To review the current published research from randomized controlled trials (RCTs) and crossover trials evaluating the efficacy of ginger for prevention of chemotherapy-induced nausea and vomiting (CINV)

Databases searched were PubMed, CINAHL, and Cochrane library.

Search keywords were ginger, cancer , chemotherapy, nausea, emesis, vomiting, and CINV.

Studies were included in the review if they

• Were RCTs or crossover trials.
• Involved ginger as the main intervention.
• Were in English language.

Study exclusions were not reported.

• A total of 27 references were initially retrieved.
• Studies were rated using the National Health and Medical Research Council hierarchy of evidence. 
• The overall body of evidence was rated according to the American Dietetic Association quality criteria checklist.

• Seven studies were included in the final review.
• Sample sizes ranged from 36-576 patients in each trial for a total of 1,013 patients across all studies.
• One study was of children. Samples included male and female participants.

• All patients were in active antitumor treatment.
• The report has applications for pediatrics.

• Four studies reported positive results with ginger, and three showed no benefit. 
• Varied ginger doses were used, and various comparisons were used.
• Only one study involved use of a 5-HT₃ or other recommended CINV treatment in the regimen. 
• All studies were rated as level II (with level I as the highest level); however, not all studies reported how CINV was measured, and one involved multiple emetogenicity levels.

At best, findings show mixed results for use of ginger.  Overall body of evidence was rated as “C’ in which “D” was the lowest possible level.

• The number of studies was limited.
• The quality rating method used was questionable, because all studies were highly rated for quality but some did not even define the method of CINV measurement. 
• The review did not take into account what treatments were used for control comparisons, and many did not include recommended treatments.

This review does not support the use of ginger for CINV prevention.

To compare the safety and efficacy of fosaprepitant with the safety and efficacy of aprepitant

Patients on cisplatin-based chemotherapy were randomly assigned to receive a single IV dose of fosaprepitant or a three-day dosing regimen of aprepitant. All also were given a dexamethasone regimen and ondansetron on day 1. Both groups could receive rescue therapy. Patients recorded nausea and vomiting episodes for the first 120 hours after chemotherapy.

• N = 272
• MEAN AGE =  50.5 years
• AGE RANGE = 19–79 years
• MALES: 73.5%, FEMALES: 24.5%
• KEY DISEASE CHARACTERISTICS: Patients had varied tumor types; lung and gastrointestinal cancers were most prevalent.

• SITE: Multi-site  
• LOCATION: India 

• PHASE OF CARE: Active antitumor treatment

• Subgroup analysis of a double-blind, randomized controlled trial

• Patient diary

No significant differences occurred between groups in complete response (CR) during the acute phase. In the delayed phase, 77.7% of patients on fosaprepitant had CR compared to 73.9% in the aprepitant group. This difference was not statistically significant. No differences existed in need for rescue medication. None of the patients experienced infusion site reactions with fosaprepitant.

The findings showed essentially equivalent efficacy of single dose fosaprepitant and a three-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) with highly emetogenic chemotherapy.

• Risk of bias (no blinding)
• The study states a double-blind design and refers to a placebo, but the use of a placebo is not described in the report.

A single dose of fosaprepitant can provide the same essential prevention of CINV as a multiday aprepitant regimen as part of triple-drug therapy. Infusion site reactions have been described with fosaprepitant but were not shown in this particular analysis. Selection of the type of NK₁ use can be planned according to individual patient situations.

MEDLINE, PsycInfo, CancerLit, CINAHL, American College of Physicians Journal Club, Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effectiveness were searched using key words in groups (a) patient, ill, illness or health, (b) family, caregiver, caregiving, marriage, marital, spouse, spousal, couple, or partner, and (c) treatment, intervention, or support. ERIC, Social Work Abstracts, Expanded Academic ASAP, Academic Search Elite, PubMed, ISI Web of Knowledge and Web of Science, Economic and Social Research Council, Inter-University Consortium for Political and Social Research, and Physician Data Query/National Cancer Institute, as well as tables of contents of all Elsevier Publications medical journals, were searched using the key words family, caregiving or caregiver, and intervention or treatment.

• Seventy randomized trials comparing interventions with usual care were used.
• The sample was a mixture of family caregivers of individuals with chronic illness (Alzheimer disease, dementia, stroke, cardiac disease, chronic pain, rheumatoid arthritis, brain injury, and cancer).
• The sample included two large studies of 2,042 (Alzheimer) and 4,408 (post-myocardial infarction) participants.
• Excluding those two large studies, the average sample size was 87 caregivers.

Overall, evidence suggested that interventions reduced depressive symptoms in family members when the intervention focused on illnesses other than dementia. Family interventions targeted to patients and family members (as a dyad) or to family members alone were effective in reducing caregiver burden. Interventions offered to spouses alone or to a combination of family members were effective in reducing caregiver burden. Interventions had a stronger effect in reducing burden, depression, and anxiety when relationship issues between patients and caregivers were addressed.

No evidence was found that psychosocial interventions relieved anxiety in family members (uniform across studies).

A family intervention demonstrated the strongest evidence for improving family burden and was uniform across studies for spouses and for mixed groups of family members.

Only five studies included cancer populations.

To determine the effectiveness of manual lymph drainage (MLD) in reducing lymphedema in patients with breast cancer

Participants were randomly assigned to a control group and an experimental group. The control group received standard lymphedema treatment as well as a month of ambulatory treatment, daily bandaging from hand to shoulder for the first four weeks (removed at night), compression garments, and patient education regarding prevention guidelines and exercises to perform at home. The experimental group received the standard treatment plus MLD. MLD was performed before the bandaging occurred.

• The study sample (N = 58) was comprised of White female patients with breast cancer who had ipsilateral axillary lymphedema.
• Al patients
  • Had prior mastectomy, tumerectomy, or quadrantectomy and axillary lymphadenectomy
  • Finished radiotherapy or chemotherapy six months prior to study
  • Did not have rehab within three months prior to recruitment.

The study took place at a rehabilitation facility in Brazil.

Patients were undergoing active lymphedema treatment.

The study used a randomized controlled trial design.

• The measurement used to determine the effectiveness of MLD was the percentage of volume reduction after treatment using the water-displacement method.
• The investigators defined a good response to treatment as a 20% or more reduction in volume of the effected extremity.
• Measurements were taken at baseline and one, three, and six months.
• Patients also took a quality-of-life questionnaire for cancer in general and for breast cancer.

At 12 months the incidence of lymphedema in the intervention group was very similar to the control group: 24% and 19%, respectively. This difference is not considered statistically significant. There were no incidence differences at three and six months. There was also no difference in the time taken to develop lymphedema, secondary outcome measures of arm circumference, health-related quality of life, and patient reports.

Because of the lack of statistically significant changes in lymphedema incidence between control and intervention groups, it can be concluded that MLD is not effective in preventing lymphedema in the first year post-operatively in patients with breast cancer.

The study had a small sample size, with less than 100 participants.

The study indicates that MLD does not provide a statistically significant improvement in limb volume in patients with lymphedema. One of the greatest limitations of the study is the sample size. If the results of a repeated randomized controlled trial with a larger sample size yields similar results, MLD should not be taught to lymphedema patients because studies suggest it is unnecessary and ineffective.

Databases searched were MEDLINE (1966–2005), EMBASE (1974–2005), Cochrane Central Register of Controlled Trials (issue 2, 2005), and specialized registers of the Cochrane Cancer Network and the Cochrane Pain, Palliative and Supportive Care Group. Also searched were metaRegister of Controlled Trials, U.S. National Institutes of Health register, register of the Center for Clinical Trials and Evidence-Based Healthcare, and register of the European Organization for Research and Treatment of Cancer.

Registers of trials in progress also were assessed.

Studies were included in the review if they

• Reported on calcitonin plus a rescue medication versus placebo plus a rescue medication
• Used any comparison between different models and intervention doses of interest
• Included use of steroids or analgesic radiotherapy if administration was equal in each treatment arm.

Studies where bisphosphonates were administered before patients were randomized to different treatment arms and studies where the efficacy of calcitonin in treating pain was measured over a short period (less than four weeks) were excluded.

The review included two randomized, double-blind clinical trials of patients with metastatic bone pain for a total of 90 patients. The first study compared calcitonin (100 IU administered subcutaneously each day for 28 days) versus placebo administered to a group of 40 women with breast cancer and pain from bone metastasis. The second study compared calcitonin (100 IU administered subcutaneously each day for three months) versus placebo in 50 women with breast cancer and painful bone metastases.

Of the two studies selected (90 patients), all patients had metastatic bone pain caused by any primary tumor, diagnosed by computed tomography, bone gammagraphy, nuclear magnetic resonance, or other radiographic process.

The limited available evidence does not support the use of calcitonin to control pain from bone metastases.

Calcitonin has been assessed in studies with small sample sizes and too short-term evaluations.

More double-blind, parallel clinical trials using long-term evaluations are needed.

STUDY PURPOSE: To evaluate the effectiveness of healthcare interventions targeting pain in patients with cancer

TYPE OF STUDY: Systematic review

DATABASES USED: PubMed, CINAHL, PsycINFO, DARE, and Cochrane Collaboration; reference lists were used to identify additional studies.

KEYWORDS: Search terms and strategy specifics are in an online appendix to this article.

INCLUSION CRITERIA: Random or nonrandom trials with a control group. Patient-centered and institutional change interventions were included in the definition of healthcare interventions. Pain was included as an outcome.

EXCLUSION CRITERIA: Not specified

TOTAL REFERENCES RETRIEVED = 1,3014

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: GRADE system of quality evaluation; risk of bias was high in seven studies and moderate in another seven studies.

• FINAL NUMBER STUDIES INCLUDED = 19 
• TOTAL PATIENTS INCLUDED IN REVIEW = 97
• KEY SAMPLE CHARACTERISTICS: Mixed tumor types; median follow-up was 8 weeks (range was 2–24 weeks); all had advanced cancer.

APPLICATIONS: Palliative care

Of the studies, 89% examined patient educational activities. Two focused on provider-level interventions. Fifty-five percent of studies (11 studies) that measured knowledge and barriers found significant improvement in barriers to pain management. Five studies measured pain knowledge–two of these showed improvement. Forty-seven percent of the 19 studies showed significant improvement in pain outcomes compared to the control group. Findings varied by the type of intervention used, and results suggest that the use of multiple educational modalities may be more effective. The number of patient encounters in studies varied widely.

Psychoeducational interventions significantly can reduce barriers to pain management, improve pain knowledge, and improve pain outcomes.

• Many studies had small sample sizes and moderate to high risk of bias. 
• The samples had little ethnic diversity. 
• Although most used the Brief Pain Inventory, studies used different components of the tool and individual subscales only.

Psychoeducational interventions can reduce patient barriers to pain management, improve relevant knowledge, and have a positive impact on pain. Multimodal interventions combining various educational media and follow-up appear to be more effective than alternatives. Data are limited to show effects of institutional, provider-focused interventions, but results in this area are promising. A combination of provider- and patient-focused interventions should be evaluated.

To use a bundle approach to reduce central line–associated bloodstream infections (CLABSI) in patients with hematologic malignancies and neutropenia with long-term central venous catheters (CVC)

Between 2010 and 2012, a bundle of interventions was introduced and outcomes were compared with the results from six months prior to the intervention. Interventions were the use of a different catheter (a neutral pressure mechanical valve connector versus a positive pressure mechanical valve connector), changing needless connectors twice weekly instead of weekly, and the replacement of a chlorhexidine solution to clean needless connectors rather than a solution with 70% alcohol. If blood cultures were obtained, patients were put on broad spectrum antibiotics. All patients were receiving prophylactic co-trimoxazole, itraconazole, and environmental neutropenic precautions.

• N = 116   
• AGE = older than 18 years
• MALES: Not provided  
• FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: Patients with acute leukemia, multiple myeloma, or non-Hodgkin lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: All had tunneled catheters

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Portugal

• PHASE OF CARE: Active antitumor treatment

• Prospective with historical cohort comparison

Blood cultures were obtained for the presence of a fever for more than one hour or other signs of infection from peripheral veins and CVC lines.

With the intervention, a 71% reduction in both CLABSIs (risk ratio [RR] = 0.29, p < 0.014) and overall bloodstream infections (RR = 0.28, p < 0.001) occurred. The reduction of gram-positive bacteria was most pronounced.

The institutional protocol changes related to catheter selection and IV access system care were associated with a reduction in CLABSIs.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Limited sample description.
• Outcomes measured at 72 hours only
• No information was provided regarding other aspects of care or techniques used in insertion.

The changes implemented here were associated with the reduced incidence of CLABSIs within 72 hours. The authors suggested that changing from a positive pressure valve catheter to a neutral pressure type catheter may have been most relevant, as positive pressure valves tend to develop a biofilm and cannot be cleaned well with routine flushing.

STUDY PURPOSE: To assess safety and efficacy of interventions used to prevent blood loss during treatment of cervical intraepithelial neoplasia (CIN)

TYPE OF STUDY: Meta-analysis and systematic review

PHASE OF CARE: Active antitumor treatment

• Vasopressin versus placebo: One trial showed significant reduction in blood loss (MD -100.9, p < 0.00001). One trial examined selective bleeding and showed a significant reduction with vasopressin (RR = 0.4, p < 0.0001)
• Tranexamic acid (TA) versus placebo: One trial showed reduction in postoperative blood loss with TA (MD -55.6, p < 0.0001). Analysis of two trials showed no meaningful difference in the risk of primary hemorrhage (RR = 1.24), and across four trials, there was significantly reduced risk of secondary hemorrhage with TA (RR = 0.23, p = 0.00017).
• Vaginal pack with Monsel’s solution: Vaginal packs were associated with significant reduction in perioperative blood loss and decreased risk of dysmennorhea compared with hemostatic sutures (p < 0.05).

Vasopressin, TA, and vaginal packs with Monsel’s solution appear to be helpful in reducing blood loss in women with CIN undergoing surgical procedures. Findings are limited because few studies exist comparing specific interventions.

• Limited number of studies included
• Mostly low quality/high risk of bias studies

This review contains limited evidence; however, findings suggest that use of vasopressin, TA, and vaginal packs with Monsel’s solution may be helpful to reduce various types of procedure-related bleeding in women with CIN.

To evaluate the effects of a six-week yoga intervention on caregivers’ overall quality of life and psychological distress

Caregivers participated in a particular type of yoga called vinyasa yoga (VY) for 150 minutes per week, which was conducted in two 75-minute sessions for six weeks. Each VY session included breathing exercises, meditation, poses, and a particular subtype of VY called savasana that promotes relaxation and relieves stress.

• N = 12
• AGE = 18–65 years
• MALES: 8%, FEMALES: 92%
• KEY DISEASE CHARACTERISTICS: Participants were the informal, unpaid caregivers of patients with cancer. No information is provided about the type of cancer. 
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers who reported a level of distress that was disrupting their lives based on the National Comprehensive Cancer Center Distress Thermometer were included in the study. 

• SITE: Single site  
• SETTING TYPE: Other  
• LOCATION: Dalhousie University public recreational facility, Canada

• PHASE OF CARE: Multiple phases of care

• A single-group, pre- and post-test pilot study

• Profile of Mood States (POMS)
• TMD = total mood disturbance or overall psychological distress
• SF-36, version 2 to measure quality of life

The overall attendance rate was 65%. Participants had a mean baseline distress score of 6.5 out of 10. A significant difference was seen in TMD scores from baseline to post-intervention (p = 0.002). Although no significant difference was seen in the physical component score of SF-36 from baseline to post-intervention, a significant difference was seen in the mental component scores of SF-36 from baseline to post-intervention (p = 0.018). The effect in the intended outcome for TMD scores and MCS was large.

Cancer caregivers may benefit mentally with reduction in psychological distress from VY.

• Small sample (less than 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias(sample characteristics)
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: Although this study shows some positive findings, including reduction in psychological distress and improvement in the mental component of quality of life, small sample size and the absence of a control group reduce the strength of this study. Also, the majority of the participants were women, which reduces the generalization of the findings to both genders. Details regarding who conducted the yoga teaching and whether they are trained in yoga are not provided in the study.

VY seems to be a cost-effective approach to improve the quality of life and psychological distress in cancer caregivers. Nurses can encourage caregivers to participate in VY programs. RCTs with larger sample size are needed to find the true effect of yoga on cancer caregivers in terms of reducing psychological distress and improving quality of life.

To describe the effect of denosumab on pain and analgesic use in patients with giant cell tumor of bone (GCTB)

Patients were split into two groups, cohort 1, which contained patients with unresectable disease or multiple lesions, and cohort 2, which contained patients with resectable disease but for whom surgery was associated with high morbidity. Patients received denosumab every four weeks with additional doses on days 8 and 15. Pain was assessed with the Brief Pain Inventory Short Form at baseline and each visit for the first six months and every three months thereafter.

• N = 271  
• AVERAGE AGE: 33.5 years
• MALES: 41%, FEMALES: 59%
• KEY DISEASE CHARACTERISTICS: Patients had either unresectable disease or had disease associated with high morbidity; ≥ 12 years old with active histologically confirmed GCTB

• SITE: Multi-site  
• SETTING TYPE: Not specified    
• LOCATION: Multiple international centers

• PHASE OF CARE: Mutliple phases of care
• APPLICATIONS: Elder care and palliative care 

• Phase II, prospective clinical trial

• The Brief Pain Inventory Short Form (BPI-SF) was used to evaluate pain and minimally important differences.
• The Analgesic Quantification Algorithm (AQA) was used to evaluate analgesic use at each visit.

Denosumab is a reasonable treatment choice for pain relief in patients with GCTB with unresectable disease, disease with multiple lesions, or for patients in whom resection would be associated with high morbidity. This treatment would reduce radiotherapy-related risks and provide a medical option for treating patients in who  surgical intervention (the treatment of choice) is not a option or is presented as a high-risk option.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Denosumab is an easy drug to administer that has few side effects. Education on the drug and its administration would be required to effectively treat patients limited to this option. Nurses could help advocate for patients with unresectable disease or disease associated with high morbidity with surgery. This could be an alternative to radiation if patients are unable to receive radiation or are concerned about the low but present risk of secondary tumors from radiation treatment.