Vehreschild, J. J., Sieniawski, M., Reuter, S., Arenz, D., Reichert, D., Maertens, J., . . . Cornely, O. A. (2009). Efficacy of caspofungin and itraconazole as secondary antifungal prophylaxis: analysis of data from a multinational case registry. International Journal of Antimicrobial Agents, 34, 446–450.
To compare caspofungin and itraconazole as secondary prophylaxis in patients with hematological malignancies.
Physicians completed case report forms via the intranet for data collection and analysis. Physicians did not follow any specific protocol, drug selection was based upon individual discretion and timing, and dosages of medications used varied. Outcomes were assessed at the end of neutropenia.
Patients were undergoing the active antitumor treatment phase of care.
This study was observational.
Incidence of breakthrough IFD was similar in both groups of patients (31.9%–32.1%). There were no significant differences between groups in any other outcome measures. Death attributable to IFD ranged from 3.6% to 4.3%. Aspergillosis was the most frequent infection, followed by candidiasis. Overall mortality was 16%.
No differences were found in efficacy between these two medications; however, no conclusions could be drawn due to multiple study limitations and significant differences between patient groups in the sample.
*Substantial variability in patient characteristics that would influence findings, variability in methods of treatment, other measures used for infection prevention, etc.
This study provided no evidence to differentiate the efficacy between these two medications for secondary antifungal prophylaxis.
Rodriguez Vega, B., Palao, A., Torres, G., Hospital, A., Benito, G., Perez, E., . . . Bayon, C. (2011). Combined therapy versus usual care for the treatment of depression in oncologic patients: A randomized controlled trial. Psycho-Oncology, 20(9), 943–952.
To compare the effects—on quality of life and symptoms of depression—of an intervention consisting of a psychotherapeutic intervention, narrative therapy, plus escitalopram to the effects of usual care plus escitalopram
The initial sample was composed of 1,026 patients, between March 2006 and June 2008, with a diagnosis of breast, lung, or colorectal nonmetastatic cancer, three months after cancer diagnosis and no later than two years after diagnosis. Investigators used the Hospital and Anxiety Depression Scale (HADS) to screen participants for depression. A total of 150 had depressive disorder according to DSM-IV-TR criteria. The study contained 72 participants, 33 in usual care and 39 in combined care. Escitalopram was administered on a fixed-flexible schedule in both groups, beginning with 10 mg per day and adjusted up to 20 mg per day by week 8. A minimum of six months treatment was established for both groups. The narrative intervention was carried out individually during 12 weekly sessions, each 45 minutes long, and was guided by a treatment manual. Of the sessions, 10% were videotaped to help ensure adherence. Usual care consisted of oncologist-adminstered antidepressant. The oncologist followed a protocol and reported side effects of the medication. The follow-up of patients in the usual-care group was similar to that of patients in the treatment group. Investigators assessed depression-related outcome at weeks 12 and 24.
Two-center randomized controlled trial
Demographic variables did not differ significantly between the two groups. Gender and age were unbalanced because of cancer types. At 12 and 24 weeks, the combined-therapy group showed significantly greater improvement in all the dimensions of function (p < 0.01), pain scale (p = 0.02), global health (p = 0.02), and global quality of life (p = 0.007). Between groups there were no statistically significant differences in symptoms of depression. From week 12 to 24, study retention was higher in the combined-treatment group (p = 0.01).
Using combined therapy for major depression in patients with cancer results in significant improvements in quality of life but does not result in a significant reduction in symptoms of depression. Narrative therapy is an integrative intervention designed to address components of critical importance in patients with depression. The therapy may have a positive impact on patient’s fears and worries about medication interactions and side effects.
The interventions proved to be acceptable to patients. The intervention shows good potential for dissemination, is relatively easy to implement, and improved compliance. The intervention may be a low-cost means of improving the quality of life of patients with cancer.
Vayne-Bossert, P., Escher, M., de Vautibault, C., Dulguerov, P., Allal, A., Desmeules, J., . . . Pautex, S. (2010). Effect of topical morphine (mouthwash) on oral pain due to chemotherapy- and/or radiotherapy-induced mucositis: A randomized double-blinded study. Journal of Palliative Medicine, 13(2), 125–128.
To determine if a mouthwash containing morphine decreases oral pain associated with chemotherapy- or radiotherapy-induced mucositis
Subjects were randomized to two groups. One used 2% morphine solution. The other used a placebo, a quinine solution. Both groups used the specified solution six times daily, holding the solution in the mouth for 2 minutes at each application. After three days patients crossed over to the alternate treatment. Patients kept daily diaries and rated oral pain before and one hour after the mouthwash. The study lasted six days.
Phase of care: active treatment
Randomized double-blind crossover study
The study used a 10 cm visual analog scale (VAS), to rate pain.
ANOVA suggested a difference over time between placebo and morphine, but authors noted no significant differences in pain between mouthwashes on the same or different days. Not all patients adhered to prescribed frequency of use. Authors noted no adverse events.
Study results did not support the use of morphine mouthwash as a treatment for the pain of oral mucositis.
This study was too small to demonstrate the effects of a morphine-containing mouthwash on mucositis-associated oral pain.
Vavassis, P., Gelinas, M., Chabot Tr, J., & Nguyen-Tân, P. F. (2008). Phase 2 study of silver leaf dressing for treatment of radiation-induced dermatitis in patients receiving radiotherapy to the head and neck. Journal of Otolaryngology-Head and Neck Surgery, 37, 124–129.
To investigate the effectiveness of silver leaf dressings in treating radiation-induced dermatitis compared with the current standard of care (silver sulfadiazine).
Patients presenting with grade 2 or greater skin toxicity within radiation portals were offered the topical treatment of silver sulfadiazine (application three times daily and removed prior to daily radiation) and silver leaf dressing worn constantly (removed only for radiation treatments).
Each patient applied silver leaf dressing on one side of the neck and silver sulfadiazine on the other.
Silver leaf dressing and silver sulfadiazine were each assigned randomly to each side of the patient’s neck.
The study used a quasiexperimental design; patients were used as their own controls.
Silver leaf dressing does not appear to be superior to standard treatment for radiation-induced dermatitis when the RTOG grading system is used.
Vargas, S., Antoni, M.H., Carver, C.S., Lechner, S.C., Wohlgemuth, W., Llabre, M., . . . Derhagopian, R.P. (2013). Sleep quality and fatigue after a stress management intervention for women with early-stage breast cancer in Southern Florida. International Journal of Behavioral Medicine. Retrieved from http://link.springer.com/article/10.1007%2Fs12529-013-9374-2
10-week CBSM
No statistical differences in PSQI total scores or changes in fatigue intensity between groups. Changes in sleep quality were associated with change in fatigue.
CBSM may have some positive effects on elements of sleep quality and fatigue. Data support an association between sleep quality and fatigue (fatigue-related daytime interference).
Consider evaluation of sleep disturbance in patients experiencing fatigue.
Vargas-Bermudez, A., Cardenal, F., & Porta-Sales, J. (2015). Opioids for the management of dyspnea in cancer patients: Evidence of the last 15 years—A systematic review. Journal of Pain and Palliative Care Pharmacotherapy, 29, 341–352.
STUDY PURPOSE: To review the evidence for opioids in the treatment of dyspnea in patients with cancer
TYPE OF STUDY: Systematic review
PHASE OF CARE: Not specified or not applicable
APPLICATIONS: Palliative care
Overall, opioids were seen to be beneficial in reducing dyspnea.
This review adds to the body of evidence regarding the efficacy of opioids for the management of dyspnea in patients with cancer. Morphine is the most frequently studied opioid.
Vardakas, K.Z., Michalopoulos, A., & Falagas, M.E. (2005). Fluconazole versus itraconazole for antifungal prophylaxis in neutropenic patients with haematological malignancies: A meta-analysis of randomised-controlled trials. British Journal of Haematology, 131, 22–28.
The study aim was to evaluate the comparative safety and effectiveness of fluconazole versus itraconazole as primary prophylaxis in neutropenic patients with cancer. The main outcomes of the study were withdrawals from the studies because of adverse effects, documented fungal infections, invasive fungal infections, differentiation between mold and yeast invasive infections, and overall mortality. Secondary outcomes were total fungal infections, suspected fungal infections, superficial fungal infections, and mortality attributed by the authors of each randomized, controlled trial (RCT) to fungal infections.
PubMed (until March 2005), Current Contents Connect, and the Cochrane Central Register for Controlled Trials databases were searched, as were the references from relevant articles, including review papers, to identify relevant RCTs. Two independent reviewers performed literature searches and examined the identified relevant RCTs for evaluation of data on toxicity and effectiveness.
Search terms included prophylaxis, prevention, antifungal, azoles, fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole, neutropenia, granulocytopenia, bone marrow transplantation (BMT) and stem cell transplantation (SCT)
A study was considered eligible if it was an RCT, it compared the effectiveness of prophylactic fluconazole with prophylactic itraconazole in neutropenic patients, and it assessed toxicity, effectiveness of azoles, or mortality. Concurrent use of topical antifungal agents, such as nystatin or amphotericin B, were permitted. The administration of IV amphotericin B was not permitted unless an invasive fungal infection was documented or suspected.
RCTs comparing the effectiveness of fluconazole or itraconazole with placebo or no treatment or polyenes were excluded. RCTs comparing other azoles also were excluded.
Seven refernece were retreived.
Statistical analyses were performed using meta-analyst software. The heterogeneity between RCTs was assessed by using a chi-square test; a p value lower than 0.1 was defined to note statistical significance in the analysis of heterogeneity. Publication bias was assessed by the funnel plot method using Egger’s test. Pooled odds ratios (OR) and 95% confidence intervals (CIs) for all primary and secondary outcomes were calculated, by using both the Mantel-Haenszel fixed effects and the DerSimonian-Laird random effects models. Results from the fixed effects model are presented only when no heterogeneity between RCTs was observed; otherwise, results from the random effects model are presented. A methodologic quality assessment of each trial was performed. Details of randomisation, the use of double blinding, handling of withdrawals, concealment of allocation, and generation of allocation sequences were awarded one point, for a maximum achievable score of five points. High-quality RCTs scored more than two points, while low-quality RCTs scored two or less points, according to the reported methodology.
Active treatment
No statistically significant differences were noted between prophylaxis with fluconazole and itraconazole regarding documented fungal infections (OR = 1.51, 95% CI [0.97, 2.35], five RCTs), invasive fungal infections (OR = 1.44, 95% CI [0.96, 2.17], four RCTs), development of mold infections (OR = 1.36, 95% CI [0.83, 2.24], four RCTs), development of yeast infections (OR = 2.28, 95% CI [0.92, 5.666], three RCTs), and all-cause mortality (OR = 0.89, 95% CI [0.63, 1.24], five RCTs).
Prophylactic use of fluconazole resulted in significantly more fungal infections (OR = 1.62, 95% CI [1.06, 2.48], four RCTs). However, no statistical difference was noted between fluconazole and itraconazole in the development of suspected fungal infections (OR = 1.23, 95% CI [0.74, 2.02], four RCTs), superficial fungal infections (OR = 1.49, 95% CI [0.67, 3.31], three RCTs), and mortality attributed by the authors to fungal infections (OR = 1.3, 95% CI [0.75, 2.25], five RCTs). Significantly fewer patients were withdrawn from the studies due to the development of adverse effects with fluconazole prophylaxis when compared with itraconazole (OR = 0.27, 95% CI [0.18, 0.41], five RCTs). Gastrointestinal complaints were the most common reason for withdrawal from the studies because of adverse effects. The main reason for withdrawal from the RCTs because of an adverse effect was hepatic or renal dysfunction.
Fluconazole was associated with slightly more fungal infections, but there was no difference in mortality between fluconazole and itraconazole, and fluconazole was associated with fewer adverse effects.
Fluconazole and itraconazole are both effective for primary antifungal prophylaxis.
van Weert, E., Hoekstra-Weebers, J., Otter, R., Postema, K., Sanderman, R., & van der Schans, C. (2006). Cancer-related fatigue: predictors and effects of rehabilitation. Oncologist, 11, 184–196.
The 15-week, multidimensional rehabilitation program included aerobic bicycle training plus general muscle force training, supervised sports sessions, psychoeducational sessions, and informational classes.
The study used a pre-/posttest design with measures before and after completion of the program. No control group was used.
Vandecasteele, K., Ost, P., Oosterlinck, W., Fonteyne, V., Neve, W. D., & Meerleer, G. D. (2012). Evaluation of the efficacy and safety of salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation. Phytotherapy Research: PTR, 26(2), 208-213.
The study measured the efficacy and side effects of treatment with salvia officinalis for hot flashes in men with prostate cancer treated with androgen deprivation.
Salvia officinalis extract was provided in 150 mg tablets to be taken 3 times daily. Thujone was confirmed to be absent from the product. Patients were to complete a hot flash diary daily. Patients were seen in clinic every 1-2 weeks for 10 weeks at which time they turned in diaries, received a new supply of the salvia tablets, and had a clinical examination and bloodwork.
Nine men, with a mean age of 68 years (range 62-73), were enrolled. All had prostate cancer, were receiving androgen deprivation therapy, and were experiencing hot flashes. Patients were excluded if they were unlikely to comply with the protocol or had an uncooperative attitude
PHASE OF CARE: Transition phase after active treatment
This was a quasiexperimental feasibility study.
Salvia use reduced hot flashes from a pretreatment mean Moyad score of 112 to a posttreatment mean of 54 (p = .002). There was a decrease in LH and FSH levels. There were no significant effects on testosterone, blood pressure, or cholesterol levels. Hot flash reduction appeared within the first 3 weeks. After this time, Moyad scores were essentially stable. Sub-group analysis of 8 patients who had at least grade 2 hot flashes at baseline showed a substantial variability of responses. One patient developed a skin rash that may have been associated with the use of salvia
Salvia officinalis was associated with reduction in hot flash scores and minimal side effects in this small pilot study.
This study provides little information to support use of salvia officinalis for hot flashes in these patients. The sample size is too small and study design insufficient to examine potential efficacy and the actual side effect profile of this intervention. Larger, well-designed clinical trials are needed.
van Dalen, E.C., Mank, A., Leclercq, E., Mulder, R.L., Davies, M., Kersten, M.J., & van de Wetering, M.D. (2012). Low bacterial diet versus control diet to prevent infection in cancer patients treated with chemotherapy causing episodes of neutropenia. Cochrane Database of Systematic Reviews, 9, CD006247.
To determine the efficacy of a low bacterial diet (LBD) versus a control diet in preventing the occurrence of infection and reducing related mortality in patients with cancer receiving immunosuppressive chemotherapy.
Databases searched were the Cochrane Central Register (CENTRAL), DARE, PubMed, EMBASE, and CINAHL, as were conference proceedings from multiple professional groups.
Included in the study were patients with cancer receiving chemotherapy causing episodes of neutropenia, use of an LBD versus a control diet, with an LBD defined as any diet intended to reduce the ingestion of bacterial and fungal contaminants by exclusion of uncooked fruits and vegetables, cold cuts, undercooked eggs and meat, unsterilized water, unpasteurized milk products, and soft cheeses. The control diet was any other diet.
Children younger than 1 year were excluded from the study.
Six hundred nineteen total references were retrieved.
Risk of study bias was evaluated using the Cochrane Handbook for Systematic Reviews of Interventions.
Included studies had different definitions of infection rate and different outcomes measured and defined. Blinding and selection bias were problems in the study design, and only one study provided explicit data on the use of empirical antibiotics and antimycotics. Data could not be pooled for meta-analysis. In all three studies, there was no significant difference in outcomes between groups.
There is currently no strong evidence demonstrating the need or effectiveness of LBDs, and due to differing outcome measures, diets used and cointerventions for prophylaxis pooling of results was not possible. No firm conclusions can be drawn, and no recommendations for clinical practice are made.
The results suggest that no firm conclusions can be made about the usefulness of an LBD and that there is no strong evidence to show the effect. Additional well-designed research in this area would be helpful.