To compare two techniques for pain relief with ​transrectal ultrasonography (TRUS)-guided biopsies

Patients undergoing prostate biopsies were randomized to receive either local infiltration anesthesia alone or a combination of local anesthesia and lignocaine 5% ointment to the anal rind, canal, and anterior rectal wall. Patients were asked to rate pain during insertion, during infiltration, and after biopsy.

• N = 163
• MEAN AGE = 61.7 years (range = 50–88 years)
• MALES: 100%         
• KEY DISEASE CHARACTERISTICS: All had elevated prostate-specific antigens

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

• PHASE OF CARE: Diagnostic

Randomized trial

• 100 mm Visual Analog Scale (VAS) for pain

Patients who received a combination of local and topical anesthesia reported significantly less pain (p = 0.005) at all stages of the procedure.

The combination of a local anesthetic infusion with a topical anesthetic may provide better pain control during biopsy.

• Risk of bias (no blinding)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: Data regarding pain differences were reported using different numeric scales, so the actual method of measurement and resulting analysis was unclear. It was unclear how patients during biopsy could reasonably use the VAS to report pain.

The combination of anesthetic infiltration and a local topical anesthetic may reduce pain during biopsy.

To determine whether a needleless closed system (NCS) is superior to the Luer cap system (LCS) in regards to the prevention of catheter-related bloodstream infection.

This was a retrospective study comparing the length of time from central venous catheter (CVC) insertion to the development of central-line associated blood stream infection (CLABSI) using LCS and then switching to NCS.

• N = 495
• AVERAGE AGE = 64.4 years
• MALES: 312/495 (63%), FEMALES: 183/495 (37%)
• KEY DISEASE CHARACTERISTICS: Colorectal cancer

• SITE: Single-site  
• SETTING TYPE: Multiple settings  
• LOCATION: Tochigi, Japan

• PHASE OF CARE: Active antitumor treatment

Retrospective analysis

The authors measured the time interval from CVC insertion to the development of CLABSI and compared a group of patients using LCS to a group using NCS. Centers for Disease Control (CDC) guidelines were used to define and diagnose CLABSI.

Using the Kaplan-Meier estimate and the log-rank test, the authors found that there was no significant difference between the LCS group and the NCS group in the time interval from CVC insertion to onset of CLABSI. Similarly, there was no significant difference in the incidence of CLABSI (p = 0.3), blood culture positivity (p = 0.836), and CVC tip positivity (p = 0.116) between the two groups.

There was no significant difference between the two groups in regard to blood culture positivity, CVC tip culture positivity, or the incidence of CLABSI. NCS did not demonstrate superiority in terms of prevention of CLABSI.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: There was a significant difference in sample size between the LCS and NCS groups; the authors also note significant differences between the two groups regarding gender, length of inserted catheter, duration of catheter insertion, use of surgery, chemotherapy administration, and administration of parenteral nutrition.

Although they were not shown to reduce CLABSI, NCSs are still recommended as a means of preventing needle-stick injuries.

• To perform a retrospective review of medical records to determine the use of prophylactic laxatives in patients receiving opioids.
• To determine the incidence of constipation in patients taking opioid medications.
• To promote use of preventative medications by educating physicians, checking orders, and educating patients.

In part 1, patients who were admitted and receiving opioids were surveyed for use of prophylactic laxatives to prevent constipation.

In part 2, prescribers were given drug information, orders were reviewed, and patients were educated about laxatives to manage constipation.

• The study reported on a sample of 83 patients with cancer in part 1 and 107 patients with cancer in part 2. 
• Mean patient age was 66.1 years (range 41-92) in part 1 and  63.7 years (range 14-83) in part 2. 
• The sample comprised 40 women and 43 men in part 1, and 40 women and 67 men in part 2.

• Single site
• Inpatient
• Japan

Patients were undergoing the active treatment phase of care.

This was a retrospective survey followed by an interventional study.

• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0
• Constipation medical records were reviewed.

• Of the 83 patients, 57% (47 patients) received laxatives with opioids.
• Patients who did not receive laxatives had a higher incidence of constipation than those who received laxatives (56% versus 21%, p = 0.0024).
• Patients who received laxatives had more bowel movements in seven days than patients who did not (5.6 versus 3.9, p = 0.005).
• Taking more laxatives resulted in less constipation, and the absence of prophylactic laxatives resulted in an increased risk of constipation.
• The incidence of constipation was lowest in patients who received prophylactic combination treatment with magnesium oxide and pantethine.

Laxative use prophylactically reduced the incidence of constipation in patients taking opioid therapy but did not completely prevent it.

• The study lacked an appropriate control group.
• Part 1 had fewer than 100 patients.
• The validity and reliability of medical records for determination of laxative use was questionable, and patients did not self-report use.

Laxative prophylaxis is beneficial to reduce the risk of opioid-induced constipation. Proactive interventions to increase laxative use may be beneficial to patients.

To evaluate the effectiveness of prophylactic laxatives and antiemetics on constipation, nausea, and vomiting in patients with cancer receiving opioids for the first time.

Medical records were reviewed from 2009 to 2010 for patients experiencing constipation, nausea, or vomiting during the first week of opioid analgesic administration. Number of stools recorded was used in the analysis. Constipation was defined as a stool-free interval of at least 72 hours during the first week. One episode of vomiting was counted as evidence of vomiting. Nausea grading was recorded for seven days.

• The study reported on a sample of 619 patients.
• Mean patient age was 66.8 years (range 53-81).
• The sample was 63% male and 37% female.
• Gastrointestinal and lung cancer were most prevalent, but the sample included a variety of disease sites.
• Most patients were receiving extended-release oxycodone.
• Patients were excluded if they were using transdermal opioids; undergoing surgery within the first week of receiving opioids; or experiencing continuous symptoms of constipation, nausea, or vomiting prior to opioid administration.

• Multi-site
• Setting type not specified
• Japan

• Patients were undergoing multiple phases of care.
• The study has clinical applicability to older adult and palliative care.

This was a descriptive, retrospective study.

National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 4.0, for nausea grading

• Incidence of constipation was 33.7% in those receiving prophylactic laxatives, compared to 54.6% in others (p < 0.001).
• The most frequently used laxative was magnesium oxide. Some patients also received senna and other combined laxatives. 
• No significant differences in efficacy existed among different laxatives.
• Regression analysis showed that no laxative use, use of morphine formulation, and being aged 70 years or older were predictive of constipation (p < 0.01).
• Odds ratio in favor of laxatives was 0.469 (95% confidence interval [0.231, 0.955], p = 0.037).
• No effects were observed for use of prophylactic antiemetics on nausea or vomiting. Antiemetics used were prochlorperazine, domperidone, and metoclopramide.

Use of prophylactic laxatives in patients receiving opioids for the first time was effective in reducing the risk and prevalence of constipation.

• A risk of bias existed because of the lack of random assignment.
• Measurement validity and reliability were questionable.
• The descriptive study design with dependence on medical record documentation limited the data's reliability.
• The duration of observation was short at only one week. Longer term efficacy is not known. 
• Dosages of opioids and other factors that could have contributed to constipation were not described.

Findings suggested use of prophylactic laxatives can reduce opioid-induced constipation during the first week in which patients receive opioids. Findings also suggested older patients may be at greater risk for opioid-induced constipation. Nurses can ensure that prophylactic regimens to prevent constipation are suggested for patients beginning opioid use and older adult patients.

To gain evidence regarding which regimen should be used for the management of highly emetogenic chemotherapy (HEC) induced chemotherapy-induced nausea and vomiting (CINV)

Patients were randomly assigned to the order of receiving either palonosteron and dexamethasone (PD) or aprepitant, granisetron, and dexamethasone (AGD) prophylaxis. The PD regimen was 0.75 mg palonosetron and 13.2 mg dexamethasone IV prior to treatment and 8 mg oral dexamethasone 24 and 48 hours later. The AGD regimen was 125 mg oral aprepitant and 3 mg granisetron and 6.6 mg dexamethasone IV before treatment, followed by 80 mg aprepitant and 4 mg dexamethasone at 24 and 48 hours. During the second cycle, patients were crossed over to the alternative regimen. During cycle 1, CINV and the use of rescue antiemetics were evaluated. After crossover, patients were asked which treatment was more effective and preferred. Rescue medications were metoclopramide or prochlorperazine.

• N = 84   
• MEDIAN AGE = 64.5 years
• AGE RANGE = 30–77 years
• MALES: 79.8%, FEMALES: 20.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Most patients had stage IV disease
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were chemotherapy naïve and were scheduled to receive two or more cycles of chemotherapy including cisplatin at 60 mg/m² or more.

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

• PHASE OF CARE: Active antitumor treatment

• Randomized crossover trial

• Common Terminology Criteria for Adverse Events (CTCAE)
• Functional Living Index-Emesis (FLIE) questionnaire
• Complete response rate for acute, delayed, and overall phases defined as no emesis and no use of rescue medications

No significant differences existed between treatment regimens for complete response in the acute phase. The complete response (CR) rate was higher in the delayed (p = 0.025) and overall phases (p = 0.025) in the regimen including aprepitant. Less than 40% with either treatment had no nausea. FLIE scores indicating impact on daily life showed that more patients in the aprepitant-based regimen group were not affected by nausea (p = 0.014). Forty-one percent indicated preference for AGD, 19.7% preferred PD, and 39.3% indicated no preference.

Findings suggest that a CINV prophylactic regimen containing an NK1—in this case, aprepitant—was more effective in preventing CINV than a regimen of palonosetron and dexamethasone alone.

• Data collection methods for response rates were not reported.

Findings support the use of a triple drug regimen of a 5HT3, NK1, and dexamethasone for patients receiving HEC. Nausea in the delayed phase continues to be an ongoing problem that is not completely relieved with these regimens. Further research is needed to identify other adjuvant medications to address nausea.

To evaluate the effectiveness of calcium/magnesium (Ca/Mg) infusions in reducing the incidence and severity of oxaliplatin-related neurotoxicity and to evaluate the effects of Ca/Mg infusions on progression-free survival and platinum plasma levels in patients with colorectal cancer

Patients with metastatic colorectal cancer were randomized and double-blinded to receive mFOLFOX6 with a Ca/Mg infusion (100 ml of 5% glucose-containing calcium gluconate of 850 mg and magnesium sulfate of 720 mg) before and after the administration of oxaliplatin or mFOLFOX6 with placebo (100 ml of 5% glucose alone) before and after administration of oxaliplatin (85 mg/m²) every two weeks for six cycles. Prior to administration, patients were assessed for adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, by nurses or pharmacists.

• N = 33 (17 [Ca/Mg group], 16 [control group])
• MEAN AGE = 63 years (Ca/Mg group), 64 years (control group)
• MALES: 49%, FEMALES: 51%
• KEY DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer with either unresectable metastasis or prior resection of metastatic lesions
• OTHER KEY SAMPLE CHARACTERISTICS: Bone marrow, liver, and kidney function normal in all subjects; World Health Organization performance status of 0–2; no multiple cancers or history of radiotherapy; no differences in age, sex, number of mFOLFOX6 cycles, relative dose intensity, or number of metastatic organs between placebo and Ca/Mg group

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Japan-Saitama Medical Center

• PHASE OF CARE: Advanced
• APPLICATIONS: Elder care, palliative care 

Prospective, randomized, double-blind, controlled trial in patients with metastatic colorectal cancer receiving mFOLFOX6

• Adverse events were evaluated by nurses and pharmacists before the start of administration according to the CTCAE, version 3.0, and DEB-NTS, although only the data from baseline and after six cycles were provided.
• Response Evaluation Criteria in Solid Tumors (RECIST) criteria was used to evaluate treatment outcomes and compare between groups.
• Plasma platinum levels (blood samples) were drawn five minutes, one hour, three hours, and two weeks after the first cycle and five minutes, one hour, and two weeks after the fifth cycle for comparison.

Ca/Mg infusion prior to and after mFOLFOX6 did not reduce the incidence of grade 1–3 neurotoxicity using two different standardized measures for neurotoxicity (DEB-NTS and CTCAE) after the completion of six cycles; response rates, disease control rates, and median survival times were not significantly different between groups. No significant differences existed in the plasma platinum levels between groups (Ca/Mg versus placebo) at any time point using the pre-established significance value of p < 0.05. Also, no significant difference in plasma platinum levels existed in those who developed grade 2 neuropathy compared to those who developed less severe neuropathy (DEB-NTS). When comparing those who achieved a partial or complete remission with mFOLFOX6 to those who achieved no response, plasma platinum levels did not differ, suggesting that calcium and magnesium infusions did not influence the efficacy of mFOLFOX6 chemotherapy.

Ca/Mg infusions before and after oxaliplatin did not reduce the incidence or severity of neurotoxic symptoms in patients with metastatic colorectal receiving mFOLFOX6.

• Small sample (< 100)
• Risk of bias(sample characteristics)
• Findings not generalizable
• The study was terminated prematurely prior to completion of enrollment because of an interim analysis of the CONCEPT study reporting that treatment with Ca/Mg decreased antitumor activity.
• No explanation of history or presence of neurotoxic symptoms prior to the start of treatment for either group
• Unclear if patients were on medication or treatment for neuropathy
• Limited information for inclusion/exclusion criteria
• Unclear if all patients completed six cycles of mFOLFOX6
• Mann-Whitney test comparing continuous variables has limited statistical inference.
• No reliability or validity information provided for the primary measure of neuropathy (NEB-NTS)
• Lack of power to detect statistical significance because of small sample size

The administration of Ca/Mg before and after oxaliplatin as a preventive measure to reduce the incidence or severity of oxaliplatin-related peripheral neuropathy in patients with colorectal cancer receiving mFOLFOX6 for six cycles has no clinical benefit.

To investigate the effects of single-dose versus multiple-dose antimicrobial prophylaxis on surgical site infections (SSI) in patients undergoing elective surgery for rectal cancer

All patients received a preoperative bowel cleansing, kanamycin and erythromycin orally within 24 hours prior to surgery, and 1 g of a second-generation cephalosporin IV perioperatively. After surgery, patients were randomized to receive either single-dose prophylaxis one hour after surgery or an additional five doses over two consecutive days. Wounds were inspected daily in the hospital and in the clinic 30 days after surgery. The trial was designed to detect a 10% difference in the incidence of SSIs between groups.

• N = 279  
• MEAN AGE = 65 years (range = 33–91 years)
• MALES: 64.5%, FEMALES: 35.5%
• KEY DISEASE CHARACTERISTICS: All patients had rectal cancer; the majority had anterior resections
• OTHER KEY SAMPLE CHARACTERISTICS: None of the patients had preoperative chemotherapy or radiation therapy.

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

• PHASE OF CARE: Active antitumor treatment

Noninferiority randomized, controlled trial

• SSIs were recorded according to Centers for Disease Control (CDC) definitions for incision site and organ/space infections

The incidence of incision site infections was 5% in the single-dose group and 7.1% in the multiple-dose group. Organ/space infections were 10.8% in the single-dose group and 8.6% in the multiple-dose group. Several organ/space infections were related to anastomotic dehiscence. Overall, the incidence of SSIs was 13.7% with single-dose prophylaxis and 13.6% with multiple-dose prophylaxis. Subgroup analysis by specific surgical procedure did not show any significant differences between groups.

Single-dose, postoperative, intravenous, antimicrobial prophylaxis demonstrated similar results to that of multiple-dose prophylaxis. Multiple antimicrobial doses did not show improved benefit for the prevention of surgical site infections

• Risk of bias (no blinding)

A single dose of IV antibiotic prophylaxis after rectal surgery for cancer had similar outcomes to that of multiple postoperative antibiotic doses. These findings show there is no benefit to more doses of prophylactic postoperative antibiotics for the prevention of SSIs.

Patients were assigned randomly to receive either placebo or interleukin-11 (IL-11) 50 mcg/kg/day subcutaneous (SC). The study drug was blinded. Randomization was stratified by investigative site and also by whether patients had received any prior chemotherapy. SC administration began on day two and was given for a minimum of 10 days after the first cycle of chemotherapy.

• N = 77     
• AGE: Older than 18 years of age
• WOMEN: 100%
• KEY DISEASE CHARACTERISTICS: Stage 2, 3, or 4 breast cancer and Eastern Cooperative Oncology Group (ECOG) status of 0–2
• OTHER KEY SAMPLE CHARACTERISTICS: Patients treated with cyclophosphamide (3200 mg/m²) and doxorubicin (75 mg/m²) IV on same day; chemotherapy repeated every 21–28 days

• Randomized, blind study

• The primary endpoint was whether a patient required platelet transfusions during two cycles of chemotherapy.
• Time to platelet recovery, open-label treatment, tumor response, time to neutrophil recovery, antibody development, safety, and efficacy

Sixty-seven patients were assessable. Sixty-eight percent of patients in the IL-11 group did not receive transfusions, versus 41% in the placebo group (p = .04). The IL-11 group had a decreased total number of platelet transfusions (p = .03) and time to platelet recovery to greater than 50K in the second cycle (p = .01). Side effects in the IL-11 group (p < .05) were peripheral edema (68%), dyspnea (48%), pleural effusion (18%), and conjunctival infection (25%).

• All female patients
• Only high-risk and advanced
• Well-controlled
• Did not demonstrate for dose intensity, maintenance of planned schedules
• Open-label so everyone could crossover
• Did not address how people stayed on track for schedule
• IL-11 for first two cycles
• How many women went on to get planned schedules?
• Where was the science in 1997?

To examine the effects of an exercise intervention on the severity of aromatase inhibitor (AI)-induced arthralgia in women with breast cancer

Patients were randomly assigned to a year-long exercise program consisting of twice weekly supervised resistance training and home-based aerobic exercise for 150 minutes per week. Participants wore heart rate monitors during workouts, and after each exercise session, participants recorded exercise type, duration, and average heart rate in logs. The aerobic component was usually brisk walking although patients could choose other activities such as stationary bike use. Strength training consisted of six exercises with gradually increasing weight. Women in the usual care group were instructed to continue usual activities. Those in the usual care group received monthly phone calls to determine AI adherence. 

• N = 107 (completed six months), 24 (completed 12 months)
• MEAN AGE = 61.3 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving AIs; 60% had stage 1 disease 
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants were Caucasian (88%). Women who were physically active were excluded.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: New England, United States

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled trial

• Brief Pain Inventory (BPI)
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMUOI)
• Disabilities of the Arm Shoulder and Hand (DASH) questionnaire 
• Grip strength 

Women assigned to exercise increased their physical activity by an average of 159 minutes per week compared to an average of 49 minutes per week in the usual care group (p < 0.001). Over 12 months, worst joint pain decreased by 29% in the exercise group while usual care patients showed a 3% increase (p < 0.001). The same patterns were shown in the DASH and osteoarthritis index measures. There was no dose response from exercise effects on arthralgia pain or functional measures. Adherence to AIs was 76% in the usual care group and 80% in the exercise group. AI-associated joint pain worsened slightly over time in the usual care group. The strongest benefit of exercise was seen after 12 months.

The findings of this study suggested that an exercise program including aerobic, resistance, and strength training may reduce pain from arthralgia caused by AIs among women with breast cancer.

• Small sample (< 30)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: More patients in the usual care group did not complete the study.

Exercise has been recommended for patients with cancer to ameliorate multiple symptoms. This study showed that exercise also can reduce arthralgia-related pain associated with AIs and improve function among breast cancer survivors. Nurses can educate patients regarding the numerous benefits of exercise and can encourage and recommend regular exercise.

Compare the efficacy of 3 drugs in preventing hot flashes in men receiving  hormone treatment for prostate cancer

Patients were randomly assigned to receive wither venlafaxine delayed release 75 mg/day, medroxyprogesterone 20 mg/day or cyproterone acetate 100 mg/day in addition to leuprorelin injections.  Patients were followed up at 4, 8 and 12 weeks.  Patients completed daily hot flush diaries and categorised hot flush severity

• N  309 AGE   Not reported
• MALES (%) 100%         FEMALES (%)
• KEY DISEASE CHARACTERISTICS All had prostate cancer treated with hormonal therapy for at least 6 months.  All had experienced 14 or more hot flushes in the week before study entry

 Double blind randomized controlled trial

• Daily hot flush diary
• European Organization for Research and Treatment of Cancer Quality of life questionnaire ( EORTC-QLC 30)
   

Patients in the medroxyprogesterone group had higher hot flash scores at baseline.  The reduction in daily hot flush scores at 4 weeks was significantly lower for all 3 groups (p<.0001).  Improvements were significantly lower in the venlafaxine group than either of the other 2 groups ( p = .0006), and patients ratings of efficacy of treatment showed that significantly fewer patients in the venlafaxine group rated the treatment as good ( p<.0001) compared to the other 2 groups. Adverse events related to the study drugs were not significantly different between groups, though cyproterone led to a non significantly higher number of vascular adverse events.  The most frequent adverse events were gastrointestinal, including pain, constipation, diarrhea and nausea.  GI events were more frequent with venlafaxine.

Men with significant hot flushes during androgen suppression for prostate cancer appeared to respond better to cyproterone acetate and medroxyprogesterone acetate than to venlafaxine

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Other limitations/*explanation  No control or placebo group precluded observation of placebo effect.  The sample was limited to patients who sought treatment for hot flashes.  This was a short follow up period - longer term efficacy is not known. Effects of hormonal treatment for hot flashes on prostate cancer are not known.

It appears that hormonal treatment is more effective in than venlafaxine for management of hot flashes in patients who are receiving androgen suppression for prostate cancer.  Results also showed that many men did not seek treatment for this problem, suggesting that nurses may need to directly assess these patients for problems with hot flash symptoms.  Effects of steroidal anti androgens on prostate cancer are not clear, and patients receiving both androgen suppression and cyproterone or medroxyprogesterone could have increases in prostate specific antigen concentrations.