Kang, H.C., Ahn, S.D., Choi, D.H., Kang, M.K., Chung, W.K., & Wu, H.G. (2014). The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: Results from a multicenter observational study. Radiation Oncology Journal, 32, 156–162.
To evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in patients with cancer
EasyDew CR cream (0.005% rhEGF, ceramide, hyaluronic acid, Inca omega oil, portulaca oleracea extract, mango butter, and meadowfoam oil) was applied to the radiation portal skin twice per day from day 1 to the last day of radiation treatment (RT). Patients were advised to wash the cream off prior to RT. No other prophylactic creams or lotions were allowed, and additional applications were ceased if an adverse reaction occurred because of the rhEGF-based cream. Compliance in applying the cream was evaluated weekly by the treating radiation oncologist.
Multi-site, prospective, observational study of the efficacy and safety of rhEGF cream to prevent radiodermatitis (in patients receiving more than 50 Gy of external radiotherapy)
This study showed that the intervention used was not associated with any severe adverse reactions, but it provides no real evidence regarding the efficacy of the rhEGF cream.
Additional studies of this cream are needed before considering the use of this cream in practice. The authors addressed pruritus and radiation toxicity as being potential adverse events; however, they do not stress the importance. Pruritus has been demonstrated to negatively impact quality of life.
Kang, J.H., Kwon, J.H., Hui, D., Yennurajalingam, S., & Bruera, E. (2013). Changes in symptom intensity among cancer patients receiving outpatient palliative care. Journal of Pain and Symptom Management, 46, 652–660.
To determine symptom changes after outpatient palliative care
Patients who were seen in outpatient palliative care and had completed a symptom assessment scale were included in retrospective review of medical records. Only patients who completed the assessment and had at least one follow-up visit were included. The outpatient palliative care service was provided by an interdisciplinary team. Baseline symptom severity was compared to findings on an initial follow-up—usually in 15 days—and compared to a group of patients not eligible for study inclusion.
Of the patients, 52%–74% had improvement in intensity of symptoms of pain, fatigue, depression, anxiety, anorexia, shortness of breath, and sleep disruption. Overall, among patients who had no or mild symptoms at baseline, symptom intensity was worse at follow-up, and among those with moderate or severe symptoms, symptom intensity declined at follow-up. Of patients with moderate or severe symptoms, 48%–80% continued to have clinically significant symptom intensity at follow-up. Median scores for pain, fatigue, depression, anxiety, anorexia, dyspnea, and sleep disturbance improved by at least one point by the first follow-up (p < .001).
Outpatient palliative care services in this setting were associated with reduced symptom intensity among patients who had moderate to severe symptoms. Findings suggest that the timing of initial follow-up might not be sufficient to significantly reduce symptom burden quickly.
Findings suggest that provision of outpatient palliative care services can be beneficial in reducing symptom burden among patients with cancer. Because 48%–80% still had relatively high intensity of symptoms at follow-up after 15 days—and those with no or mild symptoms had exacerbation of symptoms at follow-up—a shorter initial follow-up period might achieve more rapid improvement and help to prevent exacerbation of symptoms. Findings also suggest that getting more severe symptoms under control may take longer, pointing to the need for nurses to consider involvement of palliative care specialists early in the course of cancer treatment.
Kang, H.J., Loftus, S., Taylor, A., DiCristina, C., Green, S., & Zwaan, C.M. (2015). Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: A randomised, double-blind, phase 3 trial. Lancet Oncology, 16, 385–394.
To assess the efficacy and safety of oral formulations of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients aged six months to 17 years scheduled to be treated with moderately or highly emetogenic chemotherapy
Patients were randomly assigned (but stratified by age) to the aprepitant or control regimen and were divided into two age groups: less than 12 and 12–17 years. All patients received ondansetron. Patients over 12 received a 125 mg aprepitant capsule on day 1 and 80 mg on days 2 and 3 in the aprepitant arm. The control arm received a placebo daily plus ondansetron on day 1. Patients under 12 in the aprepitant arm received powder for suspension at 3 mg/kg on day 1 with ondansetron and 2 mg/kg of aprepitant on days 2 and 3. The control regimen again received a placebo daily plus Zofran on day 1. Investigators were able to add dexamethasone at their discretion with dose reductions of 50% based on adult pharmacokinetic data.
Phase 3, multicenter, randomized, double-blinded, active-comparator, controlled, parallel-group trial
Fifty-one percent of patients in the aprepitant group achieved a complete response in the delayed phase versus 26% in the control group (p < 0.0001). The number of patients with no vomiting or rescue medication use was greater in the aprepitant group than the control group in all phases (47% versus 21% for no vomiting and 66% versus 49% for no rescue medication). The median time till the first vomiting episode was greater in the aprepitant group (96.3 hours versus 27.5 hours), and the time to first rescue medication use also was significantly longer in the aprepitant group compared to the control group. The number of patients who achieved a complete response was similar for patients aged less than 12 years receiving a powder suspension and those who received capsules. Adverse events were reported equally between groups. Serious adverse events were reported in 30% of the aprepitant group and 27% of the control group (most commonly febrile neutropenia).
A three-day age and weight adjusted oral aprepitant regimen given in combination with ondansetron with or without dexamethasone safely provided a significant benefit in preventing CINV in moderately to highly emetogenic chemotherapy in a pediatric population.
The addition of aprepitant to ondansetron with or without dexamethasone was safe and may be effective in the prevention of CINV in pediatric patients receiving moderately to highly emetogenic chemotherapy.
Kanda, Y., Yamamoto, R., Chizuka, A., Hamaki, T., Suguro, M., Arai, C., . . . Togawa, A. (2000). Prophylactic action of oral fluconazole against fungal infection in neutropenic patients. A meta-analysis of 16 randomized, controlled trials. Cancer, 89, 1611–1625.
To evaluate the efficacy of fluconazole prophylaxis during chemotherapy-induced neutropenia.
Databases searched were MEDLINE, CancerLit, and the Pfizer company database through April 1999 (no start date was provided). The search was not restricted to the English language or published trials.
Sixteen trials were evaluated.
Studies were included if they
Data from the meta-analyses reported the combined population, bone marrow transplant (BMT) recipients only, and non-BMT recipients only.
A total of 3,734 patients were evaluated. Some studies exclusively examined BMT recipients, others studied non-BMT recipients, and others evaluated a combined population.
Prophylactic fluconazole was not effective in
Prophylactic fluconazole was effective in
Prophylactic fluconazole did not increase rates of proven systemic infection with resistant strains in the non-BMT or BMT populations.
Colonization of fluconazole-resistant fungi increased with prophylactic treatment in BMT recipients; however, information about non-BMT recipients is inconclusive because of lack of power and paucity of data.
Kanazawa, S., Yamaguchi, K., Kinoshita, Y., Muramatsu, M., Komiyama, Y., & Nomura, S. (2006). Aspirin reduces adverse effects of gefitinib. Anti-Cancer Drugs, 17, 423–427.
To investigate the effects of low-dose aspirin on some adverse effects of gefitinib
Patients were recruited when admitted to the hospital for assessment of lung cancer. For the first two years, patients did not receive aspirin. In 2003, patients were started on aspirin 100 mg/day along with gefitinib treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids were continued in all patients.
Patients were undergoing active antitumor treatment.
The study was a retrospective analysis of treated versus untreated cases.
No instruments or methods were described for toxicity rating.
Overall frequency of EGFRI-related adverse events was 77.8% in those not treated with aspirin and 58.3% in those who received aspirin. Skin rash incidence was 33.3% in those on aspirin and 74.1% of those not on aspirin. There was no apparent difference in gefinitib response between groups.
Findings suggest that aspirin may help to reduce the incidence of some gefinitib toxicities, however, no clear conclusions can be made due to study limitations.
This study aimed to report the effects of low-dose aspirin for prevention of toxicities with gefinitib. The study does not provide strong support for this intervention; however, results suggest that further research in the use of low-dose aspirin could be beneficial.
Kampshoff, C.S., Chinapaw, M.J., Brug, J., Twisk, J.W., Schep, G., Nijziel, M.R., . . . Buffart, L.M. (2015). Randomized controlled trial of the effects of high intensity and low-to-moderate intensity exercise on physical fitness and fatigue in cancer survivors: Results of the Resistance and Endurance Exercise After ChemoTherapy (REACT) study. BMC Medicine, 13, 275-015-0513-2.
To evaluate the effectiveness of a high-intensity (HI) and low-to-moderate–intensity (LMI) resistance and endurance exercise program compared with a wait-list control (WLC) group on physical fitness and fatigue in a mixed group of cancer survivors who completed primary cancer treatment, including chemotherapy
The HI (β = 2.2, 95% confidence interval [CI] [1.2, 3.1]) and LMI (β = 1.3, 95% CI [0.3, 2.3]) groups showed significantly larger improvements in peak VO2 compared to the WLC group. Improvement in peak VO2 was larger for the HI group than the LMI group (β = 0.9, 95% CI [−0.1, 1.9]), but the difference was not statistically significant (p = 0.08). Relative improvements in peak VO2 were 20% and 15% for the HI and LMI groups, respectively, which is in line with the relative improvements in healthy adults after a 12-week exercise program. No significant intervention effects were found for grip strength and 30-second chair-stand tests. Compared to the WLC group, both the HI and LMI groups showed significant improvements in general fatigue (HI: β = −1.3, 95% CI [−2.2, −0.4] and LMI: β = −1.1, 95% CI [−2, −0.2]), physical fatigue (HI: β = −2, 95% CI [−2.9, −1.1] and LMI: β = −1.4, 95% CI [−2.3, −0.5]), and reduced activity (HI: β = −1.1, 95% CI [−1.9, −0.2] and LMI: β = −1.2, 95% CI [−2.1, −0.3]), with no significant differences between both interventions. The HI group showed a beneficial effect on motivation compared to the LMI group (β = −0.8, 95% CI [−1.5, −0.03]) and WLC group (β = −1.2, 95% CI [−1.9, −0.4]), with no significant differences between the LMI and WLC groups. Furthermore, the HI group showed a significant reduction in mental fatigue compared to the WLC group (β = −0.9, 95% CI [−1.7, −0.2]). The effects on peak VO2 were modified by age (HI: βinteraction = −0.2, 95% CI [−0.3, −0.1], p = 0 and LMI: βinteraction = −0.1, 95% CI [−0.2, −0.01], p = 0.03), indicating larger effects for younger participants. No significant interaction effects for gender or diagnosis were found for physical fitness or fatigue.
Supervised HI exercise can be safely recommended to cancer survivors shortly after their completion of cancer treatment. HI and LMI exercise were equally beneficial in counteracting general and physical fatigue.
Advising patients to exercise or referring them to exercise specialists to exercise under supervision is beneficial when possible.
Kampe, S., Wolter, K., Warm, M., Dagtekin, O., Shaheen, S., & Landwehr, S. (2009). Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer. Pharmacology, 84(5), 276–281.
To assess clinical equivalence pain at rest of 20 mg controlled-release oxycodone and 200 mg controlled-release tramadol over 24 hours
Patients were premedicated with midazolam 7.5 mg and continuous-release oxycodone 20 mg or tramadol 200 mg. Patients received the same medication 12 hours later. After surgery, patients had access to rescue medications (paracetamol [acetaminophen]). Postoperative assessments were performed at 8, 16, and 24 hours after premedication.
Randomized double-blinded study
There was no significant difference between treatment groups with regard to adverse effects. The cumulative amount of IV paracetamol given during the first 24 hours after the operation did not differ significantly between the two groups. Postoperative pain management and patient satisfaction were equal in both groups.
There were no significant differences in pain control or incidence of adverse effects between the two groups.
Findings suggest effectiveness of continuous-release tramadol for the treatment of acute pain.
Kamboj, M., Blair, R., Bell, N., Son, C., Huang, Y.T., Dowling, M., . . . Sepkowitz, K. (2015). Use of disinfection cap to reduce central-line–associated bloodstream infection and blood culture contamination among hematology-oncology patients. Infection Control and Hospital Epidemiology, 36, 1401–1408.
To evaluate the impact of the routine use of a passive disinfection cap for catheter hub decontamination
Prior to the use of disinfection caps, the organization followed Centers for Disease Control and Prevention (CDC) recommendations for catheter care and routinely used chlorhexidine-impregnated dressings. The intervention was the routine use of disinfection caps with each central venous catheter (CVC) access rather than manual scrubbing of catheter hubs. The caps were changed after each access or every seven days on high-risk units. After implementation on high-risk units for six months, disinfection caps were introduced for routine use in general oncology units. Central line–associated bloodstream infection (CLABSI) rates were compared across all phases, preimplementation to full implementation. Data were compared to that from clinical units that did not use disinfection caps.
No significant decrease in CLABSI rates occurred when disinfection caps were used in high-risk units. CLABSI rates declined significantly when the caps were introduced among general oncology units that were at high-risk (p < 0.001); however, CLABSI rates did not change significantly within general oncology units that were not high-risk. The proportion of contaminated blood cultures from high-risk units declined after introducing the disinfection caps (p < 0.01). Substantial cost savings with reduction in CLABSI rates and contaminated specimens was estimated, assuming hospitalwide implementation results.
The use of catheter disinfection caps may help reduce CLABSI rates in high-risk patient groups and reduce the contamination of blood culture specimens obtained via catheters.
The findings suggest that the routine use of disinfection caps for CVCs may be helpful in reducing CLABSI rates among patients undergoing hematopoietic cell transplantation (HCT) and those with hematologic malignancies deemed to be at high-risk for infection. This is a relatively low-cost intervention that may be beneficial; however, this study does not provide strong evidence in support of this effect. Given the findings here, further research on the effects of this approach is warranted.
Kamath, J., Feinn, R., & Winokur, A. (2012). Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study. Supportive Care in Cancer, 20, 1745–1753.
To evaluate the efficacy and safety of thyrotropin-releasing hormone (TRH) compared with placebo to treat idiopathic cancer-related fatigue (CRF).
Patients received four study medication bolus infusions, once a week, over a four-week period. The infusions were separated by one week (plus/minus one day). Two of the infusions were TRH at doses of 0.5 and 1.5 mg (lower dose given first), and the other two infusions were placebo. Fatigue assessments were obtained at baseline.
Patients were undergoing the transition phase after active treatment.
The study used a pilot, phase II trial, double-blind, placebo-controlled, crossover design with two randomizations.
Improvements in energy level (p = 0.004 for 0.5 mg TRH and p = 0.002 for 1.5 mg TRH), vigor and fatigue, and sleep disturbance were markedly higher for both TRH doses compared with placebo (saline infusion) throughout the interval from baseline through 72 hours postinfusion. No significant difference existed in energy level between the two doses. The walking test scores and the anxiety and depression symptoms showed no statistically significant difference between TRH and placebo. Side effects included modest increases in blood pressure, heart rate, nausea, flushing, and bladder sensation or urge to urinate.
TRH was safe and well tolerated by the patients. The results suggested significant beneficial effects of intravenous TRH in the treatment of CRF.
More data are needed to confirm these findings with a larger population. Nurses can encourage patients with prominent fatigue symptoms to enter a clinical trial testing the efficacy of TRH.
Kaltenbaugh, D.J., Klem, M.L., Hu, L., Turi, E., Haines, A.J., & Hagerty Lingler, J. (2015). Using web-based interventions to support caregivers of patients with cancer: A systematic review. Oncology Nursing Forum, 42, 156–164.
STUDY PURPOSE: To survey literature focused on social, psychological, financial, technology, and nursing topics for evidence supporting web-based informational and supportive interventions to improve the health of the caregivers of patients with cancer
TYPE OF STUDY: Systematic review
PHASE OF CARE: Early-stage (breast cancer) to stage 4 (lung cancer)
Three of the five articles used in the systematic review showed that web-based interventions decreased caregiver negative mood. One of the three studies showed that a multifaceted CHESS intervention had a moderate effect size (d = 0.387) to decrease caregiver burden and negative mood (d = 0.436) at six months. Another study using CHESS with a clinical report showed small to moderate effect reducing caregiver negative mood at six months and at one year (d = -0.592). A third study describing an informational intervention showed a large effect size (d = 0.88) on this variable. Two multifaceted interventions and one single-faceted intervention supported lower levels of caregiver stress and perceptions of broad social support. Only two of six studies presented usability score outcomes, and only one study addressed the feasibility of the web-based intervention.
Although only six of 581 initial literacy citations met the systematic review study criteria, those six indicated the successful use of web-based cancer caregiver interventions to meet social and psychological needs. The effect sizes of the six studies compared favorably to traditional interventions focused on caregiver burden, self-efficacy, and quality of life. The limited numbers of articles on web-based interventions that positively affected diverse groups of caregivers’ social, financial, and psychological outcomes support future exploration of the usefulness and feasibility of such interventions for cancer caregiver health.
Studies showing significant effects of web-based cancer caregiver interventions may appear more often in the literature to affect article capturing for this systematic review. The lack of identification of caregiver ethnicity in 80% of the cited studies leaves a gap in understanding how non-Caucasian samples or male caregivers may respond to web-based interventions. Published studies after February 1, 2014 were absent from the review. Only six studies met the criteria for the review.
Increasing the use and success of technology to deliver health-related consumer interventions currently support initial evidence for web-based programs, aligned with traditional cancer care, to improve quality of life of patients with cancer and their caregivers. Additional research identify the dosing of Internet interventions and evidence of the efficacy of various forms of interventions is needed.