Lowenstein, O., Leyendecker, P., Hopp, M., Schutter, U., Rogers, P.D., Uhl, R., . . . Reimer, K. (2009). Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: A randomised controlled trial. Expert Opinion on Pharmacotherapy, 10, 531-543.
To show the addition of naloxone improves constipation symptoms in patients with non-malignant pain receiving high-dose oxycodone prolonged release (PR).
Patients were randomized to receive either oxycodone PR and naloxone PR or oxycodone PR plus matched oxycodone PR/naloxone placebo. Patients had oxycodone PR titrated to an effective analgesic dose over a 7- to 28-day period and were converted to the study laxative, bisacodyl. Oxycodone immediate release was used as pain rescue medication. Patients were eligible to participate in a 52-week open-label extension. Mean pain over the past 24 hours and bowel function were measured at each study visit and in patient diaries on a daily basis.
This was a double-blind, placebo-controlled, randomized study with an extension phase.
Oxycodone PR/naloxone PR was superior to oxycodone PR at improving bowel function and symptoms of constipation. That improvement was achieved without affecting the analgesic efficacy of the oxycodone component.
The combination of oxycodone PR/naloxone PR in patients with cancer warrants investigation to determine potential benefits in reducing opioid-induced constipation in this population.
Loven, D., Levavi, H., Sabach, G., Zart, R., Andras, M., Fishman, A., . . . Gadoth, N. (2009). Long-term glutamate supplementation failed to protect against peripheral neurotoxicity of paclitaxel. European Journal of Cancer Care, 18, 78–83.
The focus of the study was to evaluate the role of glutamate supplementation in preventing paclitaxel-induced peripheral neuropathy.
Patients were randomized to receive daily placebo or 500 mg glutamate supplementation beginning on the first day of chemotherapy. Treatment was continued throughout six cycles of chemotherapy and for an additional three weeks. Patients were assessed for neuropathy with serial electro-diagnostic measurements at baseline and at the end of the study.
The total sample consisted of 43 women with a median age of 59 years (range of 35–80 years) who were diagnosed with gynecologic cancers and were receiving paclitaxel.
The study was conducted in multiple outpatient sites throughout Israel.
Phase of care
The study had a double-blind, placebo-controlled randomized trial design.
An indication of peripheral neuropathic toxicity was lower in patients receiving glutamate, but the difference was not statistically significant. However, significantly lower pain levels were noted in the glutamate group (p = 0.011). No differences were found between groups regarding electro-diagnostic measurements.
The study does not provide strong support for the benefit of glutamate in the prevention of peripheral neuropathy in patients receiving paclitaxel. No firm conclusions can be drawn due to study limitations.
The findings suggest that glutamate does not prevent peripheral neuropathy during treatment with paclitaxel. Conclusions are limited due to study deficiencies.
Lovell, M.R., Forder, P.M., Stockler, M.R., Butow, P., Briganti, E.M., Chye, R., . . . Boyle, F.M. (2010). A randomized controlled trial of a standardized educational intervention for patients with cancer pain. Journal of Pain and Symptom Management, 40(1), 49–59.
To determine if an educational video and/or booklet for people with advanced cancer and pain can improve pain management and quality of life and decrease anxiety, pain, and pain interference
Patients were recruited from multiple oncology and palliative care clinics and were randomly allocated to one of four treatment groups. Patients in group 1 received standard care only. Those in group 2 received standard care plus a booklet. In group 3, patients received standard care plus a video. Group 4 patients received standard care plus a booklet and video. The video depicted patients, a caregiver, and health professionals talking about cancer pain and management. The booklet, published by the New South Wales Cancer Council, contained text and cartoons about pain and its management. Text was written for a reading age of 12 years. Patient assessment was done at baseline and at weeks 2 and 4 after study entry.
Randomized controlled trial
Barriers were low in all groups at baseline. The barriers scores dropped more in the intervention groups than in the control group, but differences from control or between the other three groups were not significant. There was a significant difference (p < 0.05) in the addiction subscale change in the booklet-only and video-only groups. Authors reported a significantly higher change in average pain (p = 0.0214) between the control and video-and-booklet groups. Authors noted marginal differences in average pain between groups in all other combinations. Reduction in worst pain was significantly greater (p = 0.05) in the video-and-booklet group than in the control group. The size of the differences was small (–1.12). Authors noted no other between-group differences. The presence of a partner increased the effect of any intervention on outcomes (p = 0.004, p < 0.01). According to the pain management index, there was no difference between groups in regard to pain management. Authors observed no difference between groups in regard to anxiety or depression, and they observed no significant change in anxiety or depression. All groups reduced overall consumption of opioids.
In this study a self-administered educational intervention consisting of a booklet and video was associated with a reduction in average pain, worst pain, and fear of addiction.
Findings suggest that standardized education that includes a video and booklet can be helpful in pain management. The effectiveness of the intervention is due, presumably, to greater patient and caregiver involvement in pain management. This study showed that the combination of a booklet and video, along with standard care, was the most effective intervention. The content of each may have reinforced the other. Use of a standardized set of educational materials, such as those used in this study, can be a practical, efficient way to supplement other interventions to manage pain, may be effective in involving patients more directly in pain management, and may help to remove barriers to and misconceptions about pain management.
Loudon, A., Barnett, T., Piller, N., Immink, M.A., & Williams, A.D. (2014). Yoga management of breast cancer-related lymphoedema: A randomised controlled pilot-trial. BMC Complementary and Alternative Medicine, 14, 214.
To determine how women with stage 1 breast cancer-related lymphedema (BCRL) are affected by yoga
Multi-center, randomized, controlled pilot trial using a parallel design with participants allocated to the intervention or control groups on a 1:1 ratio
At week 8, the intervention group had a greater decrease in tissue induration in the affected upper arm compared to the control group (p = 0.050) and a greater reduction in the symptom subscale for quality of life (p = 0.038). There was no difference in arm volume of lymphedema or extracellular fluid between groups at week 8. However, at week 12, arm volume increased more for the intervention group than the control group (p = 0.032).
The outcomes of this small pilot trial provided preliminary evidence that an eight-week Satyananda yoga intervention did not exacerbate lymphedema and improved tissue induration ing the affected upper arm as well as quality of life subscale symptoms. However, the fact that these improvements were not maintained at the one-month follow-up when arm volume was increased suggested that yoga needs to be ongoing. This is one of few studies that addresses tissue induration.
Yoga may reduce tissue induration in the upper arm affected by lymphedema and decrease its associated symptoms. However, additional research trials with longer durations, higher levels of lymphedema, and larger numbers are warranted before definitive conclusions can be made.
Lötzke, D., Wiedemann, F., Rodrigues Recchia, D., Ostermann, T., Sattler, D., Ettl, J., . . . Büssing, A. (2016). Iyengar-yoga compared to exercise as a therapeutic intervention during (neo)adjuvant therapy in women with stage I–III breast cancer: Health-related quality of life, mindfulness, spirituality, life satisfaction, and cancer-related fatigue. Evidence-Based Complementary and Alternative Medicine (eCAM), 2016, 5931816.
To test the effects of yoga on health-related quality of life, life satisfaction, cancer-related fatigue, mindfulness, and spirituality compared to conventional therapeutic exercises during (neo)adjuvant cytotoxic and endocrine therapy in women with stages I–III breast cancer
In a randomized controlled trial (N =119) (with data from 92 used for data analyses), women with breast cancer undergoing oncological treatment were randomly enrolled in a yoga intervention (YI) (n = 45) or a physical exercise intervention (PEI) (n = 47). Measurements were obtained before (t0) and after the intervention (t1), as well as three months after finishing the intervention (t2) using standardized questionnaires.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled trial with active control
Statistically significant results were found on most functional scales of the EORTC, which indicated the spontaneous recovery of patients’ quality of life after chemotherapy and/or radiation. The global health, role, and social functioning of patients in both groups improved significantly, yet neither group significantly differed from the other in these variables. Fatigue, dyspnea, appetite loss, constipation, and diarrhea improved in both groups. For “nausea and vomiting” and “pain,” significant changes were observed over time. No difference existed in life satisfaction, cancer-related fatigue, spirituality, and mindfulness between the groups.
High drop out rate may be related to the number of measurements. One of the concerns was that patients in treatment were having difficulty with the exercise and yoga programs thought to be from the side effects of the treatment. Further study focusing on one or two areas would be beneficial.
The authors felt that this study may have been accepted by patients post-treatment or by using other forms of yoga. Self-care is becoming more common today, and yoga something you can do for yourself. Further investigation should be conducted to see how effective yoga is for patients with cancer.
Lorusso, V., Spedicato, A., Petrucelli, L., Saracino, V., Giampaglia, M., & Perrone, T. (2009). Single dose of palonosetron plus dexamethasone to control nausea, vomiting and to warrant an adequate food intake in patients treated with highly emetogenic chemotherapy (HEC): Preliminary results. Supportive Care in Cancer, 17, 1469–1473.
To evaluate the efficacy of a single-dose palonosetron plus dexamethasone to control emesis in patients receiving highly emetogenic chemotherapy (HEC) and to measure any reduction of calories consumption related to CINV
At baseline, nutritional evaluation subjective global assessment and assessment of appetite were done. Patients received a single bolus of 250 mcg palonosetron plus a single dose of 20 mg dexamethasone 30 minutes prior to chemotherapy. Subjects recorded emesis, nausea, use of rescue medication, and food intake in daily diaries. Amount of food intake was quantified with the aid of pictures of standard portions.
The study was conducted at a single site.
All patients were in active treatment.
This was a prospective trial (noncomparative, single-arm study).
Palonosetron was able to prevent both acute and delayed vomiting and nausea in most patients treated with HEC. A strong, significant relationship was found between the presence of nausea and lower caloric intake.
Lorusso, V., Giampaglia, M., Petrucelli, L., Saracino, V., Perrone, T., & Gnoni, A. (2012). Antiemetic efficacy of single-dose palonosetron and dexamethasone in patients receiving multiple cycles of multiple day-based chemotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20, 3241–3246.
To assess the efficacy of a single dose of palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) and guarantee an adequate food intake in patients receiving several cycles of multiple-day-based chemotherapy
Patients with advanced cancer but without a compromised nutritional status (bone mass > 18.5) receiving multiple cycles of multiple days (MD-CT) were treated with 0.25 mg palonosetron over 30 seconds and 20 mg dexamethasone 30 minutes prior to chemotherapy. Patients recorded the number and intensity of emesis episodes, use of rescue medication, and the time and amount of daily food intake including pictures when available.
This study was conducted at a single site at a hospital in Lecee, Italy.
This was a prospective, uncontrolled trial.
A direct correlation exists between mild nausea and significant decrease in food intake. Patients can easily become malnourished. Nurses need to assess closely for nausea, using a Likert-type scale and weight loss and malnutrition.
Palonosetron and dexamethasone can achieve high control of CINV during multiple days and multiple cycles of HEC. Nurses need to use instruments like the subjective global assessment (SGA) used in this study to better identify patients at risk for malnourishment rather than reyling solely on body mass index (BMI).
Lorusso, D., Ferrandina, G., Greffi, S., Gadducci, A., Pignata, S., Tateo, S. … Scambia, G. (2003). Phase III multicenter randomized trial of amifostine as cytoprotectant in first-line chemotherapy in ovarian cancer patients. Annals of Oncology, 14, 1086–1093.
Patients receiving carboplatin (area under the curve [AUC] 5 mg per minute/ml) and 175 mg/m2 paclitaxel were randomly assigned to receive 910 mg/m2 IV amifostine 30 minutes prior to carboplatin.
The study was conducted between April 1999 and July 2001.
This was a phase III, multicenter, randomized trial.
A significant difference was found in grade 3-4 mucositis (4.7% in the amifostine group versus 15.4% in the control group, p < 0.0001).
Loprinzi, C.L., Qin, R., Dakhil, S.R., Fehrenbacher, L., Flynn, K.A., Atherton, P., . . . Grothey, A. (2014). Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). Journal of Clinical Oncology, 32, 997–1005.
To provide a definitive test of the effectiveness of calcium and magnesium in decreasing oxaliplatin-induced neurotoxicity
Patients randomly were assigned to receive intravenous calcium gluconate and magnesium sulfate at 1 g each in 100 ml of D5W over the course of 30 minutes immediately prior to and after each dose of oxaliplatin. Patients in the control group received a placebo that appeared identical to the study drug with the same administration timing. A third group was administered calcium and magnesium before chemotherapy and a placebo after infusion. Patients with adenocarcinoma of the colon scheduled to receive 12 cycles of FOLFOX chemotherapy including 85 mg/m2 oxaliplatin every two weeks were considered for participation. Oxaliplatin dose modifications were not prescribed by the study, but dosage changes or delays were provided as recommendations. Study measures were obtained at each cycle of chemotherapy.
Three-group, double-blinded, placebo-controlled, randomized trial
There were no significant differences between the three study arms on the EORTC-QLQ CIPN20 sensory or motor neuropathy scales. There were no significant differences in neurotoxicity assessment using the CTCAE to determine time till grade 2 neurotoxicity or incidence of grade 2 symptoms. A subgroup analysis did not show evidence of benefit in groups according to age, sex, disease stage, or specific FOLFOX regimen. There were no differences in acute or chronic symptoms.
The findings of this study do not support the use of intravenous calcium gluconate and magnesium sulfate to prevent oxaliplatin-induced neuropathy.
This large, well designed trial showed no benefit of the use of a calcium gluconate and magnesium sulfate infusions to prevent peripheral neuropathy in patients receiving FOLFOX. The authors of this study state that as many as 50% of practitioners continue to use this intervention, and resources such as UpToDate suggest consideration of this intervention. Nurses can advocate that calcium gluconate and magnesium sulfate not be used for the prevention of peripheral neuropathy given the lack of evidence for its efficacy. This can save time and expense in treatment for patients receiving this type of chemotherapy. Additional similar research may be needed to examine this treatment's effects in patients at risk for peripheral neuropathy related to other chemotherapeutic agents.
Loprinzi, C.L., Kugler, J.W., Sloan, J.A., Mailliard, J.A., LaVasseur, B.I., Barton, D.L., … Christensen, B.J. (2000). Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet, 356, 2059–2063.
Assess more definitively than previous studies the efficacy and toxicity of various doses of venlafaxine for treatment of hot flashes in the breast cancer survivor
Participants were assigned to placebo (n = 56), or venlafaxine 37.5 mg daily (n = 56), 75 mg daily (n = 55), or 150 mg daily (n = 54).
Patients eligible for this trial were 221 women who had a history of breast cancer or who were concerned about taking estrogen therapy for fear of developing breast cancer.
Double-blind, placebo-controlled, randomized trial
It was calculated that a sample size of 50 patients per group would provide 80% power to detect differences in average hot-flash activity of standard deviation (SD) 0–6 (1–2 hot flashes per day, a score of 3 units, or a 21% fall from baseline) with a type 1 error rate of 5%.
Of the 229 patients who joined the study, 191 had data evaluable over the whole study period (50 from the placebo group, 49 from the venlafaxine 37.5 mg group, 43 from the venlafaxine 75 mg group, and 49 from the venlafaxine 150 mg group). After week 4 of treatment, median hot flash scores were reduced from baseline by 27%, 37%, 61%, and 61%, respectively, in the four groups. Frequencies of some side effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group.
The trial suggests that venlafaxine can alleviate hot flashes and that the most appropriate dose for this indication is 75 mg.
Missing data were handled in several ways as a sensitivity analysis of the robustness of the results in relation to the missing data. Less than 10% of possible data were missing, and the results were consistent across a series of analyses by various imputation methods.
The study makes mention that venlafaxine may also be effective against hot flashes in men who have undergone androgen deprivation therapy for prostate cancer.