Chaftari, A. M., Hachem, R. Y., Ramos, E., Kassis, C., Campo, M., Jiang, Y., . . . Raad, I. I. (2012). Comparison of posaconazole versus weekly amphotericin B lipid complex for the prevention of invasive fungal infections in hematopoietic stem-cell transplantation. Transplantation, 94, 302–308.
To evaluate once weekly intravenous (IV) amphotericin B lipid complex (ABLC) given at a dose of 7.5 mg/kg as an alternative to posaconazole oral suspension (200 mg three times per day with food) for antifungal prophylaxis in hematopoietic stem cell transplantation (HSCT) recipients.
Patients were randomized to either the ABLC arm (N = 22) or posaconazole arm (N = 24). All patients were at risk for invasive fungal infection due to intensive chemotherapy for treatment of acute leukemia or lymphoma with a prolonged period of neutropenia expected or they were in the early phase after allogeneic HSCT. Patients were given ABLC 7.5 mg/kg once weekly over four to six hours or posaconazole oral suspension 200 mg three times daily with a high fat content meal for the duration of neutropenia. The study evaluated adverse events through the end of prophylaxis and up to two weeks thereafter. Study endpoints were the incidence of invasive fungal infections and drug-related toxicities. ABLC was discontinued if the creatinine level increased to two times the baseline or greater.
Patients were undergoing the active antitumor treatment phase of care.
This was a prospective, randomized, open-label, single-institution study.
Toxicities were measured using grades 1–4 based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Patient tolerability of the drug was also measured. Compliance to oral posaconazole and fatty meal intake were measured based on patient diary entries. Infusion-related toxicity (ABLC) was reported and recorded by the infusion nurse. Creatinine clearance for ABLC administration was calculated using Cockcroft-Gault formula. All patients were evaluated for clinical signs and symptoms and radiologic and mycological findings suggestive of invasive fungal infection during the study period (the duration of neutropenia).
Both groups were comparable for the rate of occurrence of neutropenia and its duration, steroid usage, tacrolimus therapy, and tacrolimus blood levels during prophylaxis. Both groups were comparable for the development of graft-versus-host disease. Nineteen patients in the ABLC arm and 20 patients in the posaconazole arm developed adverse events, including 18 drug-related events in the ABLC arm (nephrotoxicity, hypokalemia, hypomagnesemia, fever, chills, and headache) and 17 in the posaconazole arm (increase in liver function tests, hypokalemia, hypomagnesemia, nausea, vomiting, and diarrhea). The discontinuation rate from adverse events was 15 of 19 in the ABLC arm versus 8 of 20 in the posaconazole arm (p = 0.009). Lower creatinine clearance was noted in the ABLC arm (p = 0.006). Patients receiving ABLC experienced more chills (p = 0.04). Median duration of prophylaxis was significantly longer in the posaconazole arm (p = 0.04). One patient in the ABLC arm developed an invasive fungal infection compared to none in the posaconazole arm. The study was stopped early because the interim data analysis suggested that there was more than a 70% chance that the nephrotoxicity rate of the ABLC group was greater than 50%.
High weekly doses of IV ABLC may not be appropriate antifungal prophylaxis in allogeneic HSCT recipients due to potential nephrotoxicity, although it could be useful in less complex patients, such as those receiving therapy for leukemia (non-HSCT). Oral posaconazole can have erratic absorption, but it was shown to be safer than weekly ABLC in this study. Better prophylaxis is needed in patients who cannot tolerate oral medications.
* The findings are generalizable only to HSCT/hematologic malignancy patients, and only those with hematologic malignancies were included in the sample.
Because posaconazole is such an effective antifungal agent for prophylaxis (reinforced here), nurses must be vigilant in patient education. Patients must be given instructions to take the drug during or within 20 minutes of a full meal (preferably with high fat content) or liquid nutritional supplement or with an acidic carbonated beverage (i.e., ginger ale). There are many restrictions, and patient education is key to taking this drug and ensuring its efficacy.
Chaberny, I. F., Ruseva, E., Sohr, D., Buchholz, S., Ganser, A., Mattner, F., & Gastmeier, P. (2009). Surveillance with successful reduction of central line-associated bloodstream infections among neutropenic patients with hematologic or oncologic malignancies. Annals of Hematology, 88, 907–912.
The purpose of the study was to introduce prospective surveillance for nosocomial infections to improve prevention measures and reduce central line-associated blood stream infections (CLABSIs) in patients with hematologic malignancies.
Surveillance was performed for 18 months, after which the incidence rates for CLABSIs were calculated. Ward staff were then presented with the data and trained on measures to reduce CLABSIs according to national and international guidelines. During this time, they also implemented the use of chlorhexidine silver sufadiazine-coated catheters. Surveillance was then conducted for an additional 18 months.
Active treatment
This was a prospective surveillance (pre/post design) study.
During the first study period (prior to intervention), CLABSIs occurred at a rate of 24.3 per 1,000 neutropenic days. This rate was notably higher than the median of the comparator group (17.7 per 1,000 neutropenic days) during the same study period. Following intervention, the CLABSI incidence rate dropped to 16.2 per 1,000 neutropenic days, which was below the median of the comparator group (17.7 per 1,000 neutropenic days). The reduction was significant (odds ratio = 0.58; 95% confidence interal [0.34-0.99]).
Strict adherence to hand hygiene and other preventive guidelines when handling central lines in neutropenic patients can have a positive impact on lowering the incidence of CLABSIs.
As part of the intervention, staff education included demonstrating that CLABSI incidence rates at the facility were higher than at comparable centers. This approach provides motivation for changes in nursing practice.
Cerrone, R., Giani, L., Galbiati, B., Messina, G., Casiraghi, M., Proserpio, E., . . . Gardani, G. (2008). Efficacy of HT 7 point acupressure stimulation in the treatment of insomnia in cancer patients and in patients suffering from disorders other than cancer. Minerva Medica, 99, 535–537.
To evaluate the efficacy of HT 7 point acupressure for the treatment of insomnia in patients with cancer as compared to patients with medical illnesses other than cancer.
Patients were included if they reported sleeping disorders lasting at least three months, lacked response to benzodiazepine drugs, reported no chronic pain, and had no current drug therapy inhibiting the induction of sleep. Acupressure devices (H7 insomnia control, Consultream s.as., Como, Italy) were applied to both wrists starting at 10 pm each night for at least two weeks.
Not specified
The phase of care was not stated.
The study was a prospective, single-group trial.
Sleep quality improved in the first 10 days for 15 of 25 patients (60%). A greater number of oncology patients had improvements in sleep quality (79%) than those with other medical illnesses (36%), but this did not represent a statistical difference (no test statistic reported by the authors).
HT 7 improved insomnia in patients with cancer and other medical illnesses.
Further information is needed to accurately draw conclusions regarding the usefulness of acupressure in oncology patients.
Cerchietti, L.C., Navigante, A.H., Lutteral, M.A., Castro, M.A., Kirchuck, R., Bonomi, M., … Uchima, P. (2006). Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer. International Journal of Radiation Oncology, Biology, Physics, 65, 1330–1337.
Patients were randomized to receive IV L-alanyl-L-gluatime 0.3 g/kg (30 infusions in 5 patients) or 0.4 mg/kg (25 infusions in 5 patients), administered at a rate of 0.1 g/kg body weight/h. The principal endpoint was incidence of mucositis (mean of three highest scores by Objective Mucositis Assessment Score (OMAS) and highest grade on World Health Organization [WHO] scale).
The study used a two-step design. Patients were randomized first to different doses of the glutamine intervention, then to placebo (double-blind).
OMAS and WHO grading scale were used.
Measurement using both mucositis scales indicated a significant difference in intensity of mucositis.
Cerchietti, L. C., Navigante, A. H., Peluffo, G. D., Diament, M. J., Stillitani, I., Klein, S. A., & Cabalar, M. E. (2004). Effects of celecoxib, medroxyprogesterone, and dietary intervention on systemic syndromes in patients with advanced lung adenocarcinoma: a pilot study. Journal of Pain and Symptom Management, 27, 85–95.
Systemic-immune metabolic syndrome (SIMS) implies dysregulation of psychoneuroimmunoendocrine homeostasis, resulting in cachexia, anorexia, chronic nausea, early satiety, fatigue, tumor fever, cognitive changes, and superinfections (i.e., increased cytokines may increase cachexia-anorexia syndrome [CAS] and mediate anorexia).
The study included 15 adult outpatients with stage IIIb or IV lung adenocarcinoma.
Patients were included if they
The study was conducted in a community outpatient setting in Argentina.
The study used a pilot, open-label, uncontrolled convenience sample design.
Weekly measurements included
Cost of medications, polymeric diet, and cost of cytokine measurements should be considered.
Cepeda, M.S., Chapman, C.R., Miranda, N., Sanchez, R., Rodriguez, C.H., Restrepo, A.E., . . . Carr, D.B. (2008). Emotional disclosure through patient narrative may improve pain and well-being: Results of a randomized controlled trial in patients with cancer pain. Journal of Pain and Symptom Management, 35, 623–631.
To determine if a structured approach using patient narrative in patients with advanced cancer decreases pain and improves sense of well-being
Patients were randomized into one of three groups: (1) narrative group, (2) questionnaire group, or (3) control group. Patients in the narrative group were asked to write about how cancer affected their lives, calling upon their deepest thoughts, feeling, and fears, and to write for at least 20 minutes once a week. Patients in the questionnaire group were asked to complete a pain questionnaire as an attentional control. Patients in the control group were asked to attend weekly medical follow-up visits and receive usual care. All patients were seen weekly in the clinic for eight weeks. Three weeks after randomization, research personnel called patients to remind them about completing narratives, filling out the questionnaire, and coming to the office for follow-up. Research personnel who collected data were blinded to group assignment. Patients rated their average pain intensity during the prior week in clinic visits. Investigators rated emotional content of the narratives.
The study was a randomized, single-blinded, controlled trial.
There were no differences between groups in outcomes measured. More than half (53%) of patients in the narrative group completed narratives as requested, 86% of patients in the questionnaire group completed the questionnaire, and 90% of patients in the control group kept all clinic appointments. Twenty patients did not demonstrate any emotional disclosure in narratives. Five patients had strong emotional content of narratives, and these patients had lower pain intensity scores.
Participation in writing narratives as structured in this study did not have any impact on pain or well-being. Only half of the patients fully participated in the narrative writing as designed.
Study findings suggest that having patients write narratives for emotional disclosure to reduce pain is not effective. The apparent lack of actual emotional content in the majority of narratives reviewed in this study suggests that patients need assistance to identify and disclose these aspects of their experience. It is not clear whether patients may have concerns about privacy in terms of what content they provided in this research.
Cepeda, M.S., Carr, D.B., Lau, J., & Alvarez, H. (2010). Music for pain relief. Cochrane Database of Systematic Reviews 2010(8).
To evaluate the effect of listening to music on acute or chronic cancer pain; to relate the effect of listening to music on analgesic requirements
Music has limited utility in clinical practice for pain reduction: A music intervention was associated with minimal reduction in pain intensity. A music intervention was associated with a small reduction in opioid use for the treatment of acute pain. The reduction was smaller than that associated with the use of an NSAID or paracetamol.
The analysis provided little support for the effectiveness of music in the reduction of pain: The size of effects is small, and their clinical relevance is unclear. On the other hand, the analysis revealed no negative effects from the music intervention. Clinicians should be aware of the limited utility of music for pain management. Most of the studies in the analysis did not include patients with cancer; however, the highest effect sizes were in the setting of chronic pain, so a music intervention may be relevant to patients with cancer. Use of music along with other nonpharmaceutical and maximal pharmaceutical pain management may be helpful for some patients. Further research in this area would be useful.
Centeno, C., Sanz, A., Cuervo, M.A., Ramos, D., Hernansanz, S., Gonzalez, J., . . . Pascual, A. (2012). Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients. BMJ Supportive and Palliative Care, 2, 328–333.
To study the efficacy of methylphenidate for relief of depressive symptoms in patients with advanced cancer.
Patients who indicated some depressive symptoms from screening were randomized to receive methylphenidate ranging from 10-45 mg daily for 28 days. Doses were adjusted according to individual patient need and toxicity evaluation according to a protocol established for the study. Patient visits and evaluation occurred at days 0, 2, 7, 14, 21, and 28 either in the clinic or the patients’ homes. Patients who completed at least eight days of involvement were included in intent-to-treat analysis using the last measure carried forward.
Methylphenidate administration was not significantly better than placebo for symptoms of depression or anxiety and was associated with more adverse events. The evidence regarding efficacy of methylphenidate is inconclusive.
This study sample was not large enough to enable firm conclusions from this individual study; however, findings did not show a benefit of methylphenidate and showed more adverse events that may be associated with methylphenidate. These results are not supportive for use of methylphenidate in the management of anxiety and depressive symptoms in patients with advanced cancer.
Centeno, C., & Vara, F. (2005). Intermittent subcutaneous methadone administration in the management of cancer pain. Journal of Pain and Palliative Care Pharmacotherapy, 19(2), 7–12.
To study the dose, level of pain, and toxicity symptoms associated with intermittent subcutaneous methadone injections used to treat cancer pain
Over seven days, patients whose pain was well controlled with oral methadone received subcutaneous methadone via a butterfly needle that was used exclusively for methadone. The conversion ratio, oral methadone to subcutaneous methadone, was 1:1.
Two of 10 patients withdrew because of nonpainful irritation at the injection site. Compared to the methadone doses other patients were taking, these two patients took significantly higher doses: 40–45 mg, either every 8 hours or every 12 hours. All other patients’ doses were 5–25 mg, either every 8 hours or every 12 hours. Eight patients completed the study over seven days. Pain levels went from 3.3 to 3.5 on a 0–10 scale.
Intermittent subcutaneous methadone administration seems to be a useful alternative when oral administration is not feasible.
The study had a small sample size.
The conversion ratio, oral to subcutaneous methadone, was 1:1. This is not the currently recommended conversion ratio, though patients in the study experienced no increase in toxicity as the result of the 1:1 conversion. However, the duration of the study was only seven days; a longer duration may have resulted in toxicity effects. Higher doses caused local irritation. At even higher doses, clinicians may have to consider other strategies, such as adding dexamethasone to the infusion. If a patient is unable to take oral methadone, alternatives other than subcutaneous methadone—transdermal or buccal administration—are available.
Censabella, S., Claes, S., Robijns, J., Bulens, P., & Mebis, J. (2016). Photobiomodulation for the management of radiation dermatitis: The DERMIS trial, a pilot study of MLS(®) laser therapy in breast cancer patients. Supportive Care in Cancer, 24, 3925–3933.
To assess the effects of Multiwave Lock System low-level laser therapy in the management of acute radiation dermatitis
All patients received standard skin care including hydroactive colloid gel thre times daily throughout radiation therapy and self-adhesive silicone foam dressing for dry or moist desquamation. Those in the laser therapy group also received six sessions twice a week starting from fraction 20 of radiation. Results from the laser group were compared to that of a historical control group who had only usual care.
PHASE OF CARE: Active antitumor treatment
Prospective, quasiexperimental with historical control comparison
RTOG scores in the control group increased over time but remained stable in the laser group. The difference between groups was significant (p < 0.005). There were no cases of greater than grade 2 skin toxicity. Analysis of change in RISRA scores showed improvement in subjective scores in the laser group (p = 0.023) and less score increase overall in the laser group (p < 0.03).
This type of low-level laser therapy was shown to be beneficial in reducing the severity of radiodermatitis among women being treated for breast cancer.
The use of low-level laser therapy may have some benefit for the management of radiodermatitis. The promising findings from this study warrant additional well designed research.