Matsuda, C., Munemoto, Y., Mishima, H., Nagata, N., Oshiro, M., Kataoka, M., . . . Kono, T. (2015). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy and Pharmacology, 76, 97–103.
To determine if TJ-1 (hangeshanshinto), a Japanese traditional herbal medicine, prevents and controls chemotherapy-induced oral mucositis
Patients who developed greater than World Health Organization (WHO) grade 1 oral mucositis during the first screening cycle of chemotherapy were eligible for a central 1:1 randomization to the study or control group. Three times each day, patients dissolved 2.5 g of TJ-14 or a placebo in 50 ml of water and rinsed the oral cavity. Patients were trained in the clinic. Treatment started on the first day of chemotherapy and continued for 14 days. Assessments using the WHO oral mucositis scale were done three times per week on nonconsecutive days during the screening cycle and treatment cycles 1 and 2. Assessments continued for three weeks or until mucositis returned to grade 0. Safety and adverse events were assessed.
Multi-institutional, double-blinded, placebo-controlled, randomized, phase 2 trial
There was no significant difference in the incidence and severity of oral mucositis between the groups. The duration of grade ≥ 2 mucositis was 5.5 days in the treatment group and 10.5 days in the placebo group.
This study did not meet its primary endpoint. TJ-14 demonstrated a potential treatment effect on mucositis ≥ grade 2 .
TJ-14 is a Japanese traditional herbal medicine consisting of a mixture of seven herbs. Additional study is needed to fully evaluate its effectiveness.
Matourypour, P., Vanaki, Z., Zare, Z., Mehrzad, V., Dehghan, M., & Ranjbaran, M. (2016). Investigating the effect of therapeutic touch on the intensity of acute chemotherapy-induced vomiting in breast cancer women under chemotherapy. Iranian Journal of Nursing and Midwifery Research, 21, 255–260.
To determine the effect of therapeutic touch on chemotherapy-induced nausea and vomiting (CINV)
Patients were randomly assigned to one of three groups, control receiving no intervention, therapeutic touch, and a placebo intervention. The researcher received training in therapeutic touch and performed these interventions. In the placebo group, the researcher moved her hand around the body to pretend an act of therapeutic touch. CINV was assessed immediately before the intervention and again 24 hours after chemotherapy. Patients were receiving triplet antiemetic prophylaxis.
Vomiting intensity was lower in the intervention group compared to the controls (p < 0.0001), but no difference existed between the intervention and placebo groups.
The study results suggested that therapeutic touch may provide a placebo effect to reduce CINV. The efficacy of actual therapeutic touch was not demonstrated compared to placebo.
The findings did not show the effectiveness of therapeutic touch compared to a placebo intervention to prevent CINV. They do suggest a potential placebo effect for therapeutic touch. This study had several limitations.
Mattila, E., Leino, K., Paavilainen, E., & AstedtKurki, P. (2009). Nursing intervention studies on patients and family members: A systematic literature review. Scandinavian Journal of Caring Sciences, 23, 611–622.
To identify the targets of intervention studies and obtain findings that will help in planning future intervention studies, support nursing, and promote the introduction of new family-centered nursing methods
The initial search yielded 323 articles. The final analysis included 31 articles that met inclusion criteria. Evidence was assessed using the Finnish Federation of Nurses’ criteria, which is described in the article. Content analysis of interventions was used. The RE-AIM model was used to examine study findings. This model includes dimensions of reach, efficacy, adaptation, implementation, and maintenance. Only six of the studies were identified as a high level of evidence using the stated criteria.
Massa, E., Astara, G., Madeddu, C., Dessi, M., Loi, C., Lepori, S., & Mantovani, G. (2009). Palonosetron plus dexamethasone effectively prevents acute and delayed chemotherapy-induced nausea and vomiting following highly or moderately emetogenic chemotherapy in pre-treated patients who have failed to respond to a previous antiemetic treatment: Comparison between elderly and non-elderly patient response. Critical Reviews in Oncology/Hematology, 70, 83–91.
To determine the effectiveness of palonosetron in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) for highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in patients who had failed to respond to a different antiemetic 5-HT3 antagonist during the first cycle; to determine differences in response between older adults and younger patients
On day 1, patients received 16 mg dexamethasone plus 250 mcg IV palonosetron before chemotherapy administration. For prophylaxis, patients received 8 mg dexamethasone every 12 hours on days 2–3 and 4 mg dexamethasone every 12 hours on days 4–5. Metoclopramide (20 mg) intramuscular was used at a maximum dose of 80 mg as rescue medication to treat CINV. Patients were asked to record daily episodes of vomiting, nausea, and use of rescue medication daily through day 5.
The setting was not reported.
All patients were in active treatment.
This was a prospective design, phase II, open, nonrandomized trial.
The following were measured.
Single-dose palonosetron (250 mcg) should be considered a safe second generation 5-HT3 antagonist in the prevention of nausea and vomiting induced by HEC or MEC, irrespective of patient age.
Palonosetron provides control of CINV regardless of patient age.
Massa, E., Madeddu, C., Lusso, M.R., Gramignano, G., & Mantovani, G. (2006). Evaluation of the effectiveness of treatment with erythropoetin on anemia, cognitive functioning and functions studied by comprehensive geriatric assessment in elderly cancer patients with anemia related to cancer chemotherapy. Critical Reviews in Oncology/Hematology, 57(2), 175–182.
The study's primary aim was to examine the relationship of changes in Hgb levels following erythropoietin treatment to changes in cognitive functioning, as studied in older adult patients with cancer undergoing chemotherapy treatment. Its secondary aim was to assess the relationship of changes in Hgb levels following erythropoietin treatment to changes in functions studied in the Comprehensive Geriatric Assessment.
The study's treatment cycle was 12 weeks. For the first 2 weeks, all patients were treated with 10,000 units of erythropoietin twice daily for 6 days a week. For the following 10 weeks, participants were administered 10,000 units of erythropoietin 3 times a week. Participants were also treated with 125 mg of intravenous sodium ferric gluconate complex weekly, or more than once a week if serum iron values were below the inferior limit of normal range. All assessments, including cognition (as based on the MMSE) were completed at baseline prior to treatment with erythropoietin, and at weeks 4, 8, and 12 of treatment.
The study took place at a single-site location in Italy.
The study was a prospective single-arm trial.
The Mini-Mental State Examination (MMSE) measured global cognitive function.
The Comprehensive Geriatric Assessment (CGA) is a multidimensional, interdisciplinary diagnostic process that determines the medical, psychological, and functional capabilities of a frail elderly person. It includes
Nine participants (90%) showed significant improvement in cognitive function compared to baseline (p < 0.005), with eight of these patients also responders to erythropoietin in showing correction of anemia. All of these patients maintained improved MMSE scores after weeks 8 and 12 (p = 0.009 and 0.006). There was significant correlation between changes in Hgb levels and cognitive functioning (p = 0.049). There were no significant changes in ADL, IADL, GDS, or MNA scores as compared to baseline scores.
At baseline, the mean Hgb level was 10.3 g/dL, and 40% of patients displayed cognitive impairment (MMSE score < 24). After four weeks of treatment, Hgb levels increased significantly (p < 0.001).
The study found that treating anemic patients undergoing chemotherapy significantly improved anemia, and that this improvement was correlated with an improvement in cognitive function. However, definitive conclusions cannot be drawn from this study because of multiple limitations.
Maschmeyer, G., Beinert, T., Buchheidt, D., Cornely, O. A., Einsele, H., Heinz, W., . . . Mattiuzzi, G., (2009). Diagnosis and antimicrobial therapy of lung infiltrates in febrile neutropenic patients: guidelines of the Infectious Diseases Working Party of the German Society of Haematology and Oncology. European Journal of Cancer, 45, 2462–2472.
Patients with febrile neutropenia who developed lung infiltrates were included.
In these guidelines, prospective clinical trials involving patients with febrile neutropenia and lung infiltrates were reviewed.
Categories of Evidence Used:
Strength of Evidence:
Quality of Evidence:
Search Strategy
Databases searched were not specified.
Search keywords were lung infiltrate, treatment, aspergillosis, febrile neutropenia, and infection.
Patients receiving allogeneic hematopoietic stem cell transplantations were excluded.
Using systemic antifungals that are mold-active can improve outcomes for patients with neutropenia that has been present 10 or more days and who have developed fever and lung infiltrates (BII). The recommended pre-emptive (i.e., administration of antimicrobial agents on the basis of clinical, imaging, or laboratory findings indicative of a particular infection in patients at risk for, but without proof of, this infection) antifungal therapy is voriconazole or liposomal amphotericin B. Much of the content in this guideline is related to diagnosing and managing infections for neutropenic patients with lung infiltrates, not preventing infection, but reducing the risk of second and subsequent infections.
Specific pre-emptive therapy with voriconazole or liposomal amphotericin B in neutropenic patients can improve outcomes (BII). Patients with cancer who are neutropenic and have respiratory failure–related lung infiltrates have better outcomes if transferred to intensive care units for care, including mechanical ventilation (AII).
Conflicts of Interest: Georg Maschmeyer has been a consultant for Gilead Sciences, MSD, Pfizer, Essex (Schering-Plough), Novartis, and Sanofi-Aventis and has been on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Cephalon. Dieter Buchheidt receives grants and research support from Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough) and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough). Oliver Cornely has received grants and research support from Astellas, Basilea, Gilead Schinces, MSD, Pfizer, Essex (Schering-Plough), and Cephalon and has been a consultant for Astellas, Basilea, F2G, Gilead Sciences, MSD, Pfizer, Essex (Schering-Plough), and Cephalon and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Cephalon. Hermann Einsele has been a consultant for MSD. Werner Heinz has received grants and research support from Astellas, Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough); has been a consultant for Pfizer and Essex (Schering-Plough); and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough). Claus Peter Heussel has received research support and grants from AstraZeneca, Bayer, Bracco, General Electric, Intermun, Merck, Novartis, Pfizer, PneumRx, PulmonRx, ROX, Essex (Schering-Plough), Siemens, Roche, Wyeth, and ZLB Behring and has been a consultant for AstraZeneca, Basilea, Baxter, Bracco, Essex (Schering-Plough), Systema, Gilead Sciences, Pfizer, Perceptive, Phillips, and Siemens. Herbert Hof has been a consultant for Gilead Sciences and MSD and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough). Michael Kiehl has been a consultant for Gilead Sciences and Essex (Schering-Plough) and has served on the Speakers’ Bureau for Gilead Sciences, MSD, and Essex (Schering-Plough). Gloria Mattuizzi has received research support and grants from Astellas, MGI Pharma Inc., and Novartis.
Many of the interventions discussed were aimed at minimizing invasive fungal and other infections in patients, primarily neutropenic, who presented with lung infiltrates. The pre-emptive B-II recommendation for antifungals lacked the strength of randomized, controlled trials. The recommendation for intensive care to improve outcomes does not really address the prevention of infection.
Maschio, M., Dinapoli, L., Sperati, F., Pace, A., Fabi, A., Vidiri, A., . . . Carapella, C.M. (2012). Effect of pregabalin add-on treatment on seizure control, quality of life, and anxiety in patients with brain tumour-related epilepsy: A pilot study. Epileptic Disorders, 14, 388–397.
To evaluate the effect of pregabalin as an add-on therapy on seizure control, quality of life, and anxiety in patients with brain tumor–related epilepsy.
Pregabalin was added as a first or second add-on drug at 75 mg/day to a maximum of 600 mg/day for specific drugs (i.e., clobazan, lamorigine, levetiracetam, oxcarbazepine, phenobarbital, valproate, and topiramate).
The mean dose of pregabalin was 279 mg/day, and the mean follow-up period was 4.1 months. At the end of the follow-up, in the whole intention-to-treat population, nine patients were seizure free, 10 patients had a seizure reduction, and two patients were unchanged. There was a significant difference in the presence or absence of seizure between the baseline and the follow-up visit. There was a significant decrease in anxiety score (p = 0.002) between baseline and last available follow-up visit.
The study showed improvement in anxiety scores with pregabalins, but this is a pilot study with small sample size and a short follow-up period. Future studies with larger sample size and minimum dropout are indicated.
Larger sample size is needed to evaluate the true impact of pregabalin on anxiety among patients with brain tumor–related epilepsy. There are not many implications for nursing because the intervention is drug related.
Mar Fan, H. G., Clemons, M., Xu, W., Chemerynsky, I., Breunis, H., Braganza, S., & Tannock, I. F. (2008). A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Supportive Care in Cancer, 16, 577–583.
To investigate the effects of d-methylphenidate (d-MPH) on fatigue and cognitive function in women undergoing adjuvant chemotherapy for early breast cancer.
Patients were given 5 mg of placebo for the first chemotherapy cycle to assess for compliance and were then randomized to either d-MPH 5 mg twice daily (BID) or matched placebo. The dosage increased to 10 mg BID after one week and was taken in the morning and at noon.
The study was a randomized, controlled trial with a placebo arm.
All were measured at baseline, end of chemotherapy, and at six-month follow-up.
The difference between groups was not significant in cognitive function or fatigue.
The findings do not support the effectiveness of d-MPH at the doses given here in reducing fatigue during active treatment for breast cancer.
D-MPH cannot be suggested as an intervention to relieve cancer-related fatigue or cognitive functioning.
Marx, W.M., Teleni, L., McCarthy, A.L., Vitetta, L., McKavanagh, D., Thomson, D., & Isenring, E. (2013). Ginger (Zingiber officinale) and chemotherapy-induced nausea and vomiting: A systematic literature review. Nutrition Reviews, 71, 245-254.
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
Study exclusions were not reported.
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.
This review does not support the use of ginger for CINV prevention.
Maru, A., Gangadharan, V.P., Desai, C.J., Mohapatra, R.K., & Carides, A.D. (2013). A phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis. Indian Journal of Cancer, 50, 285–291.
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.
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.
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.