Zielinski, J., Jaworski, R., Smietanska, I., Irga, N., Wujtewicz, M., & Jaskiewicz, J. (2011). A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast. Medical Science Monitor: International Medical Journal of Experimental and Clinical Research, 17(10), CR589–597.
To test the effect of bupivacaine, applied in the area of surgical incision, on the pain experienced by postmastectomy patients; to see how the bupivacaine affected use of analgesics
Before mastectomy, women were randomized to receive bupivacaine application or saline placebo. The bupivacaine group received 100 mg bupivacainum hydrochloricum dissolved in normal saline. The control group received normal saline. Bupivacaine and saline were administered in the same way: subcutaneously, along the intended line of incision, 15 minutes before the operation. All patients received standard oral premedication: 7.5 mg midazolam. Anesthesia consisted of propofol, 2 mg/kg body weight; vecuronium, 0.6 mg/kg; and fentanyl, 2 mcg/kg. After surgery, each patient had the option of patient-controlled analgesia, which consisted of standard drug concentrations based on body weight. IV metamizole, 1g, was administered every 6 hours. Pain was measured at 1, 2, 3, 4, 8, 12, 16, 20, 24, 36, and 48 hours postoperatively. Total analgesic consumption was recorded.
Active treatment
Randomized double-blind placebo-controlled trial
Visual analog scale (VAS), with a 0–10 scale, to measure pain severity
Compared to patients receiving placebo, patients receiving bupivacaine reported significantly lower pain severity at the 4th (p = 0.004) and 12th p = 0.02) postoperative hours. Patients receiving bupivacaine used less fentanyl (p = 0.011). Between the 4th and 12th postoperative hours, those receiving bupivacaine used less PCA morphine (p = 0.02) than did the control group. The pattern of VAS scores was similar in both groups, with a spike in pain during the first postoperative hour and a gradual decline thereafter. Across the first 12 hours, pain scores in the bupivacaine group were consistently lower than the scores in the control group. Authors noted no differences between groups in regard to time to first morphine dose or total amount of morphine used during the postoperative follow-up.
Preoperative subcutaneous injection of bupivacaine to the site of surgical incision was effective in reducing patients' pain severity and morphine consumption during the first 12 hours after mastectomy.
Findings provide support for the use of bupivacaine injection to relieve postmastectomy pain. Nurses can advocate for consideration of this approach as part of surgical pain management. Note that these results are not immediately generalizable to other surgical populations.
Zidan, J., Haim, N., Beny, A., Stein, M., Gez, E., & Kuten, A. (2001). Octreotide in the treatment of severe chemotherapy-induced diarrhea. Annals of Oncology, 12(2), 227–229.
Patients with chemotherapy-induced diarrhea (CID) refractory to loperamide received 100 mcg subcutaneous octreotide three times per day for three days followed by 50 mcg three times per day for three days. The median time between chemotherapy and starting octreotide was 8 days (range = 5–9 days).
This was a prospective study.
Patients recorded the number of bowel movements. Complete response (CR) was defined as no diarrheal stools per day; partial response (PR) was defined as 1–2 diarrheal stools per day; and no response was defined as three or more diarrheal stools per day. Progression was defined as an increase in the number of diarrheal stools.
Octreotide was found to be highly effective as second-line therapy in managing patients with CID.
The sample size was small.
Zick, S.M., Sen, A., Wyatt, G.K., Murphy, S.L., Arnedt, J.T., & Harris, R.E. (2016). Investigation of 2 types of self-administered acupressure for persistent cancer-related fatigue in breast cancer survivors: A randomized clinical trial. JAMA Oncology, 2, 1470–1476.
To identify improvement in fatigue, sleep, and quality of life in breast cancer survivors using self-administered acupressure
Self-administered relaxing acupressure or stimulating acupressure performed once daily for three minutes for six weeks. Assessments were conducted at baseline, three weeks (to assess technique), six weeks (end of intervention), and 10 weeks (washout).
Self-administered relaxing and stimulating acupressure may improve fatigue in breast cancer survivors who have completed treatment at least 12 months ago. Relaxing acupressure may also improve sleep and quality of life in this patient group.
Self-administered relaxing and stimulating acupressure may be beneficial in the reduction of fatigue in breast cancer survivors who have completed treatment at least 12 months ago. Additional studies could be conducted with those currently receiving treatment and with patients with other cancers.
Zick, S.M., Ruffin, M.T., Lee, J., Normolle, D.P., Siden, R., Alrawi, S., & Brenner, D.E. (2009). Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Supportive Care in Cancer, 17, 563–572.
To evaluate the efficacy of ginger in relief of delayed chemotherapy-induced nausea and vomiting (CINV)
Patients with cancer who had experienced CINV during at least one previous round of chemotherapy were asked to participate. All participants were receiving a 5-HT3 receptor antagonist or aprepitant as part of their standard antiemetic regimen. Patients were randomized to receive either 1.0 g of ginger, 2.0 g of ginger, or matching placebo daily for three days.
The study was conducted at multiple outpatient settings in Ann Arbor, MI.
All patients were in active treatment.
This was a randomized double-blind, placebo-controlled trial.
The Morrow Assessment of Nausea and Emesis (MANE) and the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 for Adverse Events were used.
Ginger extract provides no clinical benefit at the doses evaluated when given in addition to standard, evidence-based medical therapy to prevent CINV. Ginger extract may have a negative effect on severity of nausea when taken with aprepitant.
Ziakas, P.D., Kourbeti, I.S., Voulgarelis, M., & Mylonakis, E. (2010). Effectiveness of systemic antifungal prophylaxis in patients with neutropenia after chemotherapy: a meta-analysis of randomized controlled trials. Clinical Therapeutics, 32, 2316–2336.
To estimate the impact of antifungal prophylaxis on the occurrence of proven systemic fungal infections in patients with neutropenia and to quantify its effect on mortality attributed to these infections.
Databases searched were MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through September 15, 2010. In addition, proceedings of the annual meetings of the Infectious Diseases Society of America (2001–2009), the American Society of Hematology (2000–2009), and the European Society of Clinical Microbiology and Infectious Diseases (2000–2010) were manually reviewed.
Search keywords were clinical trial(s), neutropenia, neoplasms, malignant, malignant neoplasm, mycoses, candida, aspergillus, zygomycosis, antifungal agents/antifungal, ketoconazole, fluconazole, itraconazole, voriconazole, posaconazole, amphotericin B, miconazole, and micafungin.
Articles were included if they focused on patients undergoing treatment for cancer who received prophylactic antifungal medications.
Articles were excluded if they directly compared systemic antifungal prophylactic agents, evaluated nonabsorbable polyenes or oral antifungal formulations of amphotericin B, and did not evaluate antifungals prophylactically (i.e., those that included empirical, pre-emptive, or salvage therapies for fungal mycoses).
A total of 11,418 references were retrieved.
A meta-analysis method of study was used. In specific, statistical analysis was performed to compare study results, including effects of antifungal prophylaxis using random effects and reported as pooled odds ratios (ORs) and 95% confidence intervals (CIs) using the Robins-Breslow-Greenland formula. For study cells with zero events, an ad hoc treatment arm continuity correction was used. Findings in which the 95% CI crossed 1 were not considered statistically significant. Statistical heterogeneity was assessed using the I2 statistic and Cochrane Q test. The Petro method was used for sensitivity analysis, and the Harbord modification of the Egger test was used to evaluate small study effects for major outcomes.
Patients were undergoing the active treatment phase of care.
Antifungal prophylaxis was associated with statistically significant reductions in proven fungal infections (OR = 0.43; 95% CI [0.31, 0.6]; number needed to treat [NNT] = 20) and mortality attributed to fungal infections (OR = 0.49; 95% CI [0.3, 0.8]; NNT = 53), reduction in risk for proven candida infections (OR = 0.28; 95% CI [0.2, 0.38]), and a decreased need for antifungal therapy (OR = 0.64; 95% CI [0.48, 0.86]). Explanatory subanalysis of major outcomes showed a reduced risk for proven infections among HSCT recipients only (OR = 0.27; 95% CI [0.16, 0.44]) and infection-related mortality (OR = 0.41; 95% CI [0.21, 0.81]). Not statistically significant were overall mortality (OR = 0.92; 95% CI [0.74, 1.14]) or reduction of aspergillosis or zygomycosis. Meta-regression analysis showed that multi-center and double-blind designs were significant moderators of the effect of antifungal prophylaxis on overall mortality and proven systemic fungal infections.
Systemic antifungal prophylaxis was associated with decreased proven fungal infections and fungal infection-related mortality in patients with neutropenia following chemotherapy. Antifungal prophylaxis was also associated with decreased proven infections and infection-related mortality in HSCT recipients. Overall mortality was not improved through the use of antifungal prophylactic therapy.
The use of prophylactic antifungal therapy should be considered for patients receiving neutropenic-inducing chemotherapy and/or those undergoing HSCT.
Zhu, G., Lin, J.C., Kim, S.B., Bernier, J., Agarwal, J.P., Vermorken, J.B., . . . He, X. (2016). Asian expert recommendation on management of skin and mucosal effects of radiation, with or without the addition of cetuximab or chemotherapy, in treatment of head and neck squamous cell carcinoma. BMC Cancer, 16, 42-016-2073-z.
RESOURCE TYPE: Consensus-based guideline
PROCESS OF DEVELOPMENT: Asian expert panel of head and neck cancer specialists
PHASE OF CARE: Active treatment
This review and expert opinion were limited to patients with head and neck squamous cell carcinoma undergoing radiation therapy with or without cetuximab or chemotherapy. The authors’ proposal of a new grading system was noted to be adapted from the authors who previously addressed the need for a new grading system.
Zhu, M., Liang, R., Pan, L.H., Huang, B., Qian, W., Zhong, J.H., . . . Li, C.L. (2013). Zoledronate for metastatic bone disease and pain: A meta-analysis of randomized clinical trials. Pain Medicine, 14, 257–264.
STUDY PURPOSE: To determine the efficacy and safety of zoledronate in treating pain related to metastatic bone disease
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: PubMed, EMBASE, and the Cochrane Library up to October 2011
KEYWORDS: Zoledronic acid and bone metastasis, and these two terms in combination with zoledronate and bone pain
INCLUSION CRITERIA: Patient had at least one site of bone metastasis; Eastern Cooperative Oncology Group performance status of 2 or less; the study evaluated the effects of at least one type of zoledronate on skeletal-related events (SREs) or bone pain in patients with any type of metastatic bone disease; study was a placebo-controlled RCT; and study reported Brief Pain Inventory (BPI) scores at all time points examined
EXCLUSION CRITERIA: None listed
TOTAL REFERENCES RETRIEVED = 150 studies
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers used the Jadad composite scale to score the methodologic quality of the studies for the studies that were included in the analysis
Ten of the 12 RCTs provided data on SREs. Patients receiving zoledronate had a significantly lower rate of SREs than the placebo group (RR 0.75, 95% Cl 0.69–0.81, p < 0.001). Six studies that reported BPI scores found the zoledronate group to have significantly reduced scores at three months (WMD -0.53, 95% Cl -0.72–-0.35, p < 0.001), 12 months (WMD 0.39, 95% Cl -0.62–-0.16, p < 0.001), and 24 months (WMD -0.48, 95% Cl -0.77–-0.19, p < 0.001). The incidence of pyrexia (RR 1.43, 95% Cl 1.12–1.70, p < 0.001), fatigue (RR 1.26. 95% Cl 1.11–1.43, p < 0.001), and anemia (RR 1.33. 95% Cl 1.14–1.55, p < 0.001) was higher in the zoledronate group than the placebo group for the pooled results from five to six studies.
Zoledronate was more effective in preventing SREs and bone pain than a placebo for up to 24 months in patients with metastatic bone disease. Adverse effects were a class effect related to bisphosphonates; thus, they were not specific to zoledronate. Renal effects, which are associated with this classification of drugs, were not found to be a significant adverse event among patients in these studies receiving 4 mg zoledronate in a 15-minute infusion.
A limitation was that 50% of the studies (n = 6) included in the meta-analysis received a low quality score of 2 or less. However, the authors did report that a sensitivity analysis of the pooled results was unchanged with the removal of these studies’ data from the analysis.
Nurses need to be knowledgeable about the potential adverse effects of zoledronate (more common: pyrexia, fatigue, and anemia; less common: nausea and emesis), which are the same adverse effects of other bisphosphonates. In addition, to prevent renal toxicity, the dose should not be more than 4 mg and should be delivered IV in a 100 ml solution over 15 minutes. Lastly, nurses should be aware that patients can safely receive this drug every three weeks over a period of 24 months with continued pain relief and prevention of SREs.
Zhu, Z., Wang, C., Xu, C., & Cai, Q. (2013). Influence of patient-controlled epidural analgesia versus patient-controlled intravenous analgesia on postoperative pain control and recovery after gastrectomy for gastric cancer: A prospective randomized trial. Gastric Cancer, 16, 193–200.
To compare effects of patient-controlled epidural analgesia (PCEA) and patient-controlled IV analgesia (PCIA) after surgery for gastric cancer
Patients undergoing radical gastrectomy were randomized to receive either PCEA or PCIA. Patients receiving PCEA had a catheter inserted at T8–9 before anesthesia induction and postoperatively received an infusion of .05% bupivacaine and 100 mcg/ml morphine at a basal rate of 4 ml per hour for 48 hours, supplemented with rescue boluses of 4 ml with a 30-minute block-out period. The PCIA group received morphine at a basal rate of 1 mg per hour with rescue boluses of 1 mg every 10 minutes as needed. The primary outcome was postoperative pain at rest on day 1 after surgery.
The mean pain scores in the PCEA group on days 1 and 2 were 2.9 (p < .01) and 2.3 (p < .05), respectively, compared to scores of 3.8 and 3.3, respectively, in the PCIA group. Pain on coughing was also significantly lower in the PCEA group (p < .05). Time to passage of flatus was lower in the PCEA group (p < .05), with 0.8 days' difference on average. Patients receiving PCEA had an average 10.7-day hospital stay, compared to 11.9 days in the PCIA group (p < .05). No differences were seen in post-operative complications between groups.
Findings show that post-operative analgesia with PCEA resulted in better pain control and lower hospital stay compared to analgesia with PCIA.
Epidural analgesia may provide better post-operative pain management than IV analgesia. Nurses need to know how to care for and monitor potential complications with the use of epidural catheters.
Zhou, K.N., Li, X.M., Yan, H., Dang, S.N., & Wang, D.L. (2011). Effects of music therapy on depression and duration of hospital stay of breast cancer patients after radical mastectomy. Chinese Medical Journal, 124(15), 2321–2327.
To study the effects of music therapy on depression in female patients with breast cancer after radical mastectomy; to study how music therapy affects duration of hospital stay
Subjects were randomly assigned to a music or usual-care group (control). Investigators collected data on the day before radical mastectomy (pretest), the day before hospital discharge (first post-test), and at the second and third hospital admissions for chemotherapy (second and third post-tests). Different chemo intervals meant that the second and third post-tests were between 14 and 28 days; the mean time was 18.6 days (SD = 7.4 days). Total intervention time involved the hospital stay after radical mastectomy (mean 13.6 days [SD = 2 days]) and the two chemotherapy periods (the mean time of each period was 8.9 days (SD = 7.1 days). The experimental group received an introduction to music, and participants selected preferred music. Each participant listened to his or her choice of music through headphones connected to an MP3 player. Participants listened to music twice a day, 30 minutes each time. Investigators did not offer music to the control group.
Randomized controlled trial with repeated measures
Postmastectomy, depression scores of the experimental group were lower than those of the control group, and duration of hospital stay was shorter for patients receiving music therapy. However, lack of data regarding actual use of music therapy by patients and lack of information regarding patients’ health status and other types of treatment preclude recommendation of music therapy without further study.
When caring for patients with breast cancer who are suffering from mood disturbance, nurses should select interventions whose evidence of mood-disturbance reduction is greater than the evidence of effect that listening to music presents. However, listening to music is a low-risk, low-cost intervention that might be helpful to some patients.
Zhou, Y., Peng, L., Li, Y., & Chen, L. (2013). Prophylactic pyridoxine was not able to reduce the incidence of capecitabine-induced hand-foot syndrome: A meta-analysis. Biomedical Reports, 1, 873–878.
PHASE OF CARE: Active antitumor treatment
Prophylactic pyridoxine did not reduce the incidence of capecitabine-induced HFS of any grade (OR = 0.91; 95% CI: 0.67–1.24), of ≥ grade 2 HFS (OR = 1.17; 95% CI: 0.82–1.67), or ≥ grade 3 HFS (OR = 1.05; 95% CI: 0.60–1.85).
Pyridoxine is not effective at preventing HFS associated with capecitabine.
Prophylactic pyridoxine is not an effective intervention to prevent HFS in patients receiving capecitabine.