Gagnon, B., Low, G., & Schreier, G. (2005). Methylphenidate hydrochloride improves cognitive function in patients with advanced cancer and hypoactive delirium: A prospective clinical study. Journal of Psychiatry Neuroscience, 30, 100–107. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC551162/?tool=pubmed
The study was conducted to investigate the clinical improvement observed in patients with advanced cancer and hypoactive delirium after the administration of methylphenidate hydrochloride (MPH).
First, a 10 mg test dose of MPH was given orally to all participants. If there were no distressing side effects, participants were given 10 mg of MPH twice daily at 8 am and 12 pm. Follow-up was daily for hospital inpatients and every three to four days for patients in the community. Doses of MPH were increased in 5 mg increments to reach the maximum tolerable dose for the patient’s satisfaction and the resolution of delirium.
Measurements were taken before delirium and delusions (T0), at baseline prior to the MPH treatment (T1), one hour after after the MPH dose (T2), and when a stable dose was achieved (T3).
The Mini-Mental State Examination was used as an assessment tool on a daily basis for inpatients and every three to four days for outpatients.
The study utilized a case series design for patients with advanced cancer and hypoactive delirium.
All participants had a positive response to MPH that included increased alertness, partial-to-complete resolution of psychomotor retardation, normalization of slurred speech, and a marked increase in energy levels.
All 14 participants showed improvement in their cognitive function as documented by the MMSE. In 13 patients, the median MMSE score improved to 28 (mean = 27.8, standard deviation = 2.4, p = 0.02) compared with the median score one hour after the first dose of MPH. One patient died before reaching a stable dose of MPH.
The pretreatment MMSE median score was 21 (mean = 20.9, standard deviation = 4.9), which improved to a median of 27 (mean = 24.9, standard deviation = 4.7) after the first dose of MPH (p < 0.001).
MPH improved alertness and general cognitive function in a small sample of patients with advanced cancer. However, due to confounding issues with disease and treatment responses, more research is warranted to determine its effectiveness.
Gagnon, B., Murphy, J., Eades, M., Lemoignan, J., Jelowicki, M., Carney, S., . . . Macdonald, N. (2013). A prospective evaluation of an interdisciplinary nutrition-rehabilitation program for patients with advanced cancer. Current Oncology, 20, 310-318.
To evaluate the degree to which a multi-component rehabilitation program improves symptom control and quality of life in patients with advanced cancer
The intervention was a 10-12 week program offered by a multidisciplinary team, consisting of nutritional counseling, a collaborative care plan based on patient goals, a palliative care physician specialist focused on symptom-related medical interventions, a pivot nurse for care coordination and case management, and an exercise component with semi-weekly exercise sessions with a physical therapist and a home exercise plan. Occupational therapy was provided and focused on self care, leisure, and productivity. Patients were assessed at baseline and during their final clinic visit at the end of the study.
SITE: Single site
SETTING TYPE: Outpatient
LOCATION: McGill University Cancer Center, Montreal, Canada
Quasi-experimental
Change in symptom severity was analyzed and Cohen’s d was used to calculate effect size. Severity of depression from ESAS declined (p <. 0001, d = 0.7); anorexia declined (p < .0001, d = .4); pain declined (p < .0001, d = .4); physical and general fatigue declined (p < .0001, d = .7); mental fatigue declined (p < .0005, d = .4); and level of distress and difficulty coping declined (p < .0001).
The multi-component rehabilitation program provided here resulted in a significant improvement in multiple symptoms and a reduction in distress and difficulty coping.
A multi-component, multi-disciplinary rehabilitation and palliative care program can provide effective improvement of multiple symptoms in patients with advanced disease.
Gafter-Gvili, A., Paul, M., Fraser, A., & Leibovici, L. (2007). Effect of quinolone prophylaxis in afebrile neutropenic patients on microbial resistance: Systematic review and meta-analysis. Journal of Antimicrobial Chemotherapy, 59, 522.
To compare antibiotic prophylaxis with placebo or no intervention or another antibiotic in patients with afebrile neutropenia
DATABASES USED: Cochrane Cancer Network Register of Trials (December 2004), Cochrane Library (Issue 4, 2004), EMBASE (January 1980–December 2004), and MEDLINE (January 1966–December 2004); the reference lists of all the articles also were searched.
FINAL NUMBER STUDIES INCLUDED = 95 RCTs
TOTAL PATIENTS INCLUDED IN REVIEW = 9,283 patients comparing prophylactic antibiotics with placebo, no intervention, or other prophylactic antibiotics
KEY SAMPLE CHARACTERISTICS: Sixty-four trials included only patients with hematologic malignancies, and nine trials consisted of more than 80% of patients with solid tumors. Twenty-seven studies included patients undergoing bone marrow transplantation (BMT).
Prophylactic antibiotics significantly decreased
Fluoroquinolones, when compared with placebo or no intervention, decreased the risk of
The relative risk for adverse events was not statistically significant (relative risk 1.30 [confidence interval 0.61–2.76]). Comparatively, in trials comparing trimethoprim/sulfamethoxazole with placebo or no intervention, the corresponding estimates were statistically significant (relative risk 2.42 [confidence interval 1.35–4.36] and 3.63 [confidence interval 1.32–9.98], respectively). Moreover, in trials that compared fluoroquinolones with trimethoprim/sulfamethoxazole, less resistance developed to fluoroquinolones in the fluoroquinolone group than that developed to trimethoprim/sulfamethoxazole in the trimethoprim/sulfamethoxazole group (relative risk 0.45 [confidence interval 0.27–0.74]). When fluoroquinolones were compared with placebo, the number of fungal infection episodes did not statistically or significantly differ (relative risk 0.83 [confidence interval 0.56–1.22]).
Fluoroquinolone prophylaxis increased the risk of fluoroquinolone-resistant infections, but the increased risk was not statistically significant (relative risk 1.69 [confidence interval 0.73–3.92]).
Gafter-Gvili, A., Fraser, A., Paul, M., Vidal, L., Lawrie, T.A., van de Wetering, M.D., . . . Leibovici, L. (2012) Antibiotic prophylaxis for bacterial infections in afebrile neutropenic patients following chemotherapy. Cochrane Database of Systematic Reviews, 1, CD004386.
The purpose of this meta analysis and sytematic review was to evaluate the effect of antibiotic prophylaxis on mortality and infection in neutropenic patients. In addition, subgroups of patients who may benefit the most were identified, and whether or not the effectiveness of different antibiotic regimens were similar was evaluated, as were the adverse effects of different regimens and the emergence of quinolone-resistant bacteria.
119 total references were retrieved. Cochrane Handbook for Systematic Reviews methods were used to evaluate and commend on the literature used.
Active antitumor treatment
Antibiotic prophylaxis resulted in significant reduction in risk of mortality across 46 trials analyzed (RR = 0.66, 95% confidence interval [CI] [0.55, 0.79], p < 0.00001). The greatest effect was with quinolones, although differences between regimens was not statistically significant. The effect was larger for trials in which prophylaxis was begun at the onset of neutropenia. An advantage was seen for all quinolones except for norfloxacin. Antibiotic prophylaxis significantly reduced infection-related mortality (RR = 0.61, 95% CI [0.48, 0.77], p = 0.04), decreased occurrence of fever, documented infection, and occurrence of bacteremia. Quinolones and TMP-SMZ were both associated with side effects that were mostly diarrhea and nausea. TMP-SMZ was associated with drug resistant bacteria cultures (RR = 2.42, 95% CI [1.35, 4.36]). With quinolones, no significant differences were noted between study groups compared to placebo or other interventions. Addition of gram-positive coverage did not show any apparent benefits in terms of mortality.
Findings support use of quinolones as prophylaxis of choice since they reduced risk of death compared to placebo or not intervention and were generally associated with fewer side effects and less resistant bacterial cultures in treated patients. Levofloxacin or ciprofloxacin are recommended.
Prophylactic quinolone antibiotic therapy is recommended for patients with hematologic cancers and those who are likely to develop neutropenia. Additional research is needed to better define patients with solid tumors that may benefit from antibiotic prophylaxis. In most studies, prophylaxis was begun when chemotherapy was initiated, rather than when neutropenia occurred. Prophylaxis should be accompanied by surveillance to monitor quinolone-resistant gram-negative bacteria and other resistant organisms.
Gafter-Gvili, A., Fraser, A., Paul, M., & Leibovici, L. (2005). Meta-analysis: Antibiotic prophylaxis reduces mortality in neutropenic patients. Annals of Internal Medicine, 142(12, Pt. 1), 979995.
To compare antibiotic prophylaxis with placebo, no intervention, or another antibiotic to prevent bacterial infections in patients with afebrile neutropenia
DATABASES USED: Electronic searches on the Cochrane Cancer Network Register of Trials (2005), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2005), MEDLINE (1966–2005), EMBASE (1980–2005), and abstracts of conference proceedings; references of identified studies; the first author of each included trial was contacted.
FINAL NUMBER STUDIES INCLUDED = 101
TOTAL PATIENTS INCLUDED IN REVIEW: 12,599
KEY SAMPLE CHARACTERISTICS: RCTs or quasi-RCTs performed from 1973–2005; patients with cancer and neutropenia as a result of chemotherapy or bone marrow transplantation
Antibiotic prophylaxis significantly decreased the risk of death when compared with placebo or no intervention (RR 0.66 [95%CI 0.55 to 0.79]). The authors estimated the number needed to treat in order to prevent one death from all causes as 50 (95% CI 34 to 268). Prophylaxis with any antibiotic resulted in a significant decrease in the risk of infection-related death (RR 0.59 [95% CI 0.47 to 0.75]) and in the occurrence of fever (RR 0.77 [95% CI 0.74 to 0.81]). Quinolone prophylaxis reduced the risk for all-cause mortality (RR 0.52 [95% CI, 0.37 to 0.74] and the risk of infection-related mortality (RR 0.49 [95% CI 0.31 to 0.77]).
Antibiotic prophylaxis resulted in a significant decrease in the occurrence of clinically documented infection (RR 0.66 [95% CI 0.61 to 0.73]), microbiologically documented infection (RR 0.53 [95% CI 0.48 to 0.58]), microbiologically documented gram-negative infection (RR 0.38 [95% CI 0.32 to 0.45]), microbiologically documented gram-positive infection (RR 0.44 [95% CI 0.38 to 0.51]), and bacteremia (RR 0.52 [95% CI 0.47 to 0.59]. Quinolone prophylaxis reduced the risk of bacteremia (RR 0.58 [95% CI 0.50 to 0.68]. When compared to placebo or no intervention, all prophylactic antibiotics caused more side effects (RR 1.59 [95% CI 1.37 to 1.85]. There was no statistically significant difference in the number of episodes of fungal infection when prophylactic antibiotics were compared to placebo (RR 1.07 [95% CI 0.83 to 1.37, 38 studies, 2,682 participants]).
When compared to placebo, patients given quinolones and sulfamethoxazole/trimethoprim (SMZ-TMP) were found to be at increased risk of harboring bacilli resistant to the specific drug than patients receiving placebo (RR 1.47 [95% CI 1.08 to 2.01]). For quinolones, the RR was 1.18 (95% CI 0.81 to 1.70) and for SMZ-TMP, 2.42 (95% CI 1.35 to 4.36). When quinolones were compared to SMZ-TMP, the following were significantly reduced: microbiologically documented infections (RR 0.72 [95%CI 0.6 to 0.86]) (comparison 5.2), gram-negative infections (RR 0.21 [95% CI 0.13 to 0.36]) (comparison 6.2), gram-negative bacteremia (RR 0.35 [95% CI 0.21 to 0.59]), and side effects (RR 0.74 [95%CI 0.63 to 0.87]). The addition of antibiotic against gram-positive infection to quinolones resulted in a significant decrease in the number of bacteremic episodes (RR 0.72 [95%CI 0.57 to 0.92], gram-positive infections (RR 0.49 [95% CI 0.37 to 0.64], and gram-positive bacteremia (RR 0.61 [95% CI 0.45 to 0.83]), and also in more side effects.
Gadsby, J. G., Franks, A., Jarvis, P., & Dewhurst, F. (1997). Acupuncture-like transcutaneous electrical nerve stimulation within palliative care: a pilot study. Complementary Therapies in Medicine, 5, 13–18.
Acupuncture-like transelectrical nerve stimulation (AL-TENS) with low-frequency, high-intensity stimulation using acupuncture points for emesis and analgesia was delivered by a nurse practitioner in five consecutive daily treatments. The study was divided into three groups: AL-TENS, standard care, and standard care plus placebo.
The study was a pilot study and a double-blind, randomized, controlled trial.
No significant differences were observed, but the study was underpowered and groups were not equivalent in symptoms at baseline.
Nurses should be trained in the use of AL-TENS and identification of acupuncture points. Future trials focused on fatigue are recommended.
Gabrail, N., Yanagihara, R., Spaczynski, M., Cooper, W., O'Boyle, E., Smith, C., & Boccia, R. (2015). Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: Results of two phase II trials. Cancer Management and Research, 7, 83-92.
To determine the pharmacokinetics, safety, and efficacy of two dosing regimens of APF530
There were two separate studies reported in this paper. The first study included 45 patients and used three escalating dosing schedules of 250 mg, 500 mg, or 750 mg. The second study included 35 patients with two dosing schedules of 250 or 500 mg. Safety and efficacy were reported. Drug levels were measured from predose to 168 hours after administration. Doses were given via subcutaneous injection in the abdomen prior to chemotherapy. All patients also received dexamethasone.
Prospective
Both studies met the primary objective by defining pharmacokinetics. Adverse events did not appear to be dose-related. Most were mild to moderate and were unrelated to the study drug. Injection site reactions were low and were not associated with dosing, and 17.7% of erythema was reported in the 250 mg arm. No erythema was reported in the 750 mg arm. The plasma concentrations of granisetron were maintained for seven days with a single dose of the drug. Preliminary data demonstrated another option for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. Patients treated with APF530 at 250 or 500 mg obtained complete response 83% of the time in the acute-onset and delayed-onset phases. Complete control was obtained in 76%. Nausea was controlled almost as well as emesis. Nausea reports were mostly mild.
Granisetron exposure was maintained for seven days with a single dose of subcutaneous AFP530. Mild injection site irritation was noted. Nausea was mild, and nausea and vomiting were controlled in the acute and delayed phases.
This could be another option for treating chemotherapy-induced nausea and vomiting, but it is possible that this treatment causes unnecessary discomfort when oral and transdermal approaches are available. This is very preliminary data, and the study did not compare this treatment to standard care. Additional research to determine the usefulness of this drug for chemotherapy-induced nausea and vomiting is needed.
Gabay, M. (2006). Absorbable hemostatic agents. American Journal of Health-System Pharmacy, 63, 1244–1253.
PURPOSE: To review absorbable hemostatic agents including pharmacology, clinical efficacy, adverse events and toxicities, dosage and administration, and safety issues
Discusses nine different agents and the different composition of each (e.g., porcine or bovine gelatin, bovine collagen or oxidized cellulose). The two newest agents (approved as U.S. Food and Drug Administration devices, not drugs) are FloSeal® and CoStasis®, and these products include bovine thrombin.
Fu, M.R., Axelrod, D., & Haber, J. (2008). Breast-cancer-related lymphedema: Information, symptoms, and risk-reduction behaviors. Journal of Nursing Scholarship: An Official Publication of Sigma Theta Tau International Honor Society of Nursing/Sigma Theta Tau, 40(4), 341–348.
To explore the effect of providing lymphedema information on breast cancer survivors’ symptoms and practice of risk-reduction behaviors
All data collection was completed in person. The first author was available to answer questions and assist participants with physical disabilities (i.e., to provide help with reading, marking, or writing). Data were collected from August 22, 2006–May 1, 2007 in New York City, NY.
The study took place at New York University Cancer Center.
The study used a cross-sectional, descriptive design.
The study used the Lymphedema and Breast Cancer Questionnaire to assess lymphedema-related symptoms and the Lymphedema Risk-Reduction Behavior Checklist.
Fifty-seven percent of patients reported that they received lymphedema information. On average, participants had three lymphedema-related symptoms. Only 18% of participants were free of symptoms. Participants who received information reported significantly fewer symptoms (t = 3.03, p < 0.00) and practicing more risk-reduction behaviors (t = 2.42, p = 0.01).
Providing lymphedema information has an effect on symptom reduction and more risk-reduction behaviors being practiced among survivors of breast cancer.
In the study, nurses were ranked as the second-most important source of lymphedema information or education after pamphlets. In clinical practice, nurses and other healthcare professionals could consider taking the initiative to provide adequate and accurate information and engage survivors of breast cancer in supportive dialogues concerning lymphedema risk reduction
Furukawa, N., Kanayama, S., Tanase, Y., & Ito, F. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin. Supportive Care in Cancer, 23, 3317–3322.
To evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 versus 3 of Decadron in patients with gynecologic cancer receiving carboplatin and paclitaxel (TC); to evaluate the efficacy of a one-day versus three-day Decadron regimen (primary endpoint was complete response in the delayed phase)
All patients received an intravenous prophylactic of Decadron at 20 mg within 15 minutes of a PAL dose of 0.75 mg 30 minutes before chemotherapy. Patients in the DEX1 arn received no further Decadron. Patients in the DEX3 arm received Decadron on days 2 and 3 at 8 mg.
Single-institution, prospective, randomized, open-label study
The authors noted that there was no significant difference between groups in complete response, complete control, or total CINV in the acute and delayed phases. There was no significant difference between groups in the rate of severe nausea. The CR rates in the delayed phase were not statistically different in the three-day group (76.9%) versus the one-day group (69.8%). The use of palonosetron and Decadron appears to be equally effective in treatment of delayed CINV for patients receiving paclitaxel and carboplatin.
The use of Decadron was effective with one-day use compared to three-day use. The side effect profile of steroids is very robust, meaning that fewer days of their usage with good control could improve patients' quality of life.
Based on the results of this study, dexamethasone is effective after only one day of use compared to three days of use. The side effect profile of steroids is robust, so fewer days of their use with adequate CINV control could improve patients' quality of life.