Lesniak, W., Bala, M., Jaeschke, R., & Krzakowski, M. (2008). Effects of megestrol acetate in patients with cancer anorexia-cachexia syndrome—A systematic review and meta-analysis. Polskie Archiwum Medycyny Wewnetrznej, 118, 636–644.
To assess the clinical effects of megestrol acetate (MA) on anorexia-cachexia syndrome (ACS) via systematic review and meta-analysis
The MEDLINE, Embase, and Central databases were used to find research from 2002–2007. The previous systematic review by Lopez et al. (2004) was used to identify additional references. Reference lists of the studies included were also reviewed.
The search keywords used were neoplasm, cancer, cachexia, anorexia, and megestrol acetate.
Inclusion criteria were:
There were no language restrictions for the studies included. The review also included conference abstracts. No flowchart or additional description of initial study volume or eliminations was provided. The validity of eligible studies was assessed to ensure intent-to-treat analysis and completeness of follow-up.
Findings were presented for studies in 21 different categories. These categories were defined according to MA dose; outcomes evaluated; and whether MA was dispensed in varying doses, compared to a placebo, or compared to other drugs, with relative risk findings for effect size.
Pooled analysis was completed and statistical significance of overall effects was calculated via the Z-test. Homogeneity of results between studies was analyzed with the chi-square test. Results were summarized by GRADE group categorization.
MA administration is associated with appetite improvement, increased probability of weight gain, and a higher probability of delay in deterioration of performance status. The conclusions regarding MA's influence on other symptoms, quality-of-life indices, and performance status were not clear.
There appears to be a dose-response relationship for achievement of weight gain. To obtain improved appetite, it appears that a low dose of MA (160 mg) is as effective as higher doses. At this low dose, there was a beneficial trend compared to the placebo, and a significant effect of a dose increase has not been demonstrated.
The effects of MA are not significantly different than those of glucocorticosteroids. In a previous review, lower-extremity edema in short-term follow-up and potential increased risk of embolic complications in long-term follow-up were identified as adverse effects of MA
Results suggest that MA has a beneficial effect on appetite.
Lesi, G., Razzini, G., Musti, M.A., Stivanello, E., Petrucci, C., Benedetti, B., . . . Artioli, F. (2016). Acupuncture as an integrative approach for the treatment of hot flashes in women with breast cancer: A prospective multicenter randomized controlled trial (AcCliMaT). Journal of Clinical Oncology, 34, 1795–1802.
To evaluate the effectiveness of acupuncture plus self-care versus self-care alone on hot-flashes control in patients with breast cancer
Assignment to either the acupuncture or control group was 1:1. Both groups received an informational booklet about climacteric syndrome and its management and was followed for at least 12 weeks. The acupuncture group also received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints. Quality of life and climatic symptoms were measured at week 12, 3 months, and 6 months.
PHASE OF CARE: Transition phase after active treatment
A phase III, multicenter, randomized, controlled trial with acupuncture and self-care versus self-care alone
Mean HFS at week 12, finalizing the treatment, was 22.7 for the control group and 11.3 in the acupuncture group. Differences in mean HFS were 9.3 (95% confidence interval [214.2, 24.4], p < 0.001). A greater reduction in HFSs were observed in the acupuncture group during the basal, third, and sixth month controls for hot flashes, and a similar reduction was found on the GCS-Greene Climacteric Scale. Twelve patients in the acupuncture arm reported mild adverse events (i.e., muscle pain, headache, and one menstrual bleed). No serious adverse events were reported in either group.
The authors demonstrated that acupuncture plus the self-care intervention during 12 weeks was more effective to decrease the hot flashes than self-care alone. All health-related quality of life dimensions were ameliorated except for sexual dimension. The positive affect persisted for six months after intervention.
Because many women with breast cancer are reluctant to take drugs for hot flashes, nurses can give educational and advice about the effectiveness of acupuncture. The self-care booklet may be a useful tool, but additional investigation of its validity in use with women taking medication for hot flash management is needed.
Leppert, W., & Majkowicz, M. (2010). The impact of tramadol and dihydrocodeine treatment on quality of life of patients with cancer pain. International Journal of Clinical Practice, 64(12), 1681–1687.
To compare the impact of tramadol to that of dihydrocodone (DHC) treatment on the quality of life (QoL) and performance status (PS) of patients with cancer pain
Patients received treatment with either tramadol or DHC controlled-release tablets for seven days. Then drugs were switched and administered for another seven days. QoL and PS were measured at baseline, at the 7th day, and on the 14th day of therapy.
Randomized crossover trial
DHC treatment was associated with better global QoL, cognitive functioning, analgesia, and appetite and with less fatigue, sleep disturbances, nausea, and vomiting. Tramadol therapy was associated with better emotional functioning, less constipation, and fewer financial problems. Performance status deteriorated in both groups.
Findings suggest that the decision between tramadol and DHC should be based on each patient's status and symptoms of concern. To date, no other studies have compared tramadol to DHC in patients with cancer-elated pain. Further research would be beneficial.
Leppert, W. (2014). Oxycodone/naloxone in the management of patients with pain and opioid-induced bowel dysfunction. Current Drug Targets, 15, 124-135.
PHASE OF CARE: Multiple phases of care
APPLICATIONS: Palliative care
Oxycodone plus naloxone (OXN) appeared to provide similar analgesic effects as oxycodone, but it also improved bowel function, defined as more frequent and complete spontaneous bowel movements and less consumption of laxatives. In addition, OXN improved the passing of urine in patients with postoperative pain while reducing OIBD, improving compliance, and enhancing quality of life. OXN may be administered to opioid-naïve patients with moderate to severe pain and to patients not responding to weak opioids. The evidence from studies of chronic nonmalignant and cancer-related pain demonstrated the role of OXN in the prevention and treatment of OIBD in patients who required opioid therapy for moderate to severe pain. An evaluation of the value of the literature and studies was not evident in this article.
OIBD is a common complication in patients receiving long-term opioid treatment. The use of OXN was demonstrated by a number of studies to be effective for the management of pain and to have a role in the prevention of OIBD in patients with moderate to severe chronic nonmalignant and cancer-related pain.
Demographic characteristics were generally well-balanced between OXN groups and placebo or oxycodone groups. However, there was a larger sample size of patients with cancer-related pain in one specific study that could have altered the results. There was a high rate of variability in the type of studies that were included, and there was no critical analysis of the literature.
OXN appears to provide similar analgesic effects as oxycodone, but it improves bowel function, defined as more frequent and complete spontaneous bowel movements and a less frequent consumption of laxatives. In addition, patients receiving OXN had improved quality of life scores with decreased OIBD complications.
Leow, M., Chan, S., & Chan, M. (2015). A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer. Oncology Nursing Forum, 42, E63–E72.
To evaluate the efficacy of the Caring for the Caregiver Program (CCP) to enhance the quality of life of the caregivers of patients diagnosed with advanced cancer compared to caregivers who receive standard care
Participants were randomized to receive the intervention using CCP plus standard care or standard care from home Hospice providers. Two post-test measures were used at four and eight weeks postintervention. The CCP intervention was comprised of a one-hour, face-to-face session to develop a plan of care, a video clip, two follow-up phone calls, and an invitation to join an online social support group.
Pilot-randomized, controlled trial with a two-group pretest and repeated post-test
The CCP had a positive effect on family caregivers providing care to patients with advanced cancer.
Identifying at-risk caregivers and implementing a CCP intervention can improve the experience of patients with an advanced diagnosis of cancer and their caregivers. These types of interventions have the potential to decrease caregiver strain and burden by improving access to social supports and improving knowledge and self-efficacy.
Leonardi, M.C., Gariboldi, S., Ivaldi, G.B., Ferrari, A., Serafini, F., Didier, F., . . . Orecchia, R. (2008). A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: Interim analysis. European Journal of Dermatology, 18, 317–321.
To assess the efficacy of MASO65D (Xclair™) in managing radiation dermatitis (RD) during radiation therapy and the follow-up period
Patients were randomized to use of MASO65D or the control cream. The control vehicle was an emollient-based cream that was similar in color and consistency but did not contain key ingredients. Patients had to observe a washout period of seven days. Patients were also instructed to apply study cream on the irradiated area three times daily, starting on first day of irradiation and continuing until three weeks after completion of radiation therapy. Patients were examined at weekly intervals during radiation therapy and three weeks after its completion.
The study took place at the European Institute of Oncology in Milan, Italy.
The study used a randomized double-blind vehicle-controlled design.
The study demonstrated a statistically significant difference between vehicle and MAS065D groups regarding the maximum severity of skin toxicity (p < 0.0001), symptoms of burning within the radiation field (p = 0.039), and desquamation (p = 0.02). In the MAS065D group, 13.5% reported mild-to-moderate desquamation, compared with 50% in the vehicle group. A higher proportion of the experimental group had no desquamation. The most significant differences between the two groups were recorded after three weeks of treatment. Both study creams were well tolerated for their cosmetic acceptability. No adverse events were observed or reported in either group of patients who completed the study.
MAS065D had a significantly better outcome with prevention and treatment of skin reactions.
León-Pizarro, C., Gich, I., Barther, E., Rovirosa, A., Farrús, B., Casas, F., . . . Arcusa, A. (2007). A randomized trial of the effect of training in relaxation and guided imagery techniques in improving psychological and quality-of-life indices for gynecologic and breast brachytherapy patients. Psycho-Oncology, 16, 971–979.
The intervention consisted of relaxation and guided imagery provided to patients during hospitalization. The intervention group received training in relaxation and guided imagery for 10 minutes and was given an individualized cassette for use at home and at the hospital. The recording on the cassette consisted of instructions on head-to-toe relaxation and breathing techniques. Patients were then given descriptions of pleasing images (mountains, beach, etc.) based on information gathered from the patients prior to recording of the cassette. Patients in both groups received training regarding brachytherapy, but only study group patients received training in relaxation and guided imagery.
Two hospitals in Spain
A randomized controlled trial design was used.
The intervention group demonstrated a statistically significant reduction in anxiety (p = 0.008) compared with the control group.
Lennernas, B., Frank-Lissbrant, I., Lennernas, H., Kalkner, K.M., Derrick, R., & Howell, J. (2010). Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain: Results from a randomized phase II study. Palliative Medicine, 24(3), 286–293.
To evaluate the efficacy and tolerability of sublingual fentanyl for the treatment of breakthrough pain in opioid-tolerant cancer patients
This study was conducted from July 2002 to January 2004 at five university clinics in Sweden. Patients had locally advanced or metastatic cancer and were currently
Each patient received, at four pain episodes occurring between 0700 and 1600 (defined as the treatment period), a placebo dose and 100, 200, and 400 mcg doses of sublingual fentanyl. The doses were provided in a random order, according to a computer-generated randomization list. At least one day fell between each treatment period, to avoid carry-over effects. Patients were asked to rate their pain at the onset of an episode of breakthrough pain and then at 5, 10, 15, 20, and 30 minutes postingestion of the study drug. At 60 minutes, the patients were asked to make a global assessment of the treatment by using a four-point scale.
Randomized, multicenter double-blind, four-period crossover study
Twenty-three patients completed all four treatment doses. Twenty-two of the 23 patients (95%) reported that at least one dose of the sublingual fentanyl produced a clinically important decrease in pain intensity, as measured by a decrease in pain intensity of more than 20 mm on the VAS. In regard to adverse events, 13 patients reported 15 adverse events considered to be related to the study drug. The most common treatment-related adverse effects were nausea and dizziness. Increasing the doses of sublingual fenanyl did not appear to increase the number or severity of adverse events, when evaluated related to increasing doses of sublingual fentanyl.
Within 15 minutes of administration, 400 micrograms of sublingual fentanyl proved more effective than placebo at significantly improving overall pain intensity difference. This was true over the entire treatment period. In regard to reducing pain intensity, results showed that the 100 and 200 mcg doses of sublingual fentanyl were more effective than placebo.
Further study is needed to determine, in regard to decreasing breakthrough pain, the efficacy of each of the doses of sublingual fentanyl.
Lengacher, C.A., Reich, R.R., Paterson, C.L., Jim, H.S., Ramesar, S., Alinat, C.B., . . . Kip, K.E. (2015). The effects of mindfulness‐based stress reduction on objective and subjective sleep parameters in women with breast cancer: A randomized controlled trial. Psycho‐Oncology, 24, 424–432.
To investigate the effects of mindfulness-based stress reduction (MBSR) on sleep parameters in women with breast cancer
Patients were randomized to the MBSR group or a usual care wait-list control group. MBSR was delivered in two-hour weekly sessions six times, including educational materials related to relaxation, meditation, healthy lifestyle, practice of meditation, yoga, body scan and walking meditation, and supportive group interaction and discussion. Patients were asked to practice meditative techniques 15–45 minutes daily. Study measures were obtained at baseline, six weeks, and 12 weeks.
Randomized, controlled trial
From baseline to six weeks, there were no differences between the groups. From 6–12 weeks, there were improvements in the MBSR group in sleep efficiency and the number of times patients awoke as measured by actigraphy (between groups Cohen’s d = 0.33 – 0.38; p = 0.04; p < 0.01). There were no differences between groups in PSQI or sleep diary findings. Sleep efficiency, the percent of time per night in sleep, was 78.2% in the MBSR group compared to 74.6% in the control group. All sleep parameters improved in both groups. There was no correlation between how much individuals practiced and sleep outcomes.
The use of MBSR resulted in improvements in some sleep parameters.
The findings of this study suggest that MBSR as provided in this intervention might improve some sleep parameters compared to usual care control patients; however, sleep parameters did improve over time in all participants. This is a low-risk type of intervention, but it involves multiple sessions delivered in person. It is not known whether different delivery methods can be successful, what the appropriate and necessary timing should be, or what the frequency and duration of the delivered interventions should be.
Lengacher, C. A., Reich, R. R., Post-White, J., Moscoso, M., Shelton, M. M., Barta, M., . . . Budhrani, P. (2012). Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. Journal of Behavioral Medicine, 35, 86–94.
To compare the prevalence and severity of symptoms and symptom clusters in patients with breast cancer who participated in a mindfulness-based stress reduction (MBSR) program to the symptoms and symptom clusters in patients who received usual care.
Women who expressed interest in participating in the study were randomly assigned to MBSR or usual care. The MBSR program lasted six weeks and included educational material, meditation practice in weekly group settings and homework, group discussion on barriers to meditation, application of mindfulness in daily life, and group support interactions. Meditation training consisted of sitting and walking meditation, body scan, and gentle Hatha yoga. Researchers obtained study measures at baseline and within two weeks of program conclusion. Hierarchical-cluster analysis was used to identify symptom clusters. Researchers compared each group's symptom clusters and individual symptoms to those of the other group.
This was a randomized, controlled trial.
MD Anderson Symptom Inventory
Severity of symptoms declined in both groups from baseline to the end of the study. Fatigue and drowsiness declined more in the MBSR group (p = 0.05). Interference scores for mood and relationships also declined more in the MBSR group (p ≤ 0.05). Analysis of changes in symptom clusters showed no differences between groups. Clusters identified were gastrointestinal (nausea, vomiting, anorexia, shortness of breath, dry mouth, numbness), cognitive or psychological (distress, sadness, pain, remembering), and fatigue (fatigue, disturbed sleep, drowsiness). Cluster scores declined in both groups.
Findings suggested that MBSR interventions may benefit women with breast cancer who are managing fatigue or mood.
Findings suggested that MBSR may be helpful, to some patients with breast cancer, as a means of combating fatigue and mood changes. Study limitations limited the strength of these findings.