Lee, S. (2015). Mineral derivatives in alleviating oral mucositis during cancer therapy: A systematic review. PeerJ, 3, e765.
TOTAL REFERENCES RETRIEVED: 1,027
PHASE OF CARE: Multiple phases of care
Outcome mineral derivatives included zinc (n = 549, seven studies), calcium phosphate (n = 227, three studies), povidone-iodine (n = 228, two studies), and selenium (n = 116, two studies). The severity of OM was measured across variable OM grading systems. In 13 studies, individuals in treatment groups (n = 958) experienced peak OM less than controls (g = −0.47,95% CI −0.7 to −0.2, p = 0.0006). In five studies, time to OM onset was significantly delayed in treatment versus controls (g = −0.51, 95% CI−0.8 to −0.2, p = 0.0002), but the mean duration of OM, pain incidence, and analgesic use was not significantly different.
The general positive effect trend suggested that individuals taking mineral derivatives during cancer therapies were less likely to experience peak OM. However, the significant bias and heterogeneity in this analysis indicated the need for additional methods because of diverse protocols and novel recordings (serum mineral levels and cell signals) in estimating a uniform true effect. The decision analysis favored selenium.
This review was limited in recommending a definitive mineral derivative to alleviate OM. Limitations included high heterogeneity implicated by variable conditions (i.e., different protocols, diverse cancer therapies). In addition, a placebo effect may have undermined nonblinded studies at a high risk of bias.
Future trials should consider serum levels and computer simulations when designing mineral tolerance thresholds to weigh benefits and harms.
Lee, K.H., Kim, J.Y., Lee, M.H., Han, H.S., Lim, J.H., Park, K.U., . . . Im, S.A. (2015). A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09. Supportive Care in Cancer, 24, 1709–1717.
To identify an optimal dose of GCPGC and compare its safety and efficacy to that of pegfilgrastim
This study involved two phases—a phase II trial to identify optimal dosage followed by a phase III study to determine efficacy and safety of GCPGC in comparison to standard pegfilgrastim. In phase II, patients were randomized to receive either 3.6 mg or 6 mg of GCPGC on day 2 of a cycle. There were no differences in neutropenic outcomes between groups, and researchers decided to use 6 mg for phase III. In phase III, patients were randomized to receive either 6 mg pegfilgrastim or 6 mg GCPGC on day 2 of their treatment cycle. Outcomes per treatment cycle were evaluated. During phase III, prophylactic antibiotics were not permitted in the first cycle but could be used in subsequent cycles according to physician discretion.
There were no significant differences in outcomes between groups other than time to ANC recovery. ANC recovery time after cycle 1 was a mean of 8.85 in the GCPGC group compared to 9.83 in the pegfilgrastim group (p < 0.0001). Incidence of treatment delay or dose reduction was higher in the pegfilgrastim group (p < 0.09). Adverse drug reactions that may have been associated with the study drug were 5.3% in the GCPGC group and 3.4% in the pegfilgrastim group, and included dizziness, eukocytosis, blurred vision, injection-site pain, pyrexia, headache, and peripheral sensory neuropathy.
GCPGC was not inferior to pegfilgrastim for prevention of febrile neutropenic complications in women receiving myelosuppressive chemotherapy. Additional research is needed to confirm its efficacy and safety.
GCPGC provided similar results as pegfilgrastim in terms of neutropeni- related complications with this type of myelosuppressive chemotherapy. However, adverse events appeared to be somewhat higher in the GCPGC group. Additional research is needed to confirm the safety profile of this new CSF.
Lee, S., Knox, A., Zeng, I.S., Coomarasamy, C., Blacklock, H., & Issa, S. (2013). Primary prophylaxis with granulocyte colony-stimulating factor (GCSF) reduces the incidence of febrile neutropenia in patients with non-Hodgkin lymphoma (NHL) receiving CHOP chemotherapy treatment without adversely affecting their quality of life: Cost-benefit and quality of life analysis. Supportive Care in Cancer, 21, 841–846.
To examine the cost-benefit of primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) in patients with non-Hodgkin lymphoma (NHL) receiving cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) chemotherapy
In 2007, the study site implemented standard primary prophylaxis with G-CSF in this group of patients. Outcomes were compared to a historical control group that had not received primary prophylaxis. Analysis of cost was based on institutional direct costs for treatment of febrile neutropenia (FN).
Patients who received primary G-CSF prophylaxis were compared to a group of patients who did not receive primary prophylaxis prior to 2007, when primary prophylaxis was instituted as the standard of care for these patients. Among those who received prophylaxis, the incidence of FN was 5%, compared to 60% of those who had not received prophylaxis (p < .0001). Cost-benefit analysis using the number needed to treat and the average cost of an FN episode showed that prophylaxis increased the cost by $238 (New Zealand dollars), including only direct costs.
Primary G-CSF prophylaxis was associated with a significant reduction in the incidence of FN for a small additional cost of overall care throughout CHOP chemotherapy.
Primary G-CSF prophylaxis was associated with significantly lower prevalence of FN. Based only on direct healthcare costs, this study showed that primary prophylaxis was associated with a small, incremental increased cost, but these data do not account for other indirect costs and the full range of healthcare utilization that may be associated with treatment of FN. The authors concluded that primary prophylaxis in this group of patients was cost-effective. The cost-benefit of primary G-CSF prophylaxis has been a recent area of interest in oncology care. Further, well-designed economic analyses would be useful in exploring these questions among varied groups of patients.
Lee, M.K., Yun, Y.H., Park, H.A., Lee, E.S., Jung, K.H., & Noh, D. (2014). A web-based self-management exercise and diet intervention for breast cancer survivors: Pilot randomized controlled trial. International Journal of Nursing Studies, 51, 1557–1567.
To investigate whether a web-based self-management exercise and diet intervention (WBSEDI) is feasible and effective in patients with breast cancer to promote exercise and diet
Control versus 12-week WBSEDI. WBSEDIs were encouraged to be completed at least twice weekly. Education content included enhancing exercise and diet behavior in survivors; the importance of weight management; barriers to sustaining exercise and diet; planning exercise and diet; outcomes of regular exercise and diet; and exercise and diet recommendations for cancer survivors. Content was divided into modules based on patients' stage of change. The type and duration of exercise was decided by the patient. Diets were based on daily calorie requirements and food-group unit recommendations. Automatic feedback was provided in the module. The control group received a 50-page booklet of module information without transtheoretical model use.
Pilot randomized controlled trial
89% of the experimental group consistently participated in the intervention. There was a significant increase in the intervention group for moderate-intensity exercise of 150 minutes per week (p < .0001) and five servings fruits and vegetables per day (p = .001). Secondary outcomes were significant improvements in the intervention group at 12 weeks for physical functioning (p = .023), fatigue (p = .032), and appetite loss (p = .034). The stage of change for exercise and fruit and vegetable consumption was significantly higher (p < .0001 and p = .029).
The intervention arm had a low attrition rate with a high percentage of participation. Secondary outcomes such as fatigue were associated with improved primary outcomes, suggesting increased exercise and improved diet can have an effect on quality of life and function for breast cancer survivors. Patient stage of change can affect participation in interventions. The cost and implementation of web-based intervention was not discussed, which may limit some institutions in using it.
Web-based interventions may be effective for patients seeking lifestyle interventions that include ongoing support and feedback.
Lee, S., Jerng, U.M., Liu, Y., Kang, J.W., Nam, D., & Lee, J. (2014). The effectiveness and safety of moxibustion for treating cancer-related fatigue: A systematic review and meta-analyses. Supportive Care in Cancer, 22, 1429–1440.
PHASE OF CARE: Multiple phases of care
Insufficient data to make recommendations regarding safety or efficacy of moxibustion on fatigue among Chinese patients with cancer
Insufficient data to make recommendations regarding safety or efficacy of moxibustion on fatigue among Chinese patients with cancer
Techniques of moxibustion requires specialized training not usually available in United States. Access to qualified practitioners, lack of an appropriate placebo or sham control, and frequency of treatment administration to outpatients would make additional studies of safety and efficacy difficult for nurse researchers to conduct.
Lee, J., & Oh, H. (2013). Ginger as an antiemetic modality for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis. Oncology Nursing Forum, 40, 163-170.
To review and evaluate the evidence on the effect of ginger as a modality for management of chemotherapy-induced nausea and vomiting (CINV)
Databases searched were MEDINE, CINAHL, Embase, Cochrane central register, Korean Studies information service system, and dissertation central.
Search keywords were chemotherapy, nausea, vomiting, chemotherapy induced nausea and vomiting, ginger, ginger extract and Zingiver officinale.
The reference lists of retrieved articles also were reviewed.
The inclusion criteria were not specifically stated, but all studies were double blind randomized controlled trials (RCTs).
The exclusion criteria were not stated. However, specific studies that combined ginger with another treatment, did not include sufficient information about the sample and intervention, and examined outcomes per episode of chemotherapy rather than by patient were excluded.
All patients were in active antitumor treatment.
Three of the studies compared ginger to placebo, and two compared it to metoclopramide or ondansetron. Most of the trials did not use an NK1 in the antiemetic regimen, which is the current recommended guideline. Side effects reported with ginger included drowsiness, sleepiness, dry mouth, thirst, heartburn or restlessness. One study reported bruising, flushing, or rash. Meta-analyses concluded that ginger had no significant effect on control of acute or delayed nausea or vomiting.
Results do not support the use of ginger and did not show an antiemetic effect of ginger for management of CINV.
Ginger does not appear to be effective for the management of CINV.
Lee, H.Y., Kim, H.K., Lee, K.H., Kim, B.S., Song, H.S., Yang, S.H., ... Park, H.S. (2014). A randomized double-blind, double-dummy, multicenter trial of azasetron versus ondansetron to evaluate efficacy and safety in the prevention of delayed nausea and vomiting induced by chemotherapy. Cancer Research and Treatment, 46(1), 19–26.
To evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting (CINV)
A multi-center, prospective, randomized, double-dummy, double-blind, parallel-group trial.
Patients completed daily logs for nausea and vomiting frequency with visual analog scales (VAS) on days 1–6 post chemotherapy administration. Tests were administered on day 7 and week 4 +/– one week. The primary endpoint was the effective ratio of complete response for CINV, and the secondary end points were degree of nausea by treatment day (grade 0–3), complete control (CC of vomiting and nausea) by treatment day, physician’s global assessment (PGA) score on day 7, and VAS by treatment day. There was no significant difference between groups on the secondary endpoints.
The authors acknowledge that azasetron has shown safety and efficacy with CINV in previous studies. However, the effectiveness of azasetron (45%) and ondansetron (54.5%) towards a complete response to CINV did not support azasetron’s superiority over ondansetron.
Azasetron showed inferiority for controlling delayed CINV when compared to ondansetron. The authors recommend that further studies about 5-HT3 receptor antagonists are not necessary; the superiority of NK1 receptor antagonists is documented. There was no difference between the groups for degree of nausea or complete control by treatment day.
Other limitations/explanation: The authors did not identify limitations for the study. The data were gathered between May 2005 and December 2005 and may be “dated.” Azasetron is only available in Japan at this time. Day 7 visit was missed by 21 patients.
Findings will assist nurses with the prevention of CINV for patients receiving moderate to high levels of emetogenic chemotherapy. Azasetron was not found to be superior to ondansetron for the prevention of CINV for patients receiving moderate to high levels of emetogenic chemotherapy.
Lee, K.C., Yiin, J.J., & Chao, Y.F. (2016). Effect of integrated caregiver support on caregiver burden for people taking care of people with cancer at the end of life: A cohort and quasi-experimental clinical trial. International Journal of Nursing Studies, 56, 17–26.
To test the effects of an integrative, supportive intervention program for caregivers on caregiver strain and burden
Face to face sessions were done with caregivers to assess categories of caregiver burden, and then individually tailored interventions were provided in 30–40 minute individual sessions every two weeks until the patient expired. Telephone calls were done every other week to provide support and redirection to address areas of strain and burden. The intervention involved education, counseling regarding coping strategies, assistance in findings needed resources, and the provision of respite patient care. Patients in a different ward were allocated to a control group and received usual care. Usual care did not include proactive assessment to determine interventions. Ward assignment to control and intervention groups was done randomly. Participants were recruited when hospitalized and followed longitudinally. Data were collected every two weeks. All participants had access to a 24-hour help line.
Randomized, controlled, cohort, longitudinal trial
The analysis showed a significant group by time effect for caregiver burden scores (eta square 0.49, p < 0.001) and self-efficacy scores (eta square 0.46, p < 0.001). Those in the intervention group had higher self-efficacy and lower burden. There were no significant differences in patient symptom severity between groups.
The proactive assessment of caregiver stressors and individualized supportive and psychoeducational interventions reduced caregiver strain and burden and increased caregiver self-efficacy.
This study demonstrated that purposeful caregiver assessment and individualized planned interventions to support caregivers and work with them regarding their stressors was effective in reducing subjective caregiver strain and burden and improving self-efficacy during the last three months of the patient’s life. This study provided frequent caregiver contact with reassessment, enabling the identification of and response to changing needs.
Lee, J.Y., Park, H.Y., Jung, D., Moon, M., Keam, B., & Hahm, B.J. (2014). Effect of brief psychoeducation using a tablet PC on distress and quality of life in cancer patients undergoing chemotherapy: A pilot study. Psycho‐Oncology, 23, 928–935.
To examine the benefits of a single-session psychoeducational intervention using a tablet PC during chemotherapy
Patients were assigned to intervention or control groups according to their dates of informed consent rather than strict randomization. Study measures were obtained at baseline and two to four weeks later. The study group was given a single-session psychoeducational intervention using a tablet PC to administer the education.
Two-group trial
Compared to the control group, the intervention group showed a positive score change on the HADS scale. The mental component summary score of the SF-8, the IES-R avoidance subscale, the ISI, and the total score of the HADS scale were the following. HADS (p = .0002), SF-8 (p = .011), ISI (p = .021), and IES-R (p = .036) declined from baseline more in the intervention group. Scores did decline in both groups.
A tablet-based, 20-minute psychoeducational intervention could be an effective intervention for managing depression, sleep disturbance, and quality of life.
Lee, J., Dibble, S., Dodd, M., Abrams, D., & Burns, B. (2010). The relationship of chemotherapy-induced nausea to the frequency of pericardium 6 digital acupressure. Oncology Nursing Forum, 37, E419–E425.
To explain the relationship between the intensity of chemotherapy-induced nausea and vomiting (CINV) and the frequency of P6 digital acupressure in a group of patients with breast cancer who received moderately to highly emetogenic chemotherapy and applied P6 digital acupressure as an additional intervention for CINV control.
This was a secondary analysis of a multicenter, longitudinal, randomized, clinical trial that compared differences in CINV among three groups (P6 acupressure, placebo digital acupressure, and usual care). The original study was published in 2007.
Patients in the group receiving P6 acupressure in the parent study were instructed to perform digital acupressure for three minutes or point release at the P6 points on both arms in the morning plus an additional three minutes of acupressure to one arm whenever nausea occurred. Secondary analysis was conducted of this group’s data from the patient information questionnaire and daily log.
This was a multisite study conducted at 15 different sites in the United States.
All patients were in active treatment.
The study was design was a descriptive secondary analysis.
Nausea intensity was not found to be consistently related to frequency of acupressure use.
Types and dosages of antiemetics used were not described.
Based on the results of the parent study and the indepth secondary analysis of the acupressure group, patients with CINV may benefit from P6 acupressure throughout the first 11 days after chemotherapy. Because each patient is different, individualized patient teaching and resources for managing CINV are important.