Lederle, F.A., Busch, D.L., Mattox, K.M., West, M.J., & Aske, D.M. (1990). Cost-effective treatment of constipation in the elderly: A randomized double-blind comparison of sorbitol and lactulose. American Journal of Medicine, 89, 597–601.
To evaluate the use of sorbitol as an inexpensive alternative to lactulose for treating constipation in older adults.
Lactulose and 70% sorbitol (0–60 ml daily) were given for four weeks. During the treatment period, patients were instructed to begin taking 30 ml of the study laxative at bedtime, thereafter adjusting the dose as needed from 0–60 ml. Patients were instructed to maintain high dietary fiber and avoid sources of free fructose such as apples and pears.
The length of the wash-in and washout periods was based on previous studies, which showed up to three to four days are required for lactulose to take effect and the carryover effect after cessation of lactulose is about six to seven days. The study began with a two-week lead-in period, during which patients received lactulose in a single-blind fashion. This was followed sequentially by washout period A (two weeks), treatment period A (four weeks), washout period B (two weeks), and treatment period B (four weeks). The purpose of the lead-in period was to ensure (a) the patient tolerated lactulose, (b) the patient understood how to fill out the diary, and (c) the conditions preceding the two treatment periods were similar. At the end of washout period A, patients were randomly assigned to receive one of the two study laxatives in treatment period A, with the other laxative being used in treatment period B.
The primary endpoints of the study were average number of bowel movements per week and the average number of days per week on which bowel movements occurred.
This was a randomized, double-blind, crossover study.
The results supported the hypothesis that sorbitol and lactulose have no clinically or statistically significant difference in laxative effect. Sorbitol can be recommended as a cost-effective alternative to lactulose for the treatment of constipation in older men.
LeBlanc, J.K., Al-Haddad, M., McHenry, L., Sherman, S., Juan, M., McGreevy, K., . . . DeWitt, J. (2011). A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: One injection or two? Gastrointestinal Endoscopy, 74(6), 1300–1307.
To compare the pain relief achieved by one injection of alcohol versus two injections of alcohol during endoscopic ultrasound–guided (EUS) celiac plexus neurolysis (CPN); to compare the safety associated with the one- and two-injection techniques; to determine the extent to which the number of injections affects the onset and duration of pain associated with pancreatic cancer
Each CPN procedure involved injecting 20 ml 0.75% bupivacaine and 10 ml 98% alcohol into either one or two sites at the celiac trunk. The total sample was composed of 50 patients. Investigators conducted follow-up interviews by telephone to evaluate onset and duration of pain relief and complications. Interviews occurred at 24 hours after the procedure and then weekly.
Prospective single-blinded randomized parallel-group study
Fifty patients were enrolled and randomized. Pain relief was observed in 37 patients (74%): 20 (69%) in the one-injection group and 17 (81%) in the two-injection group. Median onset of pain relief in both groups was one day. Median duration of pain relief in the one-injection and two-injection groups was 11 weeks and 14 weeks, respectively. Complete pain relief was achieved in four patients (8%), two in each group. No long-term complications occurred.
The two techniques were not associated with any significant difference in patients' experience of pain.
Authors observed no difference in the safety associated with the two techniques or the survival rate. Nurses would be justified in advocating for the single-injection technique, to minimize patients' discomfort.
Leal, A.D., Qin, R., Atherton, P.J., Haluska, P., Behrens, R.J., Tiber, C.H., . . . Loprinzi, C.L. (2014). North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: A phase 3 randomized, double-blind, placebo-controlled study. Cancer, 120, 1890–1897.
To determine the effectiveness of glutathione for the prevention of taxol/carboplatin-induced peripheral neuropathy
One hundred eighty-five patients were randomized to receive either placebo or glutathione 1.5 mgm/m2 while receiving paclitaxel and carboplatin therapy over 15 minutes immediately before chemotherapy.
PHASE OF CARE: Active antitumor treatment
Placebo-controlled, randomized, controlled trial
No differences were reported in neurotoxic symptoms between the groups the week following taxol infusion. In addition, no differences were reported between the groups receiving taxol every three to four weeks. Time to development of at least grade 2 neurotoxicity was higher in the placebo group (p = 0.039).
The results indicated that this was a negative trial and do not support the use of glutathione for neurotoxic symptoms from taxol/carboplatin therapy.
The results of this negative trial showed that glutathione was not effective in patients receiving taxol/carboplatin. Very limited evidence supports effective interventions for preventing or minimizing chemotherapy-induced peripheral neuropathy. Ongoing research is needed in this area.
Leach, H.J., Danyluk, J.M., Nishimura, K.C., & Culos-Reed, S.N. (2016). Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. Supportive Care in Cancer, 24, 4597–4606.
Pre-post design
Lazzari, M., Greco, M.T., Marcassa, C., Finocchi, S., Caldarulo, C., & Corli, O. (2015). Efficacy and tolerability of oral oxycodone and oxycodone/naloxone combination in opioid-naive cancer patients: A propensity analysis. Drug Design, Development and Therapy, 9, 5863–5872.
To compare the analgesic efficacy and safety, and quality of life of oxycodone (OXY) compared with oxycodone/naloxone (OXN) combination in treating opioid-naïve patients
Patients were seen at three or four different times when starting long-acting oxycodone products.
PHASE OF CARE: Multiple phases of care
Retrospective, observational, three data collection time periods—T0, T30, and T60. T15 available for patients who needed closer monitoring.
The patients who received OXN had better early improvement in bowel function than the patients who received OXY (p < 0.001).
OXN and OXY have similar analgesic effects, but OXN seems to have better bowel outcomes.
OXN may have better bowel function outcomes compared with OXY in patients starting analgesics.
Lawson, L.M., Williams, P., Glennon, C., Carithers, K., Schnabel, E., Andrejack, A., & Wright, N. (2012). Effect of art making on cancer-related symptoms of blood and marrow transplantation recipients. Oncology Nursing Forum, 39, E353–E360.
To examine the effects of a one-hour art-making session during bone marrow transplantation (BMT) treatment
Interested patients were randomly assigned to the sequence to receive either the art-making session or the control condition first and were then crossed over to the other condition. Art-making sessions were 40–60 minutes. Patients were provided with a ceramic tile, brushes, and paint to create a tile at no cost. Measurements were obtained pre- and postintervention. Patients waited an average of 6.8 days between the treatment and control conditions.
Patients were undergoing active antitumor treatment.
A crossover pre/post-test design was used.
Symptoms declined in post-test measures in both conditions, with significant decline post art making (p = 0.01). There was no significant change in anxiety scores. Salivary cortisol levels declined significantly in both conditions. Time between conditions ranged from 1 to 28 days.
Art making appeared to reduce treatment-related symptoms but had no apparent effect on anxiety.
This pilot study showed that the art-making session appeared to have an effect in reducing treatment-related symptoms; it is not clear if the art making specifically was effective, or if any diversional activity would have the same result. Findings do not support an effect of art making on anxiety.
Lawrence, J.A., Balcueva, E.P., Groteluschen, D.L., Samuel, T.A., Lesser, G.J., Naughton, M.J., . . . Rapp, S.R. (2016). A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy. Journal of Cancer Survivorship, 10, 176–184.
To evaluate the feasibility of taking daily donepezil, an acetylcholinesterase inhibitor, to improve cognitive function in women who report cognitive impairment one to five years after completing adjuvant chemotherapy for breast cancer
This study evaluated the feasibility of a randomized, controlled trial of 24 weeks of donepezil (5 mg/day for 6 weeks, then 10 mg/day for 18 weeks) versus placebo. Potential participants were prescreened for moderate-to-severe self-reported cognitive impairment, and those enrolled were stratified by menopausal status and time since chemotherapy. Self-reported cognitive function, co-occurring symptoms, and quality of life were measured before the trial, halfway through the trial (i.e., 12 weeks), and at the completion of the trial (i.e., 24 weeks). Neuropsychological testing was conducted at baseline and 24 weeks.
Double-blind, randomized, controlled trial of donepezil versus placebo with repeated measures
Donepezil may have some benefit for patients related to changes in cognitive function. Further research is needed to provide strong evidence.
This study primarily showed that future large studies of donepezil in women with breast cancer are feasible. The findings suggest that donepezil may improve memory in breast cancer survivors who report moderate-to-severe cognitive problems. Executive function may improve for some women. Anxiety and insomnia are potential side effects.
Lavu, H., Lengel, H.B., Sell, N.M., Baiocco, J.A., Kennedy, E.P., Yeo, T.P., . . . Yeo, C.J. (2015). A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. Journal of the American College of Surgeons, 220, 497–508.
To examine the efficacy of celiac plexus neurolysis on pain in patients receiving surgical resection for locally advanced disease
Patients who were identified as having unresectable disease underwent open biopsies if indicated and palliative biliary or gastrointestinal bypasses as deemed appropriate. Once it was determined that resection was appropriate, patients were randomly assigned to receive the study intervention or a placebo of normal saline injections. Postoperative pain control consisted of intravenous patient-controlled analgesia. For the analysis, patients were grouped according to resectability and the presence of pain at baseline. Patients were followed for 24 months. Pain was evaluated via patient surveys done every three months. Celiac plexus neurolysis has been shown to reduce pain in patients with advanced pancreatic cancer.
Double-blinded, placebo-controlled, randomized, controlled trial
There were no significant differences in postoperative complications between groups. There were no overall significant differences in pain scores over time between groups. A subgroup analysis showed a reduction in pain at three to nine months among patients with pain at baseline who received surgical resection. There were no differences in pain results from the addition of neurolysis.
This study showed that palliative surgical resection reduced pain as many as nine months after surgery, and that there was no added benefit from celiac neurolysis.
A number of studies have shown that celiac neurolysis is effective in reducing pain among patients with chronic pain associated with unresectable pancreatic cancer. This study suggested that, for those patients where palliative resection is possible, that resection is more effective than neurolysis and that neurolysis in addition to resection did not appear to have additional benefit. There were a number of important limitations in this study. However, it pointed to the value of additional research in this area to determine the most beneficial approaches for long-term pain control in this group of patients.
Lavigne, J.E., Heckler, C., Mathews, J.L., Palesh, O., Kirshner, J.J., Lord, R., . . . Mustian, K. (2012). A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors. Breast Cancer Research and Treatment, 136, 479–486.
To compare the efficacy of gabapentin 300 mg and 900 mg for controlling anxiety symptoms among breast cancer survivors
Patients were randomly assigned to receive 300 mg or 900 mg of gabapentin or placebo daily. Outcomes were assessed at baseline, four weeks, and eight weeks.
Patients were undergoing the transition phase of care after initial treatment.
A double-blind, placebo-controlled, randomized controlled trial design was used.
At four weeks, patients on gabapentin showed significant reduction in anxiety scores (p = 0.005). Patients with the highest baseline anxiety scores had the greatest improvement, and those with low anxiety levels had little change. These patterns were maintained at the eight-week follow-up. The greatest improvement in anxiety was seen in those getting 300 mg of gabapentin. Anxiety scores of those on placebo also declined, but changes were not significant.
Gabapentin 300 mg daily was effective in reducing symptoms of anxiety in these breast cancer survivors.
This study demonstrated that 300 mg of gabapentin daily was effective in controlling anxiety symptoms among breast cancer survivors who had been experiencing hot flashes and had relatively high baseline anxiety. Gabapentin is currently off label in psychiatry to treat anxiety symptoms and commonly used to treat hot flashes and neuropathic pain in breast cancer survivors. As shown in other research, improvement in anxiety symptoms tends to be found in patients who have clinically relevant levels of anxiety to begin with. Nurses can consider and advocate for use of gabapentin to manage anxiety in these patients.
Lauritano, D., Petruzzi, M., Di Stasio, D., & Lucchese, A. (2014). Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: A case-control study. International Journal of Oral Science, 6, 27–30.
To evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy for pediatric patients with acute lymphoblastic leukemia
Twenty patients received palifermin and other 20 patients didn’t. The palifermin group received a 60 mg/kg IV bolus per day for three consecutive days before and three consecutive days after transplant (a total of six doses). All patients were evaluated for 30 days.
Case-controlled study
This study demonstrated a statistically significant reduction in the duration of parenteral nutrition (p = .002), duration of mucositis (p = .003), and the average grade of mucositis (p = .03). Other measures were not significant. The statistical analysis showed that the drug decreased the severity of mucositis.
These data suggest that palifermin could be a valid therapeutic adjuvant to improve quality of life for pediatric patients with leukemia.
Palifermin decreased the duration of oral mucositis in pediatric patients being treated for leukemia. Nurses should be aware that this intervention may compliment other interventions to reduce oral mucositis in this population.