Oki, E., Emi, Y., Kojima, H., Higashijima, J., Kato, T., Miyake, Y., . . . Maehara, Y. (2015). Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy (GENIUS trial): A placebo-controlled, double-blind, randomized phase III study. International Journal of Clinical Oncology, 20, 767–775.
To evaluate the effectiveness of goshajinkigan (GJG) in reducing peripheral neurotoxicity in patients receiving FOLFOX for colorectal cancer
Patients with colorectal cancer were randomized to receive either GJG 7.5 mg three times daily or placebo in a double-blind manner. The time to grade 2 or higher neuropathy was the primary endpoint.
PHASE OF CARE: Active antitumor treatment
Double-blind, placebo-controlled, randomized study
Time to grade 2 or higher neuropathy as described by Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and the DEB-NTC. Standardized questions regarding symptoms of neurotoxicity and examples of answers were used to facilitate accurate classification and grading of symptoms. Grades were determined by physicians and were documented in patient records.
A total of 142 patients were evaluable. Incidence of grade 1 peripheral neuropathy was 43.8% in the GJG group and 62.4% in the placebo group; incidence of grade 2 or higher was 50.6% in the GJG group and 31.2% in the placebo group. Time to development of neuropathy was also significantly less in the GJG group (p = 0.007). GJG did not reduce time to neuropathy even for grade 1. Adverse events other than neuropathy showed no difference between the two groups. Secondary endpoints of dose intensity and treatment cycle were higher in the GJG group (not significant).
GJG did not decrease the time to grade 2 neuropathy; in fact, it seems to have hastened development. There was some effect on the dose intensity and treatment cycle given, but this was not a significant difference.
A total of 155 patients in each arm were planned, but after a total of 155 patient enrolled, an interim analysis was performed and the study was stopped at that time because of findings that GJG was not as effective as hoped. Nurses must ask patients medications, including all supplements, to educate patients on potential interactions and potential harm from supplemental medications. This is marketed in Japan for treatment for diabetic neuropathy but does not seem to be effective for chemotherapy-induced neuropathy, and education of patients is key.
Oh, P.J., & Kim, J. 2016. The effects of nonpharmacologic interventions on cognitive function in patients with cancer: A meta-analysis. Oncology Nursing Forum, 43, E205–E217.
STUDY PURPOSE: To examine nonpharmacologic intervention effects on cognitive function in adult survivors of cancer, and to examine whether these effects are driven by psychological or behavioral intervention types
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Multiple phases of care
APPLICATIONS: Elder care
Eleven studies used psychological interventions, and three used behavioral interventions. All studies used standard care control groups, with intervention durations of two weeks to more than one year that included an average of 16 one-hour sessions. Psychological interventions used individual-based cognitive rehabilitation (n = 10) with three using computer-based retraining programs. Outcomes included subjective cognitive function (n = 5), attention (n = 6), memory (n = 8), executive function (n = 7), verbal ability (n = 3), and multiple domains (n = 7). Low risk bias assessments: Rrandomization (n = 5), allocation concealment (n = 3), blinded participants or personnel (n = 2), blinded personnel conducting outcome assessment (n = 4), attrition (n = 12), reporting bias (n = 14), monitoring procedures, and manual use (n = 13). Statistical heterogeneity ranged from none to moderate (I2 = 0%–68%). Significant treatment effects existed for nonpharmacologic interventions on memory (n = 8, d = 0.21, 95% confidence interval [CI] [0.04, 0.38], p = 0.02, I2 = 0%) and perceived cognitive function (n = 5, d = 0.41, 95% CI [0.2, 0.61], p < 0.001, I2 = 0%). Subgroup analysis for psychological interventions was significant for effect on perceived cognitive function (n = 3, d = 0.35, 95% CI [0.13, 0.58], p = 0.002, I2 = 0%).
The treatment effects of nonpharmacologic interventions significantly improved memory and perceived cognitive function. The meta-analysis indicated that psychological interventions significantly improved perceived cognitive function. No treatment effects from other interventions were observed, and no effects on cognitive performance in domains of executive function, attention, and verbal ability were observed. Most studies reviewed in this meta-analysis did not provide sufficient evidence to demonstrate improvement in cognitive performance. Further study is warranted using RCT designs to increase the sample pool to observe positive treatment effects.
Nonpharmacologic interventions, specifically those involving psychological interventions, have demonstrated improvements in memory and self-reported cognitive function in adult survivors of cancer.
Oh, B., Butow, P. N., Mullan, B. A., Clarke, S. J., Beale, P. J., Pavlakis, N., . . . Vardy, J. (2012). Effect of medical Qigong on cognitive function, quality of life, and a biomarker of inflammation in cancer patients: A randomized controlled trial. Supportive Care in Cancer, 20, 1235–1242.
To examine the effects of medical qigong on self-reported cognitive function in patients with cancer
Participants were randomized to 10 weeks of medical qigong or usual care. Self-reports of cognitive functioning were evaluated at baseline and at the conclusion of the 10-week intervention. The medical qigong program was a weekly 90-minute group class that included a 15-minute discussion of health, 30 minutes of gentle stretching and body movement in a standing position, 15 minutes of movement in a sitting position, and 30 minutes of meditation and breathing. Two sessions were offered each week; participants could attend one or both of the sessions but had to attend for a minimum of 7 of the 10 weeks. Participants also kept a diary.
The study was a stratified, randomized controlled trial of a subset of patients from a larger study.
Participants in the intervention group showed significant improvement in perceived cognitive functioning on both the EORTC QLQ-C30 (p = 0.014) and FACT-Cog (p = 0.029) compared to the control group (usual care) over time at 10 weeks' follow-up.
Results suggest that medical qigong may improve patients' perception of their cognitive functioning. However, further studies are needed with a larger sample size, objective measures, and longer follow-up to determine whether results are sustainable.
The study suggests that qigong may be beneficial in improving cognitive function in patients with cancer. However, the drop-out rate was significant at 33%. Drop outs occurred for multiple reasons, but it shows that qigong may not be a realistic intervention for some patients with cnacer. Further studies on the specific impacts qigong has on cognitive ability need to be conducted.
Ohno, T., Yanai, M., Ando, H., Toyomasu, Y., Ogawa, A., Morita, H., . . . Kuwano, H. (2011). Rikkunshito, a traditional Japanese medicine, suppresses cisplatin-induced anorexia in humans. Clinical and Experimental Gastroenterology, 4, 291–296.
To investigate the effect of Rikkunshito on ghrelin secretion and on cisplatin-induced anorexia in humans
Ten patients were randomly divided into two groups. Both groups received S-1 (80 mg/m²/day orally split into twice-a-day dosing after meals) plus chemotherapy for 21 consecutive days followed by a 14-day rest period. The total daily dose of S-1 was determined based on body surface area (BSA): 80 mg (BSA < 1.25 m²), 100 mg (BSA 1.25–1.5 m²), or 120 mg (BSA > 1.5 m²). Cisplatin 60 mg/m² was administered IV on day 8. All patients were administered 16 mg of dexamethasone and 3 mg of granisetron IV one hour before cisplatin infusion and 8 mg of dexamethasone on days 9 and 10. Group A was started on Rikkunshito for the first course of chemotherapy, followed by a second course of chemotherapy without Rikkunshito. Treatment with Rikkunshito was reversed for group B. During the intervention period, patients took Rikkunshito 7.5 g (2.5 g three times per day by mouth) before each meal on days 1–21. Patients in the control period did not take anything. Blood samples to assess acylated ghrelin levels were collected before and three hours after administration of the cisplatin. Patients were hospitalized after the administration of cisplatin and monitored for five days. The amount of oral intake of each meal was observed and scored, and the average oral intake during five days was calculated.
A crossover design was used.
Anorexia, nausea, and vomiting were scored according to National Cancer Institute common toxicity criteria.
During the Rikkunshito-on period, there was no significant decrease in the plasma concentration of acylated ghrelin between before and after administration. During the Rikkunshito-off period, the average concentration of plasma-acylated ghrelin three hours after cisplatin administration decreased from preadministration levels but not statistically significantly.
The average oral intake in the Rikkunshito-on period was significantly larger than that in the Rikkunshito-off period (p = 0.0496). The grade of anorexia was significantly lower in the Rikkunshito-on period than in the Rikkunshito-off period (p = 0.0441), and the average oral intake in the Rikkunshito-on period was significantly larger than that in the Rikkunshito-off period. The grade of nausea was not significant; however, the grade in the Rikkunshito-on period tended to be lower. The difference in grade of vomiting was not significant. The time to treatment failure rates during the Rikkunshito-on period were not different. Hypertension, edema, hypokalemia, pseudohyperaldosteronism, hepatic toxicity, and transaminitis have been previously reported but did not appear to be more significant in the Rikkunshito-on or -off period for this study.
Rikkunshito might prevent anorexia induced by cisplatin, and the prophylactic administration of Rikkunshito was felt to be effective in chemotherapy with cisplatin. Patients could continue their treatment on schedule.
Rikkunshito may be effective at preventing anorexia induced by cisplatin, but the small sample size makes it unlikely that this data can be generalized. Additional studies are necessary.
Ohno, T., Mine, T., Yoshioka, H., Kosaka, M., Matsuda, S., De Kerckhove, M., . . . Izumida, R. (2014). Management of peripheral neuropathy induced by nab-paclitaxel treatment for breast cancer. Anticancer Research, 34, 4213–4216.
To evaluate the effects of prophylactic compression therapy using stockings and sleeves combined with oral goshajinkigan, mecobalamin, and lafutidine on the prevention of nab-paclitaxel-induced peripheral neuropathy (PN)
The control and treatment groups received 260 mg/m2 one time every three weeks from June 2012 to April 2013. Patients in the prophylactic treatment group wore stockings and sleeves from the beginning of nab-paclitaxel infusion, continuing for total of 24 hours. The treatment group also received prophylactic goshajinkigan (7.5 g per day), mecobalamin (1,500 mcg per day), and lafutidine (20 mg day) over the course of treatment. Assessments for side effects, including PN grade, were first conducted by a pharmacist then by a physician. If a subject proceeded to chemotherapy, a third set of tests were conducted by a nurse. For the treatment group, the nurse confirmed use of compression stockings and sleeves prior to chemotherapy.
Parallel-group trial
After the first cycle of chemotherapy, there was a significant difference in presence of PN (all grades) between groups. PN occurred in five out of seven subjects in the control group versus one out of seven subjects in the treatment group. The average grade of PN improved over cycles one through four in the treatment group.
In this small, nonrandomized trial, the grade of PN during one to four cycles of nab-paclitaxel therapy at 260 mg/m2 was lower in the treatment group receiving compression therapy and prophylactic medications than the control group.
Combination prophylaxis with compression sleeves and stockings and medication (goshajinkigan 7.5 mg day, mecobalamin 1,500 mcg per day, and lafutidine 20 mg per day) needs additional investigation of its use for the treatment for nab-paclitaxel-induced PN. The safety, efficacy, benefit, and generalizability for appropriate target populations of this regimen also requires additional study in large, randomized, controlled trials. This study report had numerous flaws and limitations.
Ohmagari, N., Kurai, H., Yamagishi, Y., & Mikamo, H. (2014). Are strict isolation policies based on susceptibility testing actually effective in the prevention of the nosocomial spread of multi–drug-resistant gram-negative rods? American Journal of Infection Control, 42, 739–743.
There is an emerging problem of growing multi-drug resistant gram-negative rods (MDR-GNRs), and rapid and sensitive detection is difficult. There is no consensus regarding the list of drug-resistant bacteria to target for infection control and infection control policies for multi-drug resistant gram-negative organisms (DR-GNRs) often lack strong evidence to identify the minimum interventions needed to reduce their transmission. The authors were trying to determine if horizontal transmission can be prevented by detecting and appropriately controlling targeted drug-resistant bacilli before they acquire resistance.
In January 2005, a prevention policy against MDR-GNR infection was implemented. After isolating strains that met the defined criteria, contact precautions were implemented. Active interventions, including approval for specific antibiotics prior to use and regulating the prescription of certain antimicrobials, were not applied. The preintervention period (January 1, 2003 to December 31, 2004) was compared to intervention period (January 1, 2005 to December 31, 2010).
Retrospective study (pre- and postintervention) based on the examination of a bacterial testing database
MDR-GNRs were defined as gram-negative bacilli that were insensitive to at least three of the specified classes of antimicrobials, metallo-beta-lactamase-producing bacilli, and extended spectrum beta-lactamase (ESBL)-producing bacilli. Strains of MDR-GNRs were isolated at least 48 hours after admission, and only newly detected stains were included and excluded cases in which the same strain was later detected in the same patients. Each species was included if multiple strains were isolated from the same patients.
The overall incidence density rate of all multi-drug resistant nonfermenting gram-negative bacilli over the eight-year study period (2003–2010) was 0.31 per 10,000 patient days. Rates did not increase significantly between the preintervention period (0.15 per 10,000 days) and the intervention period (0.35 per 10,000 days). The overall incidence rate of MDR enterobacteriaceae infections was 0.49 per 10,000 days. However, the preintervention period was 0.19 per 10,000 days, and the intervention was 0.56 per 10,000 days, representing a statistically significant decrease.
The study increased the detection of enterobacteriaceae bacteria with an increase in ESBL-producing organisms, but no significant change in detection rate of MDR non-glucose-fermenting bacilli was found. Contact precautions were implemented to limit the emergence of MDR-gram negative bacilli, but the efficacy of these policies was deemed uncertain.
MDR-GNRs are an emerging worldwide problem. Nurses have a significant responsibility to ensure proper precautions are taken as quickly as possible when these organisms are detected. Nurses should ensure that the patient is properly educated, but more importantly, should implement contact precautions and ensure that other healthcare providers are following these precautions.
Ohlsson-Nevo, E., Karlsson, J., & Nilsson, U. (2016). Effects of a psycho-educational programme on health-related quality of life in patients treated for colorectal and anal cancer: A feasibility trial. European Journal of Oncology Nursing, 21, 181–188.
To evaluate the effects of a psychoeducational program on quality of life (QOL) among patients treated for colorectal and anal cancer
After patients were discharged post-initial surgery, they were invited to participate in the program. Patients completed a baseline assessment and then were randomized to the study program or usual care. Patients in the control group received standard care, including a phone call on postoperative day 3, a follow-up surgical visit after one month, and an appointment with the social worker/counselor if desired. Control group participants were offered the educational program after the end of the study. The intervention included seven meetings with informational lectures delivered once weekly in groups of about 10 patients. Caregivers could attend educational sessions. Lectures were followed by group discussion among patients only to reflect on the topic among peers and speak about worries and experiences. Study assessments were done at 1, 6, and 12 months after study entry.
At one month, the intervention group reported better overall mental health status (effect size = 0.51, p = 0.01). Bodily pain score were more positive in the intervention group at six months (p = 0.01), but not significantly different from that of control patients at any other time point, although among the intervention group, average pain scores improved over time, while among controls remained essentially stable.
The psychoeducational program evaluated here was associated with better mental health status and bodily pain subscale scores over time.
The psychoeducational program tested here appeared to have positive health-related QOL benefits for participants. Ongoing research is needed to identify the most beneficial timing, amount, content, and format of educational and counseling for short- and long-term benefit to patient with various cancer types and treatment regimens.
Ohigashi, S., Hoshino, Y., Ohde, S., & Onodera, H. (2011). Functional outcome, quality of life, and efficacy of probiotics in postoperative patients with colorectal cancer. Surgery Today, 41, 1200–1206.
To compare functional outcome and quality of life (QOL) in patients who received surgical resection for rectal versus colon cancer, and to review the efficacy of the use of probiotics in bowel function afterwards.
A questionnaire was sent to 193 patients with non–stage IV colon cancer. Some patients with stage III disease received adjuvant chemotherapy over the six-month postoperative period, but no patients were undergoing chemotherapy when the questionnaire was administered. Seventy-seven respondents agreed to take probiotics. Patients received a probiotic that contained Bacillus natto and Lactobacillus acidophilus as the principal ingredients.
Patients took three tablets after meals TID for a total of nine tablets. The questionnaire was readministered three months after probiotic initiation.
This was a questionnaire-based study with a cross-sectional design.
Some improvements were observed in all groups after the administration of probiotics. Changes in defecation and related symptoms differed according to disease location over time. The role of probiotic use cannot be determined from this study report.
The study did not provide sufficient evidence to demonstrate the efficacy of probiotic use for managing bowel symptoms in patients after colorectal surgery. However, the study showed differences in bowel symptoms based on initial tumor location and surgical area.
Ohashi, M., Saka, M., Katayama, H., Okinaka, K., Morita, S., Fukagawa, T., & Katai, H. (2015). A prospective cohort study to evaluate the feasibility of intraoperative antimicrobial prophylaxis in open gastrectomy for gastric cancer. Surgical Infections, 16, 833–839.
To evaluate the feasibility of intraoperative antimicrobial prophylaxis compared to conventional prophylaxis in patients undergoing elective open gastrectomy
Procedures for prophylaxis were conducted in two stages during six months. In the first stage, patients received four IV doses of cebazolin 1 g at 12-hour intervals beginning 30 minutes before surgery. In the second cohort, patients received the same agent at three-hour intervals beginning 30 minutes before surgery until the end of surgery. Perioperative care was conducted in a standard approach in both cohorts.
PHASE OF CARE: Active antitumor treatment
Cohort comparison—prospective
The definition of surgical site infection (SSI) was based on the Centers for Disease Control and Prevention surveillance system.
The overall SSI rate was 9.2%, and all were treated successfully with antibiotics. No statistically significant difference existed between cohorts.
Provision of antimicrobial prophylaxis immediately before and during the operative procedure appears to be feasible and sufficient for the prevention of SSI in patients undergoing gastrectomy.
Provision of antibiotic prophylaxis to reduce SSI 30 minutes before and during the surgical procedure may be sufficient. This study is limited by its design. Additional research is needed to determine the most effective timing and duration of antibiotic prophylaxis for SSI prevention in patients undergoing various types of surgical procedures.
Oh, P.J., & Kim, S.H. (2010). Effects of a brief psychosocial intervention in patients with cancer receiving adjuvant therapy. Oncology Nursing Forum, 37, E98–E104.
To test the effects of a brief psychosocial intervention (BPIC) delivered using CD-ROM on psychosocial and behavioral outcomes in patients with cancer undergoing adjuvant treatment
Participants viewed a 15-minute CD-ROM education program and received a booklet as well as 20 minutes of health education in the first session. A follow-up 15-minute telephone session was delivered one week later. The program focused on health education, coping, and stress management.
Patients were undergoing the active treatment phase of care.
A randomized controlled trial design was used.
There were no differences between groups for helplessness, hopelessness, anxiety, or depression. There were significant differences in fighting spirit (p = 0.005) and self-care behaviors (p < 0.001) between the two groups. The scores increased in the experimental group but declined in the control group.
Findings support effectiveness of the intervention in improving fighting spirit and self-care behaviors; however, the intervention had no significant effect on anxiety or depression.
Mean anxiety and depression scores at baseline were relatively low, suggesting very limited potential for these outcomes to be significantly improved.