To compare the efficacy and safety of neurolytic celiac plexus blockade (NCPB) to the efficacy and safety of standard treatment of patients with unresectable pancreatic cancer

• Databases searched were Ovid, PubMed, MEDLINE, EMBASE, HealthSTAR, and the Cochrane Library. In addition, investigators performed manual searches of revelant materials. The date range searched was 1966–2005.
• Search keywords were celiac block, celiac plexus block, celiac plexus neurolysis, and splanchnicectomy.
• Studies were included if they
  • Were randomized controlled trials that compared NCPB to standard treatment.
  • Involved patients with pancreatic cancer.
• Studies were excluded if they involved NCPB as a treatment for conditions other than pancreatic cancer.

The search retrieved 491 articles. Authors described the data-abstraction procedures, quality-rating method, and meta-analysis procedures.

The sample included five randomized controlled trials whose results were published 1993–2004. The sample was composed of 302 patients.

• Effect of NCPB on pain as measured by a visual analog scale:
  • Weighted mean difference (WMD) at two weeks was not significantly different between control group and NCPB group.
  • At four weeks, NCPB showed a benefit, with WMD –0.50, 95% CI –0.85 through –0.15, p = 0.005.
  • At eight weeks with NCPB, WMD was –0.60, 95% CI 0.82 through –0.37, p < 0.00001.
• Effect of NCPB on opioid use:
  • At week 2, NCPB was associated with significantly lower opioid use (WMD –39.99 mg, 95% CI –60.08 through –19.91, p < 0.0001).
  • The difference in opioid intake increased over time, with the maximum reported difference at week 8: WMD –80.45 mg, 95% CI –134.66 through –26.24, p = 0.0004).
• Survival and quality of life (QoL): Authors observed no survival benefit with NCPB.  Two studies provided information about QoL. QoL decreased in a general pattern of decline in both treatment and control groups, with no significant difference between groups
• Adverse effects: In the NCPB group, constipation decreased significantly (RR 0.67, p = 0.01). The NCPB group showed a trend toward hypotension, but the trend was not statistically significant.

Compared with standard treatment, NCPB was associated with significant improvement in pain. Although the average change in pain score was small, the change was accompanied by a significant reduction in opioid use for pain control. The durability of NCPB impact is unknown. Effect seems to increase within eight weeks, but no data are available regarding use beyond that period. The study demonstrated no significant intergroup differences in the relative risk of adverse events.

Nurses should be aware that NCPB is an option for managing the pain of patients with unresectable pancreatic cancer. Awareness will enable nurses to advocate for the procedure when appropriate and to inform patients of potential treatment options. The duration of NCPB is unknown.

To test the effectiveness of royal jelly on the prevention of mucositis in patients with head and neck cancer receiving chemotherapy and radiation

The royal jelly (RJ) was collected from the species Apis mellifera with a primary diet of nectar and pollen from flowers in China. Patients in the intervention group applied 1 g of royal jelly three times per day for the duration of radiation treatment (RT), and patients in the control group did not apply royal jelly. Data were collected during radiation twice per week and one month after radiation was complete.

• N = 13  
• AGE RANGE = 51–84 years
• MALES: 92.3%, FEMALES: 7.6%
• KEY DISEASE CHARACTERISTICS: Hypopharyngeal, oropharyngeal, laryngeal, oral cavity squamous cell carcinoma
• OTHER KEY SAMPLE CHARACTERISTICS: Three different chemotherapy regimens; radiation therapy dose 33–35 fractions (60–70 Gy)

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: Kyorin University School of Medicine, Tokyo, Japan

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

Randomized, single-blinded (physician-blinded) trial

• Inspection 
• Fiberscope 
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3 used to grade mucositis

In the control group, 100% (six) patients experienced grade 3 oral mucositis at the end of radiation compared to the 71.4% (five) who experienced grade 3 in the RJ group and the 28.6% (two) who experienced grade 2 mucositis in the RJ group. RJ delayed the progression to grade 2 mucositis (19 ± 4.1 days in the RJ group, 25.9 ± 9.6 days in the control group, p < .001). RJ also significantly delayed the progression to grade 3 mucositis (37.4 ± 11.8 days in the RJ group, 31 ± 5.8 days in the control group, p < .001).

The results of this study suggest that the topical application of RJ is effective in preventing accelerated mucositis induced by chemoradiotherapy.

• Small sample (< 30)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: Different chemotherapy regimens; no description of regimens; RT dose may have differed based on the disease site

Chemoradiotherapy for head and neck cancer continues to cause significant mucositis, which is debilitating and can impact nutritional status, comfort, and often patients' ability to complete therapy without treatment breaks. The topical administration of RJ offers one intervention that could improve this side effect; however, further studies are needed to support these findings.

To investigate the efficacy of a traditional Japanese medicine, hangeshashinto (TJ-14), in the prevention of chemoradiation-induced oral mucositis

Records were reviewed retrospectively. All patients underwent fractioned radiation with or without concurrent chemotherapy. Researchers compared data from 40 patients who were treated with TJ-14 to those of 40 patients who underwent radiotherapy or concurrent chemoradiotherapy treatment during the study period and did not receive TJ-14 (the control group). Those who received TJ-14 rinsed and gargled with 2.5 g of the intervention drug dissolved in 100 mL of oral rinse solution. Patients rinsed and gargled with the solution three times per day for 30 seconds after meals and during and after chemoradiation treatment and then swallowed or expectorated the solution. No food or drink was allowed for 30 minutes after treatment. Both groups brushed and gargled with six drops of 4% sodium gualenate hydrate and tap water as well as lidocaine gargle, NSAIDs, and opioids as needed.

• N = 80  
• AVERAGE AGE = 68 years
• MALES: 95%, FEMALES: 5% 
• KEY SAMPLE CHARACTERISTICS: Patients who underwent whole-neck radiation of > 60 Gy with or without chemotherapy

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

• PHASE OF CARE: Active treatment

Retrospective chart review comparing those who used the study medication and those who did not.

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 for oral mucositis

A mulivariate analysis indicated that the use of TJ-14 (p = .019), a patient's gender (p = .024), and a patient's primary tumor location (p = .028) were significant factors associated with the severity of oral mucositis. TJ-14 was associated with a significantly improved rate of completion of chemoradiation with cisplatin (p = .002). However, the study purpose was to prove the effectiveness in preventing oral mucositis. No primary endpoint was ever mentioned.

Additional studies to determine effectiveness are needed. Future studies should be more specific as to the type of chemotherapy used and how by whom oral assessments are completed. The authors of this study were trying to measure too many variables within one small study. Study purpose was too general.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no random assignment)
• Key sample group differences that could influence results 
• Measurement/methods not well described 
• Measurement validity/reliability questionable 
• Findings not generalizable
• Other limitations/explanation: No way to validate whether the oral assessments were reliable, valid, or reproducible. The measurement method was questionable. The written report was confusing and contained too many study variables.

This retrospective record review provides a platform on which well-designed, randomized, controlled studies can be based to evaluate the effectiveness of TJ-14 for the prevention of oral mucositis. Well-designed studies are needed to prove the effectiveness of this medication.

To determine the effectiveness of efferent lymphatic vessel anastomosis on subclinical lower extremity lymphedema and on the prevention of lower extremity lymphedema in patients with gynecologic cancer

Fourteen patients with unilateral lower extremity subclinical lymphedema received the intervention of supermicrosurgical efferent lymphatic vesssel-to-vessel anastomosis under local anesthesia. Leg dermal backflow (LDB) was used to determine preoperative and postoperative lymphedema volume. Patients were re-evaluated at a one-year interval.

• N = 14  
• AGE RANGE = 34–79 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All gynecologic cancers including ovarian, uterine, and cervical
• OTHER KEY SAMPLE CHARACTERISTICS: No inguinal lymph node dissection; five had a history of pelvic radiation; six had a history of cellulitis 

• SITE: Not stated
• SETTING TYPE: Outpatient    
• LOCATION: Toranomon Hospital and University of Tokyo in Japan

• PHASE OF CARE: Late effects and survivorship

Pre- and post-test design

• Lower Extremity Lymphedema (LEL) Index 
• Leg Dermal Backflow (LDB) Staging
• Student paired T test and two tests for statistic analyses

All 14 of the surgeries were without perioperative issues. Tension sensation in patients was decreased (significant finding), and a downstaging of LDB stage also was significant.

This study was an important start for investigating improved surgical techniques to reduce and prevent the burden of lower extremity lymphedema. However, the sample size was too small, and other possible variables (such as history of certain chemotherapies or current treatments) were not discussed. It also was unclear how the participants were chosen or if they were randomized properly.

• Small sample (< 30)
• Risk of bias (no random assignment) 
• Other limitations/explanation: Unclear whether patients continued to receive chemotherapy; body surface area unknown

For nurses, having knowledge of these interventions is important to understanding how to educate patients on current and future options. Being up to date on current interventions and knowing if one's facility is current is important to each nurse's individual practice and professional growth. However, this is not an intervention that nurses can directly affect at this point.

To evaluate the effectivness of 1% chlorhexidine-gluconate ethanol (CHG-EtOH) versus 10% povidone-iodine among patients with hematologic malignancies and central line catheters

• N = 94 patients (107 CVCs)
• MEAN AGE = 54.9 years (range = 17–86 years)
• MALES: 42%, FEMALES: 58%
• KEY DISEASE CHARACTERISTICS: Malignant lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, and multiple myeloma
• OTHER KEY SAMPLE CHARACTERISTICS: Sites of CVCs were jugular, subclavian, and inguinal

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

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial 

• Exit site infections and ​central line-associated bloodstream infections (CLABSIs) were measured as defined by the Centers for Disease Control and Prevention.

CVC exit site colonization rates were 11.9% with chlorhexidine and 29.2% with povidone-iodine (p = 0.03). CLABSI rates were 3.4% with chlorhexidine and 14.6% with povidone-iodine (p = 0.08). The incidence per catheter days was higher in the povidone iodine group (RR = 0.23, p = 0.041).

This study suggests that the use of 1% CHG-EtOH while preparing patients for the insertion of a central line and while dealing with central lines on a daily basis decreases the CLABSI rate as compared to the use of 10% povidone-iodine. This affects the length of a patient's stay in the hospital and delays the discharge process.

• Small sample (< 100)
• Risk of bias(sample characteristics)
• Other limitations/explanation: About 30% of patients had CVCs in the inguinal area, which is known to be associated with higher infection rates, and the percent of patients with inguinal catheters was higher in the povidone-iodine group. There was high attrition in the povidone-iodine group.

Nurses always are on the front line giving care to patients, and it is their responsibility to prevent the transmission of infection and provide quality care. One of the most certain ways of giving an infection to a patient is through a central line. These findings suggest that the use of 1% CHG-EtOH while manipulating central lines helps decrease the chance of CVC site contamination and may be more effective than povidone-iodine. However, study limitations reduce the strength of this particular finding. Additional studies of the most effective methods for skin preparation would be helpful.

PURPOSE: To summarize the recommendations and rationale for the pharmacologic management of cancer pain and identify the best practices in cancer pain management

TYPES OF PATIENTS ADDRESSED: Patients with cancer pain

RESOURCE TYPE: Consensus-based guideline  

PROCESS OF DEVELOPMENT: Task force established with 56 physicians, 25 pharmacists, 23 nurses, one epidemiologist, and seven other professionals; conducted systematic review; drafted recommendations using Delphi methods; developed recommendations based on GRADE system

DATABASES USED: PubMed, PaPaS, Cochrane, review of references in relevant guidelines, textbook review, review of JPSM and Palliative Medicine from January 2000–July 2008  

INCLUSION CRITERIA: Studies that evaluated drugs available in Japan

• PHASE OF CARE: Multiple phases of care 
• APPLICATIONS: Pediatrics, elder care, palliative care 

Sixty-five recommendations were created—24 for general cancer pain management, 24 for managing specific etiologic pain syndromes, 15 for managing opioid-induced adverse effects, and 2 for patient education.

Management of cancer pain includes assessment and an individualized approach to treating mild, moderate-to-severe, severe, and breakthrough pain. Opioids are the mainstay of treatment. Immediate-release (IR) or parenteral opioids should be used for unstable pain, whereas extended-release (ER) and IR opioids can be used for stable pain. Neuropathic pain should be managed with adjuvants (e.g., anticonvulsants, antidepressants, antiarrhythmics, ketamines, corticosteroids), metastatic bone pain with bisphosphonates, epigastric pain with celiac plexus block (pancreatic cancer), thoracic pain with nerve blocks, perineal pain with saddle block or superior hypogastric plexus block, malignant psoas syndrome with muscle relaxants or nerve block, and malignant bowel obstruction with octreotide, scopolamine, or corticosteroids. Adverse events of opioids should be judiciously treated: 1) nausea and vomiting with anti-dopaminergics, prokinetics, and antihistamines; opioid rotation, change of route, 2) constipation with laxatives; consider rotation to fentanyl, 3) drowsiness with psycho-stimulants; opioid rotation, route rotation. Patient education should be employed for all patients.

Only medications available in Japan are included. The focus is on pharmacologic interventions, but some psycho-educational aspects are included.

Patient education is an important part of pain management. In addition, nurses can recommend pharmacologic and procedural strategies to help manage pain in specific patient populations.

RESOURCE TYPE: Evidence-based guideline, as well as expert consensus

No information was provided on the volume of evidence. The grading system developed by the Medical Information Network Distribution Service (MINDS) was used to evaluate the level of evidence, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the strengths of the recommendations.

• Oxygen therapy is recommended in patients with hypoxemia and not recommended in patients without hypoxemia.
• Noninvasive positive pressure ventilation (NPPV) suggested to be used in patients with hypoxemia and hypercapnia
• High-flow nasal cannula oxygen therapy suggested in patients with hypoxemia refractory to standard oxygen therapy

• Systemic morphine is recommended.
• Systemic codeine/dihydrocodeine is recommended.
• Nebulized morphine is not recommended.
• Systemic fentanyl is not recommended.

• Benzodiazepines are not recommended to be used alone.
• Benzodiazepines are recommended to be used in combination with opioids.

• Nebulized furosemide is not recommended.

• Caution against routine use of systemic corticosteroids without the consideration of the cause of dyspnea
• Corticosteroids recommended for patients with lymphangitis carcinomatosa, superior vena cava syndrome, or major airway obstruction

The authors declared that, because of the lack of rigorous evidence, most recommendations statements were based on level of evidence and mostly on expert consensus. Some evidence reviewed were not wholly based on patients with cancer. The authors were unable to find adequate information on treatment effect on quality of life and pharmaco-economic outcomes.

The low level of evidence on which these recommendations are based point to a need for stronger studies on the management of dyspnea in patients with cancer. More research is also needed to investigate the effect of recommended interventions for dyspnea on patient quality of life, as well as cost-effectiveness.

To determine the effectiveness of an oral management program in reducing oral mucositis (OM) incidence and severity in patients undergoing stem cell transplant (SCT)

Patients undergoing hematopoietic SCT were retrospectively enrolled in a study to determine if the occurrence and severity of OM was significantly different between a group of patients who received appropriate oral management and those who did not. The control group underwent SCT in 2007–2008, and the oral management group in 2009. This study included an oral evaluation, from the same oral health professionals, for all 48 enrollees prior to SCT. All serious dental issues (e.g., periodontitis, tooth extraction) were treated prior to starting SCT. Patients in the oral management group received oral care instruction with the transplant team prior to SCT. They also received an additional oral exam from the dentist and hygienist as well as instructions (including tooth brushing and oral swab use), based on their OM status. Both groups were treated with the same medications, based on the same OM toxicity scale, as graded by trained SCT nurses. OM in both groups was treated with azulene sodium sulfate and 4% lidocaine rinse.

• The study reported on 48 patients with cancer.
• The age range of the sample was 16–66 years.
• The sample was 48% male and 52% female.
• Cancer diagnoses included malignant lymphoma, acute myelogenous leukemia, acute lymphocytic leukemia, myleodysplastic syndrome, and multiple myeloma.
• Most of the patients had received allogeneic transplant (n = 35). 
• Significantly more patients in the OM group received allogeneic HCT.
• Ifosfamide, carboplatin, and etoposide (ICE) and fludarabine + melphalan/total body irradiation (TBI) conditioning regimens were significantly different between the oral management and control groups.  

This was a single-site inpatient study conducted at the Tsukuba University Hospital in Tsukuba, Japan.

Patients were undergoing the active antitumor treatment phase of care.

This was an observational, two-group trial.

OM was graded using the National Cancer Institute's (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE, version 3.0).

• The incidence of any grade OM was significantly lower in the oral management group (p < 0.05).
• The median of the most severe OM score was 2 for the control group and 1 for the oral management group. This difference was statistically significant (p < 0.05).
• No significant difference was found between the groups in the duration of oral pain; however, the oral management group showed a tendency toward a shorter duration of pain (p < 0.1).
• All patients with sepsis, in both groups, recovered with antibiotics. No significant difference was found in the incidence of sepsis or in the amount of pain medication required.

Oral management was associated with lower incidence of OM and lower average severity of mucositis in patients undergoing HCT.

• The sample size was small with fewer than 100 patients.
• Important differences existed at baseline between groups, including the prevalence of allogeneic HCT. Key differences could have influenced results.
• A risk of bias exists because of the lack of a control group, blinding, and random assigment, as well as the sample characteristics.
• The study is further limited by the specific treatment group tested and the fact that it was a retroactive study .
• The investigators did not describe specific ongoing oral self care and if this differed between groups. Additionally, patient adherence to daily oral care was not evaluated.

With this study’s evidence, nurses can educate patients and reinforce continued oral care at home as well as recommend dental evaluation prior to starting chemotherapy for patients with oral health issues. These measures should help to reduce oral side effects and reassure patients that they have some control over disease management.

To investigate the effects of oral minocycline and topical steroid along with skin moisturizer on the incidence of skin effects in patients receiving panitumumab

Data were obtained from a retrospective chart review to compare the outcomes of patients who received prophylactic versus reactive oral minocycline. Patients received either 100 mg minocycline daily preemptively or as treatment for skin disorders. Topical steroid could be administered at any time based on physician discretion. All patients were to perform skin care by using a moisturizer.

• N = 38
• MEAN AGE = 62.5 years
• AGE RANGE = 35–87 years
• MALES: 65%, FEMALES: 35%
• KEY DISEASE CHARACTERISTICS: Patients with colorectal cancer. Most in the reactive treatment group were receiving panitumumab alone, and most in the prophylactic group were receiving panitumumab and FOLFOX6.

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

PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison

• Common Terminology Criteria for Adverse Events (CTCAE), version 3

The incidence of grade 2 or higher acneiform rash was 44% in the prophylaxis group versus 84.6% in the reactive treatment group (odds ratio = 0.143, p = 0.04). No significant differences existed in incidence of other adverse reactions, including dry skin, pruritus, and paronychia. Incidence of grade 1 skin reactions was higher in the group that received prophylactic minocycline (p = 0.02). No significant differences in tumor response or time to treatment failure were observed.

The findings suggest that the prophylactic use of minocycline in patients receiving panitumumab may be helpful to reduce the incidence of more severe skin reactions.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• The use of topical steroids was at the investigator's discretion. The full components of general skin care were not described.

Prophylactic administration of tetracyclines may have some preventive effects in terms of skin toxicities with epidermal growth factor receptor inhibitiors; however, limited evidence exists to demonstrate efficacy. This small study provides limited evidence regarding this. Further well designed studies are needed to identify the efficacy of oral antibiotics and other aspects of skin care that are most beneficial to prevent skin effects from cancer treatment.

The purpose of the study was to evaluate the clinical efficacy of G-CSF and cost of daily versus every other day G-CSF for preventing and reducing duration of febrile neutropenia.

After treatment with the first course of R-CHOP, 100 mcg per person, G-CSF subcutaneously was begun when the white blood cell counts (WBC) were less than 1.5x10⁹/L and/or neutrophil counts were less than 0.5 x 10⁹/L. Patients were randomly assigned to receive G-CSF daily or every other day. Treatment was stopped when WBC recovered to greater than 5 x 10⁹/L. Total dosages and duration of G-CSF and any subsequent antibiotics were used for cost calculations

• 30 participants
• Mean age was 66 years, with a range = 24–80
• 53.3% were male; 46.7% were female
• All had diffuse large B-cell non-Hodgkin lymphoma and were receiving R-CHOP chemotherapy.  There was no bone marrow involvement
• All had ECOG performance status of 0–3.  Baseline WBC counts were similar in both groups
   

Single site

Active antitumor treatment

 Randomized, controlled trial

Recovery of WBC as defined required 4.0 ±1.4 days and 4.0±1.3 days in those receiving daily and every other day G-CSF respectively. Neutrophil count recovered in 3.4±1.1 days for those receiving daily treatment and in 3.6±1.4 days in those given G-CSF every other day. In the daily use group, three patients developed febrile neutropenia, and two patients in the every other day group developed febrile neutropenia. The same number of patients in each group who were given prophylactic antibiotics developed febrile neutropenia. Cost of treatment in those receiving daily G-CSF was significantly higher than cost in the every other day group (p < 0.0001).

There was no clinical difference in WBC and neutrophil recovery time between patients who were given daily or every other day G-CSF during a course of R-CHOP chemotherapy

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Limited study duration and duration of follow-up

Findings suggest that less frequent G-CSF administration may be as effective as daily administration to facilitate WBC and neutrophil recovery. Further larger scale research in this area is warranted.  If this approach is further supported, it can provide less costly care to achieve desired results.