peripheral neuropathy. This study demonstrated some benefit, although limited by sample size. Ongoing research is needed for determination of any potential role of glutamine for the prevention of neuropathy with agents associated with this side effect.

To determine the effect of changing needleless connectors (NC) frequently on central line–associated bloodstream infections (CLABSI) rates

The study was conducted among pediatric bone marrow transplantation (BMT) recipients and the oncology unit population, and was conducted and evaluated in three interrupted times. In time period 1, the healthcare professionals changed needleless connectors (NC) every 96 hours regardless of the infusion of blood products, lipids/total parenteral nutrition (TPN), and IV amphotericin B. In period 2, they changed NC every 24 hours only with blood products and lipids/TPN. In period 3, they changed the NC every 96 hours regardless of infusate. Moreover, they collected data on central venous catheter (CVC) bundle access, which involves hand hygiene and cleaning connectors with alcohol for 15 seconds. In a different general oncology unit, healthcare workers change connectors every 24 hours across all study periods. 

• N = None given, 44 CLABSI episodes    
• AGE = Pediatric, no age specified
• MALES: Not specified, FEMALES: Not specified
• KEY DISEASE CHARACTERISTICS: Stem cell transplantation recipients and patients with cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Blood product transfusion, lipids transfusion, and infusion of IV liposomal amphotericin B

• SITE: Multi-site    
• SETTING TYPE: Inpatient    
• LOCATION: Boston, MA

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Pediatrics

• Retrospective cohort time series analysis

• Center for Disease Control (CDC) and the National Healthcare Safety Network (NHSN) guidelines for central venous catheter (CVC) care 
• CLABSI rate was number of infections per 1,000 central-line days
• CLABSI defined per National Healthcare Safety Network definitions

According to CDC and NHSN guidelines, NC should be changed every 24 hours, but this study suggests that frequent NC changes may increase the rate of CLABSI.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Sample size was not described appropriately.
• Method of data collection and measurement for unit adherence to catheter care bundle guidelines was not described.

Nurses should follow CVC access bundle (i.e., hand hygiene, cleaning the NC with alcohol for 15 seconds) while handling CVCs. In addition, organizational policies may help decrease CLABSI and other infections among BMT recipients and patients with cancer as they are at a very high risk of acquiring bloodstream infections. The appropriate frequency of changing all IV line components is unclear. Additional research is needed to establish the evidence base for some infection prevention guidelines.