To evaluate the efficacy of benzydamine oral rinse for prevention of radiation-induced mucositis

Patients rinsed for 2 minutes four times a day with 15 mL study medication (0.15% benzydamine oral rinse) or identical placebo (in appearance and taste) from the first day of radiation therapy (RT) to the end of treatment. Patients were encouraged to brush their teeth at least twice daily and rinse as necessary with normal saline or sodium bicarbonate. Commercial mouthwashes were prohibited.

• The study reported on a sample of 81 patients with a mean age 56.
• There were 54 females and 27 males.
• All patients had been diagnosed with head and neck cancer and were scheduled to receive a total external beam RT dose of at least 50 Gy in standard fractions and at least 2 oral or oropharyngeal sites were included in the planned RT treatment volume.

The study was conducted at the Radiation Oncology Department of the Cancer Institute at Tehran University of Medical Sciences in 2004-2005.

This was a double-blind, randomized, placebo-controlled trial.

• Patients oral hygiene before and during RT (number of tooth brushing per day) was recorded.
• The Radiation Therapy Oncology Group (RTOG) grading system was used.
• Patients were visited once.

• The statistical analysis revealed that three variables significantly affected the grade of mucositis at the end of the treatment: smoking before and during RT (p = 0.008), chemoradiation (p = 0.002), and receiving benzydamine (p = 0.001).
• Benzydamine produced a statistically significant reduction in mucositis during RT (p < 0.001).
• An increase in the grade of mucositis in the first three weeks of treatment was found in both groups, but, after that time, a remarkable difference was found in this parameter in the two groups. Overall, mucositis scores increased rapidly in severity between the third and seventh week of treatment, with a plateau occurring near the end of RT in the placebo group. In the benzydamine group, the plateau appeared from the third week to the end of therapy.

Benzydamine 0.15% oral rinse was safe and well tolerated. It significantly reduced RT-induced mucositis, which also decreased the interruption of treatment.

• The study was conducted at a single institution.
• The sample size was small, with fewer than 100 patients.
• The authors did not address who conducted the mucositis assessment, opening up the possibility for discrepancy between the evaluators.

Nurses will need to know how to effectively teach patients to use the oral rinse. This study also highlights the importance of daily oral hygiene, which is another good teaching point.

To assess the preventive effects of single and repeat treatment with dexamethasone on delayed nausea and vomiting in patients receiving carboplatin-based chemotherapy

• The study was carried out using the Ehime University Hospital electronic health record.
• It consisted of 64 patients with various malignancies who had been treated with carboplatin-based combination chemotherapy. 
• Chemotherapy-induced nausea and vomiting (CINV) assessment was conducted three times a day for the first five days after the chemotherapy cycle began, using the nausea and emesis score and food intake score.  
• The frequency of need for rescue antiemetics also was assessed.

• The study consisted of 64 patients.
• The mean age was 59 years for the Repeat Treatment group and 62 years for the Single Treatment group. 
• Race was not included in the sample description.
• Just over half of the patients were male (57%).
• Patients were diagnosed primarily with lung and ovarian cancers.
• Patients were excluded if they had complications such as brain metastases that might induce nausea or vomiting, hepatic failure, or ulcerative diseases; were receiving drugs that affect nausea and vomiting (e.g., major or minor tranquilizers, corticosteroids given for other reasons than prevention of CINV); were receiving concomitant radiation therapy; or were receiving total parenteral nutrition (TPN).

This was a single-site study conducted at an inpatient setting in Ehime, Japan.

• All patients were in active treatment.
• The study has applications for late effects and survivorship.

This was a retrospective, observational study.

• Nausea and emesis was rated on a five-point scale (1 = absent,  3 = nausea, 5 = emesis).
• Food intake was rated on a five-point scale (5 = complete intake, 3 = partial meal, 1 = missed meal because of nausea and vomiting).
• Frequency of need for rescue antiemetics was recorded.

• Demographic data was very different for the two groups. The Repeat Treatment Group was comprised of all women with gynecologic cancers. The Single Treatment group was mostly lung cancer, and 71% of the group were male. Data from both groups demonstrated that nausea and vomiting was well controlled on Day 1. The Single Treatment group received almost all placlitaxel, while the Repeat Treatment Group received docetaxel. No patients in the Single Treatment group experienced emesis, and only two subjects experienced emesis in the Repeat Treatment group.
• A significant negative correlation was found between the total nausea and vomiting scores and food intake scores on days 2–5.
• Almost half of the patients (45%) required antiemetics. The frequency of need for rescue antiemetics overall was significantly less in the Repeat Treatment group (26.9%) compared to the Single Treatment group (57.9%).
• Overall response was 0.268 (CI = 0.091–0.789, p = 0.015).

• The authors stated that repeat treatment of dexamethasone may be more effective than single-dose dexamethasone for prevention of delayed CINV (after 24 hours) for patients treated with carboplatin-based combination chemotherapy.
• The Repeat Treatment Group, which consisted of all women treated with multiple doses of dexamethasone, experienced less delayed CINV, as defined by the need for rescue antiemetics.
• Results would need to be confirmed in a larger, prospective clinical trial.

• This retrospective study design relied on the accurate documentation of events by others.
• This study had a small sample size of 64 subjects, with even smaller groups for comparison study.
• The groups were not heterogenous, making comparison difficult. The only constant was the use of carboplatin-based combination chemotherapy.
• All patients were not chemotherapy naïve. History of previous CINV, smoking history, or motion sickness was not described.
• Measurement scales combining nausea and vomiting are not precise enough to know magnitude of nausea.

Patients treated with carboplatin-based combination chemotherapy may benefit from a daily dose of dexamethasone for three days following initiation of chemotherapy.

To evaluate the effectiveness of implementing the new methicillin-resistant Staphylococcus aureus (MRSA) control measures in a tertiary care unit in Japan

The study was conducted in Japan, where the rate of MRSA was the second highest in the Asia-Pacific region—69.5%—in 2002. Although Japan was following infection control practices, the rate was not going down because its survey for the incidence of MRSA was not standardized. In 2003, according to the Society for Healthcare Epidemiology of America (SHEA), Japan started to strictly follow the evidence-based infection control guidelines, which included wearing gowns, masks, and gloves, in addition to implementing contact isolation in a separate room and conducting nasal swab cultures for colonization before discontinuing isolation. Two basic metrics also have been included to conduct surveys on the basis of SHEA and the Infection Control Practices Advisory Committee. To conduct this study, the authors have reviewed patients' data from January 2003–December 2010.

• N = 1,000
• AGE: No specific age noted
• MALES, FEMALES: Not noted
• KEY DISEASE CHARACTERISTICS: MRSA

• SITE: Single site           
• SETTING TYPE: Inpatient           
• LOCATION: Tertiary care center in Japan

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

• Quasi-experimental cohort study conducted to evaluate the changes of MRSA incidence and MRSA bloodstream infection (BSI) incidence after implementation of the infection control practices in the tertiary care center

•  SAS (version 9.2)

The study showed a significant reduction in MRSA infection or colonization and MRSA BSI (p < .0001) after strongly implementing the new infection control practices in the tertiary setting.

This was the first study conducted at a tertiary level in Japan. It was based on the evidence based-practice showing a significant reduction in MRSA spread and MRSA infection burden, which was proved after strictly following the new practices of MRSA control, including isolating the patient. Through this study, the authors also standardized in discontinuing the isolation of MRSA patients based on SHEA and the Infection Control Practices Advisory Committee.

• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: This study implemented multifaceted interventions, and defining the relative effect of each intervention is impossible. The test used is only able to detect the outcomes and cannot detect changes in trends.

Nurses play an important role in implementing infection control practices, as nurses are the one who come into contact with patients first. Nurses can follow these guidelines and also advise other healthcare workers to do the same.

The objective of this study was to evaluate the efficacy of injectable form of oxycodone on pain and dyspnea in terminally ill patients with cancer.

• Medical records of patients who received continuous subcutaneous oxycodone for pain relief were analyzed. 
• Patients' verbal ratings that were documented were used for analysis. 
• Changes in ratings and use of rescue doses were analyzed.

• The study reported on a sample of 95 patients.
• The mean age was 71.7 years, with a range of 47–92 years.
• Of the sample, 56% were males and 44% were females.
• Tumor types varied; the most common were lung and colon.
• All patients were in inpatient hospice care.

This single-site study was conducted in an inpatient setting in Japan.

• Patients were receiving end-of-life care.
• The study has clinical applicability for palliative care.

The study was a retrospective, descriptive trial.

A three-point symptom severity verbal rating was used.

• The most frequent reason for initiating subcutaneous oxycodone was patient difficulty taking oral medication. 
• Duration of administration ranged from 2.08–111.2 days, with an average of 14.4 days. 
• Initial base dosages used ranged from 4.8–84.6 mg per day, and final base doses averaged 61.8 mg per day, with a range of 3.8–192 mg per day. 
• Most patients were previously receiving parenteral morphine, oral oxycodone, or transdermal fentanyl.
• Effect on pain was rated as moderate in 50% of patients and as high in 41.7%.
• Effect on dyspnea was moderate in 36.5% and high in 4.2%. 
• The most common side effect was drowsiness/somnolence.

Subcutaneous oxycodone administration was effective for reduction of pain and dyspnea in some patients.

• The study had a small sample size of less than 100 patients.
• The study had a risk of bias (no control group, no blinding, and no random assignment).
• Measurement validity/reliability is questionable.
• Data were extracted retrospectively from medical records.

• This study describes the experience of one group in using subcutaneous oxycodone in end-of-life palliative care. 
• The study has many limitations, so the strength of this evidence is low. 
• Subcutaneous oxycodone administration may be a useful alternative for pain and dyspnea management in some patients.

To study the effects of low-level laser therapy (LLLT) in postmastectomy lymphedema

Patients were randomly assigned to either a laser or sham group. Patients in the laser group were treated with GA-As laser device wavelength 890 nm over the arm and axillary areas. Therapy was administered three times a week for three weeks. Then, after an eight-week interval, the same treatment protocol was repeated. Patients received a total of 18 treatments.

• The study involved 11 female patients; eight patients completed the therapy (four in each group).
• The patients were all diagnosed with unilateral postmastectomy lymphedema.

This was a double blind controlled trial.

Investigators measured changes in patients’ limb circumferences, pain scores, range of motion (ROM), heaviness of the affected limb, and desire to continue the treatment. Measurements were taken before and during the treatment at 3, 9, 12, 18, and 22 weeks.

• Eight patients completed the study.
• Reduction in limb circumference occurred in both groups but was greatest in the treatment group.
• Greater pain reduction occurred in the treatment group and desire to continue the therapy was greater in the treatment group. The other two parameters had no difference.

The study reported that LLLT may be effective in reducing arm circumference and pain. Researchers encouraged further studies with larger samples and more therapy. The study used a good design and excellent blinding.

• The study size was very small.
• The design had some similarities to Carati et al. (2003) but did not use same means of objective assessment.

STUDY PURPOSE: To complete a systematic review of palliative care interventions in randomized, controlled trials (RCTs) involving adults with life-limiting illness and meta-analysis to identify the relationship of those intervention with quality of life, symptom burden, and survival of those adults and their caregivers

TYPE OF STUDY: Systematic review of palliative care RCTs

• FINAL NUMBER STUDIES INCLUDED = 56 (30 with cancer)
• TOTAL PATIENTS INCLUDED IN REVIEW = 12,731 patients, 2,479 caregivers 
• SAMPLE RANGE ACROSS STUDIES: The mean patient age was 67 years; no caregiver age data were available. Sample sizes ranged from 27–434 participants.
• KEY SAMPLE CHARACTERISTICS: All patients had life-limiting illnesses. Patients were in hospital, home, and ambulatory settings. Subjective outcomes: Half of reviewed trials had a high level of bias (55.8%), and 16% had a low level of bias; the rest was unknown. Objective outcomes: 44% had a high level of bias, and 6.9% had a low level of bias; the rest was unknown or not measured. Study interventions included physical and psychological aspects of care, with cultural sensitivity underused and underrepresented. Interventions addressed a median of five of eight palliative care components.

PHASE OF CARE: Active cancer care
 
APPLICATIONS: Palliative care

The reviewers looked at nine domains: patient quality of life, physical symptoms, survival, patient mood, advanced care planning, site of death, resource utilization and expenditures, satisfaction with care, and caregiver outcomes resulting from patient symptom burden, survival, and quality of life. Patient quality of life was assessed in 24 studies (4,576 patients). Twelve of those studies had high risk of bias and seven were low risk of bias (five were unknown). Of the seven low-risk-of-bias studies, five reported improved quality of life. In fifteen trials, quality of care was associated with a statistically significant improvement in quality of life. High bias and heterogeneity were significant issues in the analysis. Physical symptoms were reviewed in 29 trials (10,105 people). Seventeen of 29 trials looked at physical symptoms. Of the seven that were low risk bias, after sensitivity analyses, palliative care was not associated with change in symptom burden in four trials at the 1- to 3-month follow-up because of heterogeneity. The reviewers went on to describe that, because of high risk of bias and heterogeneity, no association existed between palliative care and improved survival, patient mood, advanced care planning, site of death, and resource use.

In this review, the evidence suggests that palliative care intervention improves symptom burden and patient quality of life in those who have been diagnosed with an advanced cancer or with a serious illness. The review was not able to establish if palliative care improved caregiver quality of life. Significant issues existed with assessing the association of palliative care with quality of life, symptom burden, and adult survival because of the problematic quality and rigor of RCTs used in the systematic review and meta-analysis.

• Mostly low quality/high risk of bias studies
• High heterogeneity
• The authors reported multiple limitations of this review, including the wide spectrum and diversity in palliative care interventions. This diversity contributed to heterogeneity to the meta-analysis. Missing data, the exclusion of quasiexperimental studies, and trial statistical analysis may have contributed to underpowered studies in the meta-analysis. Across trials, clinical trial data were not uniformly reported, and information about points in time when patient and caregiver may have received palliative care was lacking. The risk of study bias (a subjective interpretation) and use of the Cochrane Risk of Bias tool may not have defined specifics of behavioral interventions found in many of the trial studies used in the meta-analysis and systematic review.
• No specific information provided on evaluation rating forms
• No caregiver-only studies included in meta-analysis to measure caregiver outcomes
• No trial focused on influence of culture on intervention assessment or effect.

Multiple RCTs have established that palliative care improves patient experience and quality of care. Insufficient evidence exists to assess whether that is true for patient and caregiver dyads or for caregivers assessed separately from patients. More studies reflecting methodological rigor, cultural sensitivity, and quality to identify aspects of effective palliative care for both patients and caregivers remain a priority.

The purpose of the study was to determine if amitriptyline would be effective in treating chemotherapy-induced peripheral neuropathy (CIPN) compared to placebo.

Patients were allocated to amitriptyline or placebo groups. Treatment was started at 25 mg per day, and doses were elevated 25 mg per week up to a maximum dose of 100 mg per day if tolerated. Treatment was continued until the end of the neurotoxic chemotherapy. Follow-up visits were performed every two months and patients were asked to maintain a diary in which they graded neutopathic symptoms by a visual analog scale twice a week. The primary end point was the appearance or progression of neuropathic symptoms based on diary data.

• A total of 99 participants were recruited for this study, with women outnumbering men 72% to 28%, respectively.
• The mean age of study participants was 56 years with a range of 25–75 years.
• The most common diagnoses amongst the participants were ovarian cancer, lymphoma, and colorectal cancers.
• Other key characteristics include receiving vinca alkaloids, platinum-based taxanes, or a combination of these agents.
• Forty-seven percent of the participants were in first-line chemotherapy; 44% were receiving adjuvant chemotherapy.

The study was conducted in an outpatient, single-site setting in Helsinki, Finland.

The study was designed as a double blind, randomized, placebo-controlled parallel group.

Measurements include the National Cancer Institute's Common Terminology Criteria for Adverse Events, the European Organisation for the Research and Treatment of Cancer C30 quality-of-life measure, and a visual analog scale for symptom grading.

The median follow-up was at 19–21 weeks. Seventy-four percent of patients were on the highest dose of amtriptyline, which was well tolerated. Tiredness was the most frequent reason for dose reduction. In addition, no differences were noted in intensity of neuropathy between groups. In the majority of cases, the intensity of neuropathy was mild at grade 1. Neuropathy was seen in 76% of patients after nine cycles of treatment. Because of a lack of effect, the study was discontinued earlier than planned.

The study did not demonstrate any effect by amitriptyline on the prevention or treatment of CIPN.

• Small sample size (less than 100 participants).
• The study was underpowered.
• The study ended early because of a lack of effectiveness in the study design.

The findings from this study do not support the use of amitriptyline for the prevention and management of CIPN.

To compare the antiemetic effectiveness of palonosetron plus dexamethasone (PD) versus ondansetron plus dexamethasone (OD) for patients with head and neck cancer receiving moderately emetogenic chemotherapy (MEC)

Patients with head and neck cancer who were receiving a standardized MEC regimen (60 mg/m² IV docetaxel, 300 mg/m² IV carboplatin, and 600 mg/m² IV 5-flurouracil) were randomly assigned to one of two groups. During the first cycle of chemotherapy, group one received palonosetron plus dexamethasone (PD) as antiemetic prophylaxis therapy and group two received ondansetron plus dexamethasone (OD) as antiemetic prophylaxis therapy. For the second cycle, the groups crossed over and group one received OD as antiemetic prophylaxis therapy and group two received PD as antiemetic prophylaxis therapy. The efficacy of the antiemetic prophylaxis medication combinations was evaluated at each of the two cycles of chemotherapy by recording the intensity of nausea and the frequency of vomiting. These outcome variables were evaluated during three phases of treatment: the acute phase beginning at chemotherapy administration and ending 24 hours after, the delayed phase beginning 24 hours after chemotherapy administration and ending five days after, and overall for the five days following chemotherapy administration.

• The sample consisted of 30 patients who had been diagnosed with head and neck cancer receiving MEC (60 mg/m² IV docetaxel, 300 mg/m² IV carboplatin, and 600 mg/m² IV 5-FU).
• Patients' ages ranged from 25–60 years.
• Mean age and gender of patients was not reported.

The study was conducted at a single outpatient site at a large medical center in India.
 

All patients were in active treatment.

The study used a randomized, crossover design.

Patients recorded each instance of emesis over the five-day, post-chemotherapy period and the intensity of their nausea using a four-point, descriptive ordinal scale ranging from no nausea to severe nausea.

No significant differences were found between groups for any of the study outcomes (emesis frequency and nausea intensity) in any of the treatment phases (acute phase, delayed phase, and overall).

No difference was found in antiemetogenic efficacy between the PD and OD groups.

The study sample was small with fewer than 100 patients.

As a second-generation 5-HT₃ antagonist, palonosetron, may be more effective in preventing and reducing chemotherapy-induced nausea. Some studies have demonstrated that palonosetron is more effective at reducing chemotherapy-induced nausea and vomiting (CINV), while other studies, such as this one, have not. More research must be done before any formulary changes can be proposed.

To compare the efficacy of triplet versus doublet antiemetic therapy in patients receiving mitoxantrone, etoposide, and cytarabine (MEC) chemotherapy

Patients were randomized to receive either palonosetron, dexamethasone, and aprepitant, or ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) control.

• N = 60
• MEAN AGE = 51 years
• AGE RANGE = 34–70 years
• MALES: 86.6%, FEMALES: 13.4%
• KEY DISEASE CHARACTERISTICS: All patients had head and neck cancer.

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

• PHASE OF CARE: Active antitumor treatment

• Open-label, randomized, prospective trial

• Count of emesis episodes
• Nausea measured on 100 mm visual analog scale (VAS)

Complete response (CR), defined as no vomiting and no rescue medications, was seen in 86.7% of those on triplet therapy and 60% of those on doublet therapy in the acute phase (p < 0.05). In the delayed phase, the CR was 83.3% and 53.3% of those on triplet and doublet therapy respectively (p < 0.05). The authors cited the WHO cost effective and strategic planning guidelines to note that because triplet therapy was more effective, it was cost-effective.

The findings showed that triplet therapy was associated with higher CR rates for CINV prevention than doublet therapy (without an NK1) for patients receiving MEC.

• Small sample (< 100)
• Risk of bias (no blinding)

A growing volume of research exists to compare antiemetic regimens with and without NK1s, likely because of the cost of NK1 medication. This study showed that triplet therapy containing NK1 was effective for the control of CINV in a greater proportion of patients than doublet therapy. CINV is a debilitation side effect of chemotherapy. Nurses can advocate for the use of the interventions that are most effective for symptom control among patients receiving MEC and HEC.

To evaluate the efficacy of endoscopic ultrasound-guided (EUS) celiac plexus block (CPB) and celiac plexus neurolysis (CPN) in alleviating chronic abdominal pain due to chronic pancreatitis (CP) or pancreatic cancer

• Databases searched were MEDLINE, PubMed, and EMBASE. Date range searched was January 1966–December 2007.
• Search keywords were endoscopic ultrasound, EUS, celiac plexus block, celiac plexus neurolysis, chronic pancreatitis, pancreatic cancer, and CP.
• Studies were included if
  • The reports were published in English.
  • Patients were at least 18 years old and had unremitting chronic abdominal pain due to CP or unresectable pancreatic cancer.
  • Patients needed narcotic analgesics for pain control.
  • The studies had enrolled at least 10 patients who had undergone EUS CPB or CPN.
• Authors did not cite exclusion criteria.

The initial search retrieved 588 articles. Authors selected nine studies for analysis (six of CP pain, three of pain due to pancreatic cancer). The report provides no data regarding quality rating. Of the six studies of CP, three were full articles and three were abstracts. Of the three studies of pancreatic cancer, one was an abstract. Across most studies, methods and procedures were similar. Because current expert consensus precludes the use of absolute alcohol in CPN of patients with CP, due to the potential for inducing fibrosis and limiting future surgical options, authors excluded from the meta-analysis partial data from one study. In this study investigators had used bupivacaine and alcohol in 5 of 19 patients.

• The sample was composed of 340 patients.
• Authors did not report sample range.
• Of all patients, 221 patients had CP and 119 had pancreatic cancer.

EUS CPB for CP was associated with a reduction of abdominal pain in 51% of patients but not with consistent elimination of the need for narcotic analgesics. However, in one study 47% of patients withdrew from narcotics. EUS CPB in CP patients offered temporary relief, up to 48 weeks, in some studies, but short-term pain relief may not indicate long-term effect. EUS CPN for pancreatic cancer pain was associated with a 73% reduction in pain. However, two of three studies reported that narcotic use did not change significantly post-CPN. Analysis of the patients with pancreatic cancer pain showed that the location of the tumor and the timing of EUS CPN were significant factors in the efficacy of the treatment and in pain and narcotics use.

• The number of studies analyzed was small. This could have had some effect on heterogeneity and publication bias.
• Authors did not provide details regarding pain etiology applicable to studies of CPB in CP.
• The studies did not track changes in quality of life.
• Physiologic evaluation for narcotic addiction was not part of the exclusion criteria in any of the studies. Addiction could have contributed to the lack of response in the CPB subgroup.
• Presentation of meta-analysis results is unclear.

Evidence suggests that EUS CPB is somewhat effective in managing the pain of appropriately selected patients. The evidence is not strong, however, and most effects appear to be temporary. EUS CPB is not an effective single method of pain control; EUS CPB may be useful only as a method of achieving temporary relief from acute flares.