Gerber, G.S., Zagaja, G.P., Ray, P.S., & Rukstalis, D.B. (2000). Transdermal estrogen in the treatment of hot flushes in men with prostate cancer. Urology, 55, 97–101.
The study evaluated the efficacy of transdermal estrogen in men in moderating hot flashes after hormonal therapy for prostate cancer.
The study enrolled 12 men with advanced prostate cancer who were receiving leuprolide injections every one or three months. They were experiencing at least three hot flush episodes daily for at least three months.
This was a randomized, multi-dose, crossover trial.
Treatment response was assessed indaily logs. Questionnaires were completed every four weeks, including visual analog assessment. Serum luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, and estradiol levels were taken every four weeks.
Key outcomes of the study included:
Study limitations included small sample size, absence of placebo arm, short duration.
Gentili, M., Clerico, M., Spizzichino, M., & Fanelli, G. (2016). Use of a checklist to improve pain control in hospitalized cancer patients: The 38Checkpain project. Future Oncology, 12, 199–205.
To evaluate whether use of a checklist dedicated to pain management-related practices would improve pain control in inpatient settings
A checklist (38Checkpain) was developed by a group of patient management experts identifying practices related to pain management outlined in Italian law. The checklist consisted of seven items to remind practitioners of correct steps for assessment, monitoring, management, and treatment of pain. Healthcare centers participating in the program collected information on these aspects of pain management, adverse of effects, and episodes of breakthrough pain for all patients hospitalized that day on the unit for seven days. After, healthcare centers were randomized to use the checklist or to continue current practice without use of the checklist. Checklist items were measuring intensity of pain, checking if pain was 3 or less, modifying therapy if pain intensity was greater than 3, assessing the presence of adverse events with pain treatment, setting a specific therapy of adverse event management, checking for presence of factors that increase acute pain, and setting a specific therapy for treatment of factors that cause acute pain. The checklist was applied in patients with pain twice daily by providers. Data were collected for 21 days.
Mean pain intensity declined in the checklist group over the study period from 3.8–2.7. Mean pain intensity did not decline steadily in the no checklist group and overall was consistently higher. The proportion of patients with effective control of pain increased from 20.1% to 67.6% in the checklist group. In the no checklist group, control of pain increased by 13.8%. The incidence of breakthrough pain episodes decreased by 21.4% in the checklist group but increased by 6.6% in the other group. Compliance with checklist use was reported as at least once daily.
The use of a checklist to remind healthcare providers to make specific assessments and intervention plans for patients with pain appeared helpful in improving overall pain-related patient outcomes.
This study has multiple limitations; however, it does suggest that at least daily use of a checklist reminder for assessment and intervention practices for patients with pain may improve overall pain management and related patient outcomes. Checklists have been used in multiple ways in health care and may be an effective tool in reminding practices to improve various types of patient outcomes.
Genot-Klastersky, M.T., Klastersky, J., Awada, F., Awada, A., Crombez, P., Martinez, M.D., et al. (2008). The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: Results from two prospective studies. Supportive Care and Cancer, 16(12), 1381–1387.
100 mW laser was delivered to tissues with a 1.2 mm spot size. Treatment areas included inferior and superior lips, right and left cheeks, right and left tongue, palate and velum palate, right and left gums, and tongue frenulum.
Average energy was 2 J/cm2 on all sites, with a calculated mean duration of 33 seconds per site; each treatment lasted six minutes.
(1) Patients with various solid tumors treated with chemotherapy; previous oral mucositis of 2 or higher
26 patients for 90% power
Patients with concomitant RT and those \"expected to be poor compliers to the treatment schedule\" were excluded.
Mean age 51 was years (range = 32–73 years).
20 women; 6 men
(2) Randomized trial for patients with hematologic malignancies who developed mucositis receiving radiochemotherapy prior to HSCT. Therapy started 24 hours after diagnosis of mucositis. Sham laser control was used.
20 patients were needed in each arm for 90% power.
n = 36 (18 patients in each arm)
Grade of mucositis using EORTC scale
Grading was performed by a nurse prior to each treatment session and afterward once a week by an independent blinded professional observer.
All treated areas were examined.
1. 21 of 26 patients were considered to have prevented mucositis (81%, 95% CI = 61%–93%); 4 with no mucositis, and 17 with grade I. Five patients had grade 2 or higher; median duration was 10 days (range = 8–14 days).
2. Grade 3 mucositis was observed in 16 patients in the sham group and in 3 LEL treated patients (p = 0.001). Overall success rate was 15 of 18 (83%, 95% CI = 59%–96%) and 2 of 18 in the control group (11%, 95% CI = 1–35).Time to grade 3 mucositis was calculated (p < 0.0001).
Of 16 patients in the control arm who developed grade 3–4, eight later received laser treatment; regression to grade 1 mucositis was three days in this group and four days in those who did not receive LEL.
Limited sample size, although the prevention trial (1) achieved 90% power.
The heterogeneous population in the prevention trial makes the results difficult to generalize. Oral care and other factors were not reported.
Gennaro, P., Gabriele, G., Mihara, M., Kikuchi, K., Salini, C., Aboh, I., . . . Ungari, C. (2016). Supramicrosurgical lymphatico-venular anastomosis (LVA) in treating lymphoedema: 36-months preliminary report. European Review for Medical and Pharmacological Sciences, 20, 4642–4653.
To evaluate the effects of lymphaticovenular anastomosis (LVA) on patients with lymphedema
APPLICATIONS: Pediatrics, elder care
Retrospective
Measuring tape
The LVA appears to successfully establish alternate lymphatic drainage pathways in the lymph damaged limb. It is minimally invasive requiring considerably less surgery than the lymph node transplantation procedures and potentially better outcomes. The patients tolerate it well and recovery quickly. It is unclear whether patients no longer needed to use compression garments, but the study reported that all had a reduction in compression class. The researchers reported outcomes that did reflect disease progression: Stage IV limbs did not improve, as well as stage II.
The findings suggest that LVA may be helpful for patients to reduce lymphedema. Nurses need to be aware of patient education needs if this procedure is used.
Gennaro, M., Maccauro, M., Sigari, C., Casalini, P., Bedodi, L., Conti, A. R., . . . Bombardieri, E. (2013). Selective axillary dissection after axillary reverse mapping to prevent breast cancer–related lymphoedema. European Journal of Surgical Oncology, 39, 1341–1345.
To assess the occurrence of breast cancer–related lymphedema (BCRL) and the feasibility of selective axillary dissection (SAD) after axillary reverse mapping (ARM)
ARM was performed on 60 patients undergoing SAD. Patients received follow-up after 6–36 months and were assessed for BCRL.
The intervention group participated in the SAD intervention, and the control group usually had axillary lymph node dissection.
SAD was successful in 45 of 60 patients. Four of 45 patients in the intervention group and five of 15 patients in the control group developed lymphedema (p = .072).
BCRL with SAD technique after median follow-up of 16 months had 33% the rate of lymphedema occurence than conventional ALND. SAD technique requires a separate surgery from sentinel lymph node biopsy. Authors concede there may be a learning curve to this technique, and further research is needed to determine appropriate patient selection.
New surgical techniques may result in lowering patient morbidity but does not eliminate the possibility of patients developing BCRL. Education should continue to be provided to all patients regarding early identification of signs and symptoms of BCRL.
Geng, C.J., Liang, Q., Zhong, J.H., Zhu, M., Meng, F.Y., Wu, N., . . . Yuan, B.Y. (2015). Ibandronate to treat skeletal-related events and bone pain in metastatic bone disease or multiple myeloma: A meta-analysis of randomised clinical trials. BMJ Open, 5(6), e007258-2014-007258.
STUDY PURPOSE: To evaluate the effects of ibandronate relative to placebo or zolendronate for treatment of skeletal-related events and bone pain in patients with cancer
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Late effects and survivorship
APPLICATIONS: Palliative care
IV or oral ibandronate was significantly better than placebo for pain reduction (WMD = -0.41, p < 0.00001). No significant differences in pain outcomes were seen between ibandronate and zoledronate. Incidence of renal toxicity was lower with ibandronate compared to zoledronate (RR = 0.71, p = 0.006). Incidence of skeletal-related events was lower with ibandronate compared to placebo (p = 0.002). There was no significant difference in skeletal-related events between ibandronate and zolendronate and no difference in other adverse events.
IV ibandronate every three to four weeks or daily oral medication was effective in reducing skeletal events and pain in patients with bone metastases, and was associated with lower incidence of renal toxicity than zoledronate.
Ibandronate is effective in reducing pain from bone metastases and multiple myeloma, and in preventing skeletal events in these patients, with efficacy similar to that of zoledronate. This analysis also showed that ibandronate was associated with lower prevalence of renal toxicity compared to zoledronate, so it may be a preferred choice for some patients with relevant comorbid conditions. Further research is needed to fully compare efficacy of oral versus IV administration.
Ekti Genc, R., & Conk, Z. (2008). Impact of effective nursing interventions to the fatigue syndrome in children who receive chemotherapy. Cancer Nursing, 31, 312–317.
The primary aim was to examine the effects of a nursing intervention for fatigue on children aged seven to 12 years who received chemotherapy. The secondary aim was to examine the relationship between fatigue and demographic variables, diagnoses, and therapy-related variables.
The experimental group received education about fatigue with chemotherapy and a fatigue handbook. Education provided included specific activities that decreased fatigue. Children were also walked in the hallway for physical activity. The control group was given routine nursing care. These activities were performed for one week. Participants were randomly assigned.
This was a randomized, controlled trial.
The difference between the two mean values on the FS-C between the experimental and control groups was statistically significant (p < 0.00). The difference between the two mean values of the FS-P between the experimental and control groups was statistically significant (p < 0.00).
The study showed some promise for an intervention to reduce fatigue. However, fatigue was not eliminated in the experimental group, and baseline fatigue scores were not collected from either group.
It would be feasible to perform the study procedure for the experimental group in practice if the education continued to prove effective on fatigue.
Genc, F., & Tan, M. (2014). The effect of acupressure application on chemotherapy-induced nausea, vomiting, and anxiety in patients with breast cancer. Palliative & Supportive Care. Advance online publication.
To determine the effects of acupressure applied to the pericardium 6 (P 6) acupuncture point on chemotherapy-induced nausea and vomiting (CINV) and anxiety in patients with breast cancer undergoing chemotherapy
Stage 1–3 patients with breast cancer who were receiving cycle two and more advance-cycle chemotherapy in an ambulatory setting were trained to apply P 6 acupressure. Patients were randomly selected from a sample that met the study inclusion criteria. An acupressure wrist band was utilized with the research group. Patients were taught how to use the band with repeat demonstration. Patients continuously wore the acupressure band on both wrists for five days. Antiemetic medications used for the experimental and control group were not described.
The authors concluded that acupressure wristbands applied at the P 6 point decreased patients' nausea occurrence and experience and the overall experience and occurrence of nausea, vomiting, and retching combined. There was no effect on the occurrence or experience of vomiting or retching. Acupressure is an inexpensive intervention that may be able to provide additional relief to patients above and beyond recommended antiemetic therapy. Effects on anxiety are unclear.
Acupressure is inexpensive, is easy to use, and can be considered in conjugation with medication or CINV prophylaxis. Acupressure can be considered in addition to recommended antiemetic therapy for additional support of patients experiencing CINV.
Genç, A., Can, G., & Aydiner, A. (2012). The efficiency of the acupressure in prevention of the chemotherapy-induced nausea and vomiting. Supportive Care in Cancer, 21, 253–261.
To examine the efficiency of acupressure in controlling chemotherapy-induced nausea and vomiting (CINV) and to determine the factors that affect this efficiency
Turkish researchers recruited patients with lung, breast, and gynecological cancer who were undergoing active treatment with medicines such as doxorubicin- or cisplatin-based drugs. The researchers randomized and assigned 67 patients in the experimental group and 53 patients in the control group. The experimental group was given a real nausea wristband (Sea-Band), and the control group was given a placebo nausea band. All patients in both groups also were given standard antiemetic treatment. They were instructed to use the wristband on both of their wrists for five days, except when sleeping at night, washing their hands, and taking a shower.
The study was conducted at a single site in Turkey. The setting type was not specified.
Patients were undergoing the active treatment phase of care.
The study was a cross-sectional, single blinded study.
The researchers stated that they created a patient description form to collect the demographic information, chemotherapy medications, and characteristics of the condition of the patients. They also used two measurements.
The researchers investigated whether acupressure affected the patients’ quality of life, as well as their experiences and development of nausea, vomiting, and retching. After five days of treatment, the results indicated that no statistically meaningful difference was observed between the control and experimental groups. Therefore, real acupressure application was not an effective strategy to increase the quality of life or to decrease the experience of CINV.
The statistical results show that after five days, both experimental and control groups had almost identical scores. Therefore, the real nausea wristband does not affect CINV or the quality of life.
The study shows that wristband acupressure is not effective in controlling CINV in patients with cancer. Additional studies are needed to confirm or refute this conclusion. Acupressure may need to be organ-site specific to control CINV.
Gehring, K., Patwardhan, S.Y., Collins, R., Groves, M.D., Etzel, C.J., Meyers, C.A., & Wefel, J.S. (2012). A randomized trial on the efficacy of methylphenidate and modafinil for improving cognitive functioning and symptoms in patients with a primary brain tumor. Journal of Neuro-Oncology, 107, 165–174.
To compare the effectiveness of immediate-release or sustained-release methylphenidate versus modafinil in improving cognitive function in patients with primary brain tumors.
Patients were randomized to receive one of the following three interventions for a total of four weeks.
Neurocognitive tests were done prior to the initiation of the intervention and repeated approximately 30 days later after completion of the intervention.
Patients were in mutliple phases of care.
The study was conducted as a randomized clinical trial.
Objective Cognitive Function Instruments
Subjective Anxiety Instruments
Subjective Depression Instruments
Subjective Fatigue Instruments
Subjective Sleep-Wake Disturbance Instrument
In regards to cognitive function, no differences were found over time with either stimulant in attention or motor function. Mixed results were found over time with stimulant use in speed of processing: significant improvement was found with the WAISIII digit symbol test (p = 0.02), but not with TMT-A. Similarly, a significant decline was found in memory as measured by the delayed recognition subtest of the HVLT (p = 0.03), but not with other subtests of that measure. When evaluating any stimulant use over time in regard to executive function, a significant improvement was found as measured by the TMT-B (p = 0.02) but a significant decline was found as measured by the COWA (p = 0.02). When evaluating differences between the methylphenidate and modafinil treatment groups over time, a significant difference was found in attention (p = 0.05): patients on methylphenidate had stable scores as measured by the digit span test and those on modafinil had worse scores over time. Likewise, a difference was seen in speed of processing (only as measured by the TMT-A) that found patients on modafinil improved in comparison to patients on methylphenidate, who either remained stable or had slight declines (p = 0.05)
In subjective measures of other symptoms, significant improvement was found over time with any stimulant use in depression as measured by the BDI (p < 0.01) and the POMS-Depr (p < 0.01), fatigue as measured by the BFI (p = 0.04) and POMS-fatigue (p < 0.01), and anxiety as measured by the STAI-state (p = 0.03). In contrast, no differences were seen over time for sleep-wake disturbances. No differences were found between treatment groups in subjective symptom measures over time.
Although the study found some improvements in specific cognitive domains over time (e.g., executive function, speed of processing), it is unclear whether these improvements were because of the use of a stimulant, a specific medication (modafinil versus methylphenidate), or other variables such as practice effects (related to the absence of alternative forms for neuropsychological tests). It is difficult to make any definitive interpretations based on this small study, because findings are confounded by the use of two different stimulants (one with two different dosing schedules) and the lack of a control group (patients who were not receiving stimulants).
The study does not provide any support at this time to recommend the use of stimulants to improve cognitive function. Future research studies with larger sample sizes and randomized clinical trials with a nonintervention arm are warranted.