Mangili, G., Petrone, M., Gentile, C., De Marzi, P., Vigano, R., & Rabaiotti, E. (2008). Prevention strategies in palmar-plantar erythrodysesthesia onset: The role of regional cooling. Gynecologic Oncology, 108, 332–335.
To evaluate the effectiveness of strategies to prevent palmar-plantar erythrodysesthesia (PPE) incidence, including regional cooling, behavioral rules, and lower-dose pegylated liposomal doxorubicin (PLD), in patients with gynecologic malignancies.
PLD doses ranged from 30 to 50 mg/m2 every 21 to 28 days. All patients received premedication with oral dexamethasone 8 mg (12 hours before PLD) and pyridoxine 300 mg PO daily. All patients were advised to follow strict behavioral rules: keep skin well hydrated, avoid sunlight, minimize trauma to the hands and feet, avoid contact with warm water, and avoid hot foods and liquids. Patients who were enrolled from 2001 to December 2003 were in the non–regional cooling group (n = 25), whereas patients who were enrolled from January 2004 to 2006 were in the regional cooling group (n = 28). Patients received regional cooling (application of ice packs around wrists and ankles) and icicles during PLD infusion.
Obstetrical/Gynecological Department at San Raffaele Hospital in Milan, Italy
This was a prospective, observational, single-center, nonrandomized study.
Skin toxicity was graded according to National Cancer Institute (NCI) and Gynecologic Oncology Group (GOG) criteria.
The incidence of PPE was significantly higher in the non–regional cooling group (n = 9, 36%) compared to the regional cooling group (n = 2, 7%; p = 0.0097).
Multivariant analysis revealed the use of a regional cooling protocol and lower PLD dosage were significant factors in reducing the onset and incidence of PPE. The authors estimated the probability of developing PPE in a patient who receives 30 to 35 mg/m2 of PLD and follows the regional cooling protocol is 1.42%. Conversely, a patient who does not adapt this regional cooling protocol and receives 40 to 50 mg/m2 of PLD every three weeks has a 60.41% estimated probability of developing PPE.
Mangili, G., Petrone, M., Gentile, C., De Marzi, P., Vigano, R., & Rabaiotti, E. (2008). Prevention strategies in palmar-plantar erythrodysesthesia onset: The role of regional cooling. Gynecologic Oncology, 108, 332–335.
To evaluate the effectiveness of strategies to prevent palmar-plantar erythrodysesthesia (PPE) incidence, including regional cooling, behavioral rules, and lower-dose pegylated liposomal doxorubicin (PLD), in patients with gynecologic malignancies.
PLD doses ranged from 30 to 50 mg/m2 every 21 to 28 days. All patients received premedication with oral dexamethasone 8 mg (12 hours before PLD) and pyridoxine 300 mg PO daily. All patients were advised to follow strict behavioral rules: keep skin well hydrated, avoid sunlight, minimize trauma to the hands and feet, avoid contact with warm water, and avoid hot foods and liquids. Patients who were enrolled from 2001 to December 2003 were in the non–regional cooling group (n = 25), whereas patients who were enrolled from January 2004 to 2006 were in the regional cooling group (n = 28). Patients received regional cooling (application of ice packs around wrists and ankles) and icicles during PLD infusion.
Obstetrical/Gynecological Department at San Raffaele Hospital in Milan, Italy
This was a prospective, observational, single-center, nonrandomized study.
Skin toxicity was graded according to National Cancer Institute (NCI) and Gynecologic Oncology Group (GOG) criteria.
The incidence of PPE was significantly higher in the non–regional cooling group (n = 9, 36%) compared to the regional cooling group (n = 2, 7%; p = 0.0097).
Multivariant analysis revealed the use of a regional cooling protocol and lower PLD dosage were significant factors in reducing the onset and incidence of PPE. The authors estimated the probability of developing PPE in a patient who receives 30 to 35 mg/m2 of PLD and follows the regional cooling protocol is 1.42%. Conversely, a patient who does not adapt this regional cooling protocol and receives 40 to 50 mg/m2 of PLD every three weeks has a 60.41% estimated probability of developing PPE.
Mandhaniya, S., Swaroop, C., Thulkar, S., Vishnubhatla, S., Kabra, S.K., Xess, I., & Bakhshi, S. (2011). Oral voriconazole versus intravenous low dose amphotericin B for primary antifungal prophylaxis in pediatric acute leukemia induction: A prospective, randomized, clinical study. Journal of Pediatric Hematology/Oncology, 33, e333–e341.
The purpose of the study was to compare the efficacy and toxicity of oral voriconazole to IV low-dose amphotericin B in pediatric patients with acute leukemia.
Oral variconazole was administered at a dose of 6 mg/kg per dose for initial two doses followed by 4 mg/kg per dose twice daily one hour before meals. Low-dose IV amphotericin B was administered at a dose of 0.5 mg/kg per day three times a week. Before administration of amphotericin B all patients received diphehydramine IV and oral paracetamol as premedication and saline hydration post infusion. Systemic antifungals were not allowed for use before patients underwent the trial. Complete blood count, liver function tests, and renal function tests were done at least twice weekly until seven days after completion or failure.
Randomized, non-stratified, open-label, single-institution pilot study.
The overall probable, proven, and possible fungal infections were 5% in the study. In the voriconazole arm, 28% had failure of prophylaxis compared to 34% failure rate in the amphotericin B arm. No differences were noted between groups in proven, probable, and possible fungal infections. Those receiving the voriconazole had significantly less toxicity, with 6% of patients in variconazole arm having any serious adverse event (SAE) compared to 31% in the amphotericin B arm (hypokalemia) (p < 0.001). With the amphotericin B arm, 50% had infusion reactions.
Oral voriconazole seemed to be comparable with amphotericin B, with less toxicity and more convenience.
Potential increased need for patient and caregiver education regarding oral medication administration. Continued research in comparable efficacy of antifungal agents will be helpful in order to select effective agents that are least toxic, practical, and cost effective.
Mancuso, A., Migliorino, M., De Santis, S., Saponiero, A., & De Marinis, F. (2006). Correlation between anemia and functional/cognitive capacity in elderly lung cancer patients treated with chemotherapy. Annals of Oncology, 17, 146–150.
To investigate whether any association exists between hemoglobin (Hgb) levels and functional capacity, cognitive impairment, and comorbidities in older adult patients with lung cancer who were treated with chemotherapy
Patients were evaluated prior to the initiation of chemotherapy (baseline) and before each subsequent cycle (after 21 days) for quality of life, mental capacity, functional status, depression, and comorbidities.
A descriptive prospective study design was used.
Hgb level was significantly correlated with cognitive function at baseline prior to chemotherapy (r = 0.61, p < 0.002), as well as after one (r = 0.48, p < 0.002) and two cycles (r = 0.60, p < 0.002) of chemotherapy. A significant association was discovered between the change in Hgb levels and cognitive capacity as defined by the MMSE after the first (r = 0.48, p < 0.002) and second cycle (r = 0.60, p < 0.002) of chemotherapy. Significant associations were found between Hgb levels and VAS, CIRS-G, ADL, IADL assessments, and GDS at baseline and GDS at baseline and after one and two cycles of chemotherapy (p < 0.05). The strength of these correlations varied. Change in Hgb level was associated with the change in all above parameters with the exception of IADL, which was not significant.
Although the study was not designed to demonstrate a clinical benefit of erythropoietin on cognitive function during treatment, the authors noted that 14 patients who received erythropoietin during the first two cycles of chemotherapy experienced increases in the Hgb level and CGA indexes whereas patients who did not receive erythropoietin had a lowering of the Hgb levels and worsening of their CGA scores.
Mañas, A., Ciria, J.P., Fernández, M.C., Gonzálvez, M.L., Morillo, V., Pérez, M., . . . López-Gómez, V. (2011). Post hoc analysis of pregabalin vs. non-pregabalin treatment in patients with cancer-related neuropathic pain: Better pain relief, sleep and physical health. Clinical and Translational Oncology, 13, 656–663.
To assess whether the use of pregabalin in combined therapy provides better health outcomes in patients with cancer-related neuropathic pain
This study was a post hoc analysis of data from a previous epidemiologic study of clinical prevalence and analgesic management of neuropathic pain. Patients who received pregabalin versus those who did not were compared. Analgesic management was done at the individual physician’s discretion. Patients had a baseline visit and a final visit at eight weeks. In the initial study, patients were not randomized to different treatment, and numerous other interventions for analgesia were done.
Patients were undergoing active antitumor treatment.
The study was a post hoc analysis of data from a previous epidemiologic study.
The most frequent cause of neuropathic pain was the tumor itself, and cisplatin was the most frequently used chemotherapeutic agent. Fentanyl patches were used more frequently in the pregabalin group. Pain intensity improved in all patients at eight weeks, but improved more with pregabalin (change = 0, 9 points, p = 0.0084). Depression and anxiety decreased significantly in both groups. Physical component and mental component scores on the SF-12 improved in all patients, but improved more in those on pregabalin. When data were adjusted for age and sex, differences from baseline scores were less than 1. There were significant differences in groups in other medications used, numbers of analgesic interventions, and amount of radiation therapy treatment.
It is difficult to draw any firm conclusions regarding efficacy of pregabalin from this study due to the differences in multiple other variables between study groups that could also affect the outcome measures used here. Changes from baseline measures seen at eight weeks were significant, but very small, raising the question of the clinical significance of results.
No firm conclusions can be drawn from these results due to study limitations. Findings aim to show that use of pregabalin for neuropathic pain improves symptoms and health outcomes. Differences from baseline reported here were small, suggesting lack of meaningful differences from a clinical perspective. Results point to the need for nurses to recognize the difference between statistical and clinical significance in evaluating intervention effects.
Maltoni, M., Scarpi, E., Modonesi, C., Passardi, A., Calpona, S., Turriziani, A., . . . Amadori, D. (2005). A validation study of the WHO analgesic ladder: A two-step vs. three-step strategy. Supportive Care in Cancer, 13, 888–894.
To determine if, on the WHO analgesic ladder, passing directly from step 1 to step 3 is more effective than the traditional three-step strategy for treating chronic cancer pain; to evaluate the tolerability and therapeutic index of both strategies
Over 24 months, patients were monitored at home by telephone or a home health nurse. The study design included two arms: in one, patients moved from step 1 to step 3 (with treatment with strong opioids); in the other, patients moved from step 1, to step 2 (with treatment with weak opioids), to step 3.
Italy
Randomized controlled trial
Preliminary data suggest that a direct move to the third step is feasible and could reduce some pain scores. The two-step strategy this study supports requires careful management of side effects.
The study had a small sample size.
Maltoni, M., Nanni, O., Scarpi, E., Rossi, D., Serra, P., & Amadori, D. (2001). High-dose progestins for the treatment of cancer anorexia-cachexia syndrome: A systematic review of randomised clinical trials. Annals of Oncology, 12, 289–300.
To review the prospective randomized clinical trials (RCTs) that evaluate the use of progestins in cancer anorexia-cachexia syndrome compared with placebo in patients with hormone-independent tumors
Databases searched were MEDLINE, CANCERLIT, Embase, and CINAHL, in addition to hand searching of reference lists.
Of the 38 studies identified, 15 RCTs, published between July 1990 and June 1999, met inclusion criteria. The studies selected used various drug dosages, durations of treatment, eligibility criteria, population types, study designs, methods of assessment, methods of reporting results, and outcomes.
The review reported on 2,102 patients, compiled from six studies of 557 patients that received neither chemotherapy nor radiation, and nine studies of 1,545 patients that received some form of concomitant therapy.
Among the several outcomes analyzed, effect on body weight was assessed in all studies, and only two studies did not evaluate the effect on appetite. The most frequent method of assessing appetite was the visual analog scale.
There was a significant advantage for the use of high-dose progestins regarding improved appetite and body weight gain to support the safety and feasibility of treatment with oral progestins.
Most of the studies were short in duration, lasting from 1 to 12 weeks.
Important issues, such as dosage, duration of treatment, best time to start treatment, and eventual impact on overall improved quality of life, have yet to be defined.
Malicka, I., Stefańska, M., Rudziak, M., Jarmoluk, P., Pawłowska, K., Szczepańska-Gieracha, J., & Woźniewski, M. (2011). The influence of Nordic walking exercise on upper extremity strength and the volume of lymphoedema in women following breast cancer treatment. Isokinetics and Exercise Science, 19(4), 295–304.
To examine the effect of Nordic walking on upper-extremity strength and lymphedema
Participants were randomly assigned to the walking group or the control group, who did not participate in any rehabilitation program. The program consisted of two hour-long sessions each week for eight weeks. Sessions involved a 10-minute warm up and 40 minutes of Nordic walking at 85% of maximum heart rate, followed by 10 minutes of stretching and relaxation exercises.
The study took place in an outpatient setting in Poland.
The study used a randomized controlled trial design.
A variety of changes in muscle strength were observed. No differences were found between groups in arm volume results.
The study did not provide any evidence that Nordic walking improved lymphedema.
The study had several methodologic weaknesses and did not provide strong evidence either for or against the effects of Nordic walking on lymphedema after breast cancer treatment.
Maldonado, G.E., Perez, C.A., Covarrubias, E.E., Cabriales, S.A., Leyva, L.A., Perez, J.C., & Almaguer, D.G. (2011). Autologous stem cells for the treatment of post-mastectomy lymphedema: A pilot study. Cytotherapy, 13(10), 1249–1255.
To establish the efficacy of using autologous stem cells (ASC) for the treatment of lymphedema associated with axillary lymph node dissection, define the possible complications, and compare outcomes with compression sleeve therapy
Twenty patients were randomly assigned to the ASC group or the control group. The ASC group received subcutaneously administered granulocyte-colony-stimulating factor (300 mg per day) for three days prior to the procedure. On procedure day, 100 ml bone marrow was harvested from east posterior iliac crest while the patient was under conscious sedation. The product was centrifuged and, under laminar flow hood, plasma was removed and transferred to sterile test tube. Cells were isolated, and CD34 cells were counted using a flow cytometer. A specimen for microbe and 0.5–1 ml of cell suspension containing 20% albumin and normal saline was administered by intramuscular injection at 30–50 sites of the affected limb, depth of 1 cm, with 25 g needle. Injection range included around the axillary and affected chest wall and part of the upper arm during the first four weeks. Use was discontinued for the following four weeks and then used again for another four weeks. Patients were not allowed to use any other modality of treatment for lymphedema, including manual lymph drainage, exercise drug therapy, or skin products. The control group was given a four-hour practice session on correct use of compression sleeve of 15–20 mmHg.
The study took place at the University Hospital of the School of Medicine of the Universidad Autonoma de Nuevo Leon in Mexico.
The study has clinical applicability for late effects and survivorship.
The pilot study randomly assigned 10 women to either the ASC group or control group.
After 12 weeks, the ASC group had decreased pain, improved sensitivity, and improved mobility as compared to the control group. Volume reductions were similar between the two groups, with the control group being more user dependent.
The study does not provide sufficient evidence to determine potential efficacy of stem cell transplant to manage lymphedema.
It is important to be aware of studies being conducted. The study has limited practical value in the United States today, but as ASC becomes a more accepted and standard of care, awareness of the decreases in pain and increased sensitivity and mobility may be of benefit.
Mak, S.S., Zee, C.Y., Molassiotis, A., Chan, S.J., Leung, S.F., Mo, K.F., & Johnson, P.J. (2005). A comparison of wound treatments in nasopharyngeal cancer patients receiving radiation therapy. Cancer Nursing, 28, 436–445.
To compare the effectiveness of gentian violet (GV) and non-adherent absorbent dressing in the healing of moist desquamation
The study group were patients with moist desquamation after irradiation. Wounds were cleansed with 0.9% saline at each visit after completion of the assessment by the nurse. Then a nonadherent dressing was applied and secured with tape. Patients applied the dressing on days they were not seen by the nurse. The control group were patients taught to make homemade salted water, who rinsed the wound and then applied GV. Wound culture was taken at the entry of the study and as needed based on signs of infection.
The study took place at Prince of Wales Hospital at the Chinese University of Hong Kong.
The study used a randomized controlled trial open label design.
No significant differences were found between groups regarding wound healing, healing time, impact of mood changes, social isolation, sleep problems, disturbance in body image, or restriction of neck movement. Initial wound size was greater than 10 cm2. Higher dose of radiation and overall stage were an independent determinant of prolonged time to wound healing. The dressing was not a factor.
The study did not support the use of hydrogel dressings in the care of patients with moist desquamation.