Matthews, E.E., Berger, A.M., Schmiege, S.J., Cook, P.F., McCarthy, M.S., Moore, C.M., & Aloia, M.S. (2014). Cognitive behavioral therapy for insomnia outcomes in women after primary breast cancer treatment: A randomized, controlled trial. Oncology Nursing Forum, 41, 241–253.
To examine the effect of cognitive behavioral therapy (CBT) on sleep-wake outcomes in breast cancer survivors
Women who met criteria for chronic insomnia and had completed breast cancer treatment randomly were assigned to CBT intervention or a placebo behavioral intervention. Individual, weekly CBT sessions consisted of education, stimulus control, sleep hygiene education, and cognitive therapy provided by an advanced practice nurse with specialized training. The placebo intervention was based on desensitization therapy that had been used in previous insomnia trials as a placebo treatment. For both groups, sessions 1, 3, and 6 were provided in person, and sessions 4 and 5 were provided by telephone. Sessions were audiotaped and independently reviewed by a CBT therapist to ensure fidelity. Women were evaluated at three- and six-month follow-ups.
The CBT group did not show a significantly greater improvement in sleep outcomes immediately after the intervention, but scores were significantly better by the follow-up period (p = .003). Sleep efficiency increased by more than 11% in the CBT group, compared to an increase of 6.34% in the control group (d = 0.63). Sleep latency also improved more in the CBT group (d = 0.48, p = .007). No differences between groups were found for anxiety, depression, or fatigue.
Findings show that patients receiving CBT for sleep improved several sleep outcomes compared to individuals receiving a control intervention. The intervention did not demonstrate an effect on anxiety, depression, or fatigue.
Results of this study provide evidence of a moderate and significant effect of CBT on sleep outcomes among breast cancer survivors. This adds to the body of evidence that suggests effectiveness of this approach in managing sleep-wake disturbances.
Matsuura, M., Satohisa, S., Teramoto, M., Tanaka, R., Iwasaki, M., Nishikawa, A., . . . Saito, T. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following paclitaxel and carboplatin in patients with gynecologic cancers: A randomized, multicenter, phase-II trial. The Journal of Obstetrics and Gynaecology Research, 41, 1607–1613.
To examine the proportion of patients who achieve a complete response (no emetic episodes and no rescue medication during the overall phase in each arm) with the treatment
Patients were receiving chemotherapy with carboplatin and paclitaxel for a gynecologic malignancy. All patients received a single IV dose of palonosetron (0.75 mg) on day 1 as a bolus given 30 minutes prior to chemotherapy, dexamethasone at 9.9 mg if patients were on dose-dense chemotherapy, and 20 mg for traditional carboplatin paclitaxel within 45 minutes prior to chemotherapy. Patients were then randomly assigned to two groups. Dexamethasone 8 mg was given on days 2 and 3, but no additional dexamethasone. Rescue medication was allowed. Evaluation of emetic events and nausea were measured using a diary and a 4-stage Likert-type scale. Randomization was done at a registration center with a minimization method with stratification according to institution, cancer type, age, and chemotherapy regimen.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled, non-placebo trial
In the overall period, total control was 49.1% in the three-day dexamethasone group and 37.5% of the one-day dexamethasone group. In the acute phase, it was 90.6% in the three-day group and 92.9% in the one-day group. For delayed, it was 50.9% in the three-day group and 39.3% in the one-day group. Complete control in the overall period was 67.9% in the three-day group and 58.9% in the one-day group. In the acute phase, it was 98.1% in the three-day group and 96.4% of the one-day group. When looking at the responses, there were differences with motion sickness (p = 0.037), favoring the three-day dexamethasone regimen.
The authors concluded that one day of dexamethasone is as effective as three days of dexamethasone, except in special populations, such as those with motion sickness or severe hyperemesis gravidarum. Differences in efficacy were not found in patients with other risk factors, such as alcohol use and age.
Findings not generalizable
Nurses play a key role in assessing patient risk for chemotherapy-induced nausea and vomiting. Knowing past history of morning sickness or motion sickness should clue nurses into collaborating with providers to consider three days of dexamethasone as opposed to one day.
Matsuoka, H., Makimura, C., Koyama, A., Otsuka, M., Okamoto, W., Fujisaka, Y., . . . Nakagawa, K. (2012). Pilot study of duloxetine for cancer patients with neuropathic pain non-responsive to pregabalin. Anticancer Research, 32,1805–1809.
To investigate the effect of duloxetine for cancer-related neuropathic pain in patients for whom treatment with pregabalin was unsuccessful
Data were retrospectively reviewed for patients experiencing neuropathic pain who were treated with duloxetine because pregabalin could not be administered, was ineffective, or where the dosage could not be increased due to side effects. Patients were given 20 mg of duloxetine per day, increased to 40 mg/day if needed. Pain was assessed for two weeks.
A retrospective study design was used.
Numeric rating scale for pain
Pain was reduced in 7 of the 15 patients. Baseline pain ranged from 5 to 10. After two to four weeks, pain ratings ranged from 2 to 9.
Duloxetine may be effective for relief of neuropathic pain.
Findings suggest that duloxetine may be helpful for patients with neuropathic pain as an alternative to pregabalin. This study provides weak evidence due to multiple study limitations. Further well-designed research is needed to identify the most effective management for cancer-related neuropathic pain.
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.