Pechlivanoglou, P., Le, H.H., Daenen, S., Snowden, J.A., & Postma, M.J. (2014). Mixed treatment comparison of prophylaxis against invasive fungal infections in neutropenic patients receiving therapy for haematological malignancies: A systematic review. The Journal of Antimicrobial Chemotherapy, 69, 1–11.
PHASE OF CARE: Transition phase after active treatment
APPLICATIONS: Elder care
IFI prophylaxis reduces IFI risk but may not affect all-cause mortality. Posaconazole is superior for prophylaxis against IFIs in neutropenic patients; its effectiveness against Aspergillus is more pronounced than against Candida. Fluconazole does not protect against Aspergillus species. Results are consistent with previous studies. The order of antifungal preference matches that recommended by the German Society for Hematology and Oncology. These results were strong, and no severe problems with inconsistency were observed. The original hypothesis that studies with a higher proportion of patients with acute myeloid leukemia (AML) would show a higher risk of acquiring an IFI compared with other types of leukemia was not supported.
Intensive head-to-head comparisons are needed using both chemotherapy populations and HSCT populations. Additionally, institutions should assess the effectiveness of prophylactic options as well as the cost effectiveness of these newer agents.
Payne, C., Wiffen, P. J., & Martin, S. (2012). Interventions for fatigue and weight loss in adults with advanced progressive illness. Cochrane Database of Systematic Reviews, 1, CD008427.
To determine the efficacy of interventions used in the management of fatigue and/or unintentional weight loss in adults with advanced progressive illness by reviewing the evidence contained within Cochrane reviews. This overview does not attempt to rereview the literature or provide information on outcomes not reported within the included Cochrane reviews.
The database searched was Cochrane Database of Systematic Reviews.
No keyword or subject heading was searched because it would be unreliable due to the diverse range of interventions and illnesses under review. The authors hand searched the Cochrane Database of Systematic Reviews by title for all reviews that might assess the effect of an intervention on fatigue and/or unintentional weight loss in adults with advanced progressive illness.
Studies were included if they reported interventions with fatigue and/or unintentional weight loss as the primary treatment intent.
Studies were excluded if the treatment of fatigue and/or unintentional weight loss was not a primary indication for the intervention, they were systematic reviews published outside the Cochrane Library, or if they only included children.
Twenty-seven systematic reviews were retrieved. Assessment of Multiple SysTemAtic Reviews (AMSTAR) was used to assess the methodological quality of each systematic review.
The review looked for the following outcomes:
1. Clinically significant improvements in fatigue and/or unintentional weight loss
2. Improvements in quality of life of people who have fatigue and/or unintentional weight loss
3. Withdrawals due to adverse events.
Results relative to fatigue in patients with cancer included identification of five systematic reviews (116 studies with 17,342 participants).
Nonpharmacologic Interventions
The evidence provided some insight into interventions that may prove beneficial, such as exercise. However, recommendations could not be made for specific exercise interventions that might best manage fatigue. In a systematic review, Cruickshank et al. (2008) reviewed the effect of breast care management strategies on fatigue in women with breast cancer at any stage of their illness. No included study assessed fatigue as an independent outcome, and no conclusions could be drawn. In 2009, Goedendorp reported that for patients undergoing cancer treatment at any disease stage, there was insufficient evidence that psychosocial interventions were beneficial for fatigue management.
Pharmacologic Interventions
Sufficient evidence was not provided for the use of EPA over placebo in patients with advanced cancer. A small but significant improvement with fatigue was found with the use of methylphenidate in 51 studies with 10,296 participants. Use of erythropoietin and darbepoetin showed evidence of an effect over standard of care or placebo for the treatment of cancer-related fatigue. However, increased safety concerns mean they are no longer recommended in practice for this use, especially if the person’s hemoglobin concentration is greater than 12 g/dL. No benefits over placebo were seen for fatigue with the use of antidepressant drug paroxetine, nor with progestational steroids.
There was a lack of robust evidence for interventions for fatigue management in the advanced stage of progressive illness related to cancer.
Extraction of data was limited to Cochrane reviews. Fatigue as an outcome indicator was not always sufficiently reported.
Exercise interventions can lead to an improvement in fatigue in patients with cancer; however, this beneficial effect requires further research for those in the advanced stage.
Payne, J. K., Held, J., Thorpe, J., & Shaw, H. (2008). Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncology Nursing Forum, 35, 635–642.
To determine if a home-based walking program is more effective than usual care in reducing fatigue, sleep disturbances, and symptoms of depression in older women receiving hormone treatment for breast cancer.
Patients were recruited from breast cancer clinics and randomized to usual care or a prescribed exercise program that focused on walking. Researchers followed patients' progress over a 14-week period. Patients completed study instruments at baseline, two weeks later via mail, 12 weeks after baseline at a clinic visit, and 14 weeks after baseline via mail. Cortisol, serotonin, interleukin-6 (IL-6), and bilirubin were collected at the initial clinic visit and again at three months. At visit 1 and at 12 weeks, patients were asked to wear a sleep-watch actigraph for 72 continuous hours. The walking exercise intervention was a moderate walking activity for 20 minutes, four times a week. Patients were to log the duration and frequency of walking activity.
The study was a longitudinal, repeated-measures, randomized, clinical trial.
Levels of fatigue over time and between groups were not significantly different. PSQI scores decreased significantly over time in the exercise group (p = 0.007) and did not change in the usual care control. Actigraphy analysis after 12 weeks showed a shorter wake time (p = 0.02), sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group. There was no difference between groups in regard to sleep efficiency, which is the ratio of total sleep time to time in bed. There were no differences in cortisol levels over time or between groups. ANOVA showed a significant difference between groups and across time in serotonin levels, with an intervention effect of exercise (p = 0.009). There were no differences between groups or over time in regard to symptoms of depression.
A home-based walking intervention appears to be acceptable to older women receiving hormone therapy for breast cancer and an intervention that is feasible for use in that population. Decline in PSQI scores in the exercise group suggest that this type of intervention may help improve sleep quality in this population. Effects of the exercise intervention on biomarkers are unclear.
An exercise program involving walking may be helpful to patients receiving hormone treatment for breast cancer, but the actual effects of such a program on fatigue, sleep, and symptoms of depression are unclear.
Payne, J. K., Held, J., Thorpe, J., & Shaw, H. (2008). Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncology Nursing Forum, 35, 635–642.
The primary aim was to determine if a home-based walking exercise program is more effective than usual care in reducing fatigue, sleep disturbances, and depressive symptoms in older women receiving hormonal treatment for breast cancer as a feasibility study. The secondary aim was to examine the extent to which symptoms and biomarkers of cortisol, serotonin, interleukin-6 (IL-6), and bilirubin are related and change over time.
Participants were recruited from breast cancer clinics and randomized to usual care or a prescribed walking exercise program. Participants were followed over a 14-week period. At an initial clinic visit, demographic data were collected and participants completed study instruments. Study instruments were again completed two weeks later via mail, 12 weeks after baseline at a clinic visit, and at 14 weeks via mail. Cortisol, serotonin, IL-6, and bilirubin were collected at the initial clinic visit and at 3 months. Blood samples were carefully handled to ensure appropriate handling for radioimmunoassay and other laboratory testing. At visit 1 and at 12 weeks, patients were asked to wear a sleep watch actigraph for 72 continuous hours. A study coordinator or investigator explained the walking exercise intervention, which was a moderate walking activity for 20 minutes, four times a week. Participants in the exercise group were shown how to use a pedometer that was provided to them but were not required to use it. Participants were given a log to record the duration and frequency of walking activity.
Participants were included if they
Individuals were excluded if they had a history of neurologic deficits or mental illness in the past year or had neuromuscular deficits that would contraindicate use of a walking program.
This was a longitudinal, repeated measures, randomized, clinical trial.
Levels of fatigue over time and between groups were not significantly different. PSQI scores decreased significantly over time in the exercise group (p = 0.007) and did not change in the usual care controls. Actigraphy analysis after 12 weeks showed a shorter wake time (p = 0.02), sleep time (p = 0.05), and less movement during sleep (p = 0.002) in the exercise group. There was no difference between groups in sleep efficiency, the ratio of total sleep time while in bed. There were no differences in cortisol levels over time or between groups. ANOVA showed a significant difference between groups and across time in serotonin levels, with an intervention effect of exercise (p = 0.009). Serotonin levels were correlated with actual wake time, but correlations were not statistically significant. There were no significant differences in IL-6 or bilirubin between groups or over time. Bilirubin levels in both groups were at or above the upper limit of normal range. Correlation analysis for cortisol, IL-6, and bilirubin were not reported. There were no differences between groups or over time in depressive symptoms. Actual patient adherence to prescribed exercise was not reported. Authors reported that the walking exercise intervention was accepted in this population.
Home-based walking intervention appears to be feasible and acceptable to older women receiving hormonal therapy for breast cancer. The decline in PSQI scores in the exercise group suggests that this type of intervention may be helpful in improving sleep quality in this population. Effects of the exercise intervention on biomarkers are unclear. There was no observed effect of the exercise intervention on fatigue.
A walking exercise program may be helpful to patients receiving hormonal treatment for breast cancer, but actual effects on fatigue, sleep, and depressive symptoms are unclear.
Pawar, D., Neve, R. S., Kalgane, S., Riva, A., Bombardelli, E., Ronchi, M., et al. (2012). SAMITAL((R)) improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer.
Investigate the safety and efficacy of SAMITAL in the treatment of oral mucoitis with chemo-radiation therapy.
Patients received either Samital or a matching placebo mouth rinse. Patients were blinded to which treatment they had. Random assignment was not described. Samital is a combination of three botanical drug extracts: vaccinium myrtillus, macleaya cordad, and Echinacea angustifolial root. The formulation is standardized, and forms a gel-like substance when re-constituted. Patients were to use the rinse 4 times daily for a total of 7 weeks. Each rinse was done using 4 aliquots over 30 minutes.
The study was comprised of 17 patients, with a mean age of 52.4 years.
MALES 89%, FEMALES 11%
KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving chemo-radiation. All had oral mucositis ≥ grade 3 on study entry, and 30% had cancer of the tongue.
SITE: Single site
SETTING TYPE: Outpatient
LOCATION: India
PHASE OF CARE: Active antitumor treatment
Single, blind, placebo controlled phase II
None of the control group patients completed the study; most only completed seven days. Patients on SAMITAL showed significant improvement from baseline in mucositis grade from 2.94 ± 0.43 to 2.0 ± 0.35, drinking, eating, sleeping, and speaking (p < 0.05) after day 31. Those in the placebo group did not show significant changes from baseline.
Findings suggest that SAMITAL might have some benefit in management of oral mucositis; however, this study has substantial limitations and does not provide strong evidence.
This study examined use of SAMITAL, a botantical preparation, for its efficacy in management of oral mucositis. Some positive effects are described; however, this study does not provide strong evidence. Further well-designed research in this area may be warranted.
Paulsen, O., Aass, N., Kaasa, S., & Dale, O. (2013). Do corticosteroids provide analgesic effects in cancer patients? A systematic literature review. Journal of Pain and Symptom Management, 46, 96–105.
STUDY PURPOSE: To assess the evidence for use of corticosteroids as adjuvant analgesics in patients with cancer pain
TYPE OF STUDY: Systematic review
DATABASES USED: PubMed, EMBASE, Cochrane Collaboration, Cochrane Central Register of Controlled Trials
KEYWORDS: Specific search terms for PubMed are provided.
INCLUSION CRITERIA: RCT; adult patients with cancer; compared corticosteroids when added to standard pain treatment; assessed outcomes in pain, analgesic use, and adverse events
EXCLUSION CRITERIA: Non-English language
TOTAL REFERENCES RETRIEVED = 514
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Grading of Recommendations Assessment, Development and Evaluation; overall study quality in terms of risk of bias was low.
Of the four studies included, one showed lower pain severity and analgesic consumption with steroid, two had unclear results because of lack of findings reported, and one showed no benefit.
The evidence regarding efficacy of adjuvant corticosteroids for pain management in patients with cancer is insufficient to draw firm conclusions. No current evidence is strong enough to show efficacy, and information is limited about adverse events with any long-term use.
Evidence is insufficient to demonstrate benefit from the addition of corticosteroids to usual pain management in patients with cancer, and evidence is very limited regarding adverse effects in this setting. Studies only have been reported with short-term use, so long-term adverse effects are not clearly known.
Paulsen, O., Klepstad, P., Rosland, J.H., Aass, N., Albert, E., Fayers, P., & Kaasa, S. (2014). Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial. Journal of Clinical Oncology. Advance online publication.
To compare the analgesic efficacy of corticosteroid therapy versus a placebo
The intervention was methylprednisolone 32 mg daily for seven days. The research team used a computerized randomization program to assign participants to intervention or placebo groups. Randomization stratification was based on study center and verified pain related to bone metastases. Both the research team and study participants were blinded to study assignment. Pain intensity, fatigue, and appetite loss were measured at baseline and day 7. Analgesic use was recorded daily. Satisfaction with the intervention was measured at day 7. Semistructured interviews were conducted at day 7 to determine any adverse effects experienced by study participants.
Placebo-controlled, double-blind, randomized controlled trial
No significant difference was found between groups for average pain intensity at day 7, change in pain intensity from baseline, opioid intake, or adverse events. However, the intervention group did have a significant improvement in fatigue (p = .003) and appetite (p = .003) at day 7 compared to the placebo group. In addition, their overall satisfaction with treatment was also significantly greater (p = .001).
Pain relief was not improved for patients with advanced cancer who were taking on average a 222 mg oral morphine equivalent dose (MED). It is unknown whether this may be effective for different patient populations such as those taking a lower MED. Improvement in fatigue and appetite and a low number of adverse events were important clinical outcomes. Further study is needed to determine the long-term effects of this intervention.
Nurses should be aware that methylprednisolone 32 mg daily may not be effective for improving pain relief in patients with advanced cancer who are taking an average opioid dose of ≥ 220 MED; however, it may improve fatigue and appetite with minimal adverse effects. Long-term effects have not yet been established. Long-term steroid use can contribute to other adverse side effects and should be weighed carefully with benefit of treatment.
Paul, S., Saxena, A., Terrin, N., Viveiros, K., Balk, E.M., & Wong, J.B. (2016). Hepatitis B virus reactivation and prophylaxis during solid tumor chemotherapy: A systematic review and meta-analysis. Annals of Internal Medicine, 164, 30–40.
STUDY PURPOSE: To determine the risk of hepatitis B virus (HBV) reactivation with or without antiviral prophylaxis, and the effectiveness of prophylaxis
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
Risk for HBV reactivation without prophylaxis ranged from 4%–68% (median = 25%) and with prophylaxis ranged from 0.9%–31.4% (median = 4.1%). Among 13 studies comparing reactivation risk between patients who did and did not receive HBV prophylaxis, the pooled odds ratio [OR] was 0.12 (95% confidence interval [CI] [0.06, 0.22]).
HBV prophylaxis can help reduce the odds of HBV reactivation in patients with solid tumors undergoing chemotherapy.
HBV prophylaxis may reduce the chance of patients with a history of HBV experiencing reactivation when undergoing chemotherapy for solid tumors. The authors of this article noted that guidelines regarding HBV screening vary. While the American Society of Clinical Oncology (ASCO) recommends screening for individuals at high risk, the Centers for Disease Control and Prevention (CDC) and others recommend screening all patients receiving immunosuppressive therapy. The findings here provide some support for broad HBV screening and the appropriate use of HBV prophylaxis; however, this analysis had multiple limitations. Further study is warranted to determine the screening, prophylaxis, and cost-effectiveness benefits of these actions.
Paul, M., Ram, R., Kugler, E., Farbman, L., Peck, A., Leibovici, L., . . . Raanani, P. (2014). Subcutaneous versus intravenous granulocyte colony stimulating factor for the treatment of neutropenia in hospitalized hemato-oncological patients: Randomized controlled trial. American Journal of Hematology, 89, 243–248.
To examine the effectiveness of intravenous (IV) versus subcutaneous (SC) granulocyte colony-stimulating factor (G-CSF) as related to time to neutropenia resolution and secondarily to assess comparative rates of infection, adverse effects, and patient satisfaction
Randomized, controlled, open-label trial with a 1:1 randomization to SC versus IV filgrastim. Patients were given either IV or SC filgrastim on a prescribed day (day 7 of chemotherapy for patients with acute myeloid leukemia [AML], day 2 after completion of chemotherapy for lymphoma and myeloma, and the day after infusion for patients undergoing hematopoietic stem cell transplantation [HSCT]). On the subsequent chemotherapy course (at least 30 days later), patients were crossed over to the alternative study arm.
Randomized, controlled, open-label trial
Time to neutrophil resolution was longer with an IV bolus G-CSF compared to SC G-CSF with an overall mean difference of 2.5 days. There were no differences in clinical outcomes, including infection rates or adverse events observed.
The trial was not powered to examine possible serious complications of SC G-CSF administration and was stopped prematurely due to the observed results.
Findings support the continued use of SC G-CSF for limiting the duration of neutropenia. Education about the use of G-CSF in the prevention of neutropenia and managing related side effects is important.
Patel, M., Schimpf, M.O., O'Sullivan, D.M., & LaSala, C.A. (2010). The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: A randomized, double-blind, placebo-controlled trial. American Journal of Obstetrics and Gynecology, 202, 479.e1–479.e5.
To compare the time of first bowel movement (BM) following pelvic reconstructive surgery in patients randomized to placebo or senna with docusate.
Patients were enrolled prior to surgery. After surgery, patients were randomized to either senna with docusate or placebo. Dosing was as follows.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blinded, placebo-controlled trial.
The use of a stool softener with a laxative such as senna with docusate decreases the time to first BM following pelvic reconstructive surgery compared with placebo and lessens the need for use of magnesium citrate.
Nurses should be proactive in the management of patients' bowels following reconstructive surgery. Management with medications such as senna with docusate may be an option for patients following this form of surgery.