Weller, M., Cosmos, E., DeBruyn, J., & Brader, K. (2008). The use of energy healing for ovarian cancer patients. Society of Gynecologic Nurse Oncologists, 18(4), 29–33.
To examine the effects of Ama Deus healing energy in reducing anxiety and depression in patients with a diagnosis of stage III ovarian cancer
The study involved three weeks of intervention or control, a one-week wait period, then followed by another three weeks of treatment or control. The intervention group received a hand-mediated energy healing technique called Ama Deus, and the control group received relaxation sessions. The intensity and frequency of the intervention/control were not described. During the first three weeks, 64% received the Ama Deus intervention and 36% received a relaxation intervention. After a one-week break, participants crossed over to receive the other intervention. Data were collected at the first meeting after enrollment (pretest), after completion of the first three weeks (midtest), and after the last session of the second three weeks (post-test).
A simple crossover design was used, with each patient acting as her own control.
Ama Deus Group 1 had significant reduction in state anxiety, and Group 2 demonstrated significant reduction in trait anxiety. Significant findings in depression reduction were revealed among Group 2 participants. It must be noted that no statistical values or types of statistical methods were reported to support these statements.
The study was poorly designed and reported, so no valid conclusion can be made.
Implications should only come from peer-reviewed, professionally written sources.
Weißflog, G., Brahler, E., Leuteritz, K., Barthel, Y., Kuhnt, S., Wiltink, J., . . . Beutel, M.E. (2015). Does psychodynamic short-term psychotherapy for depressed breast cancer patients also improve fatigue? Results from a randomized controlled trial. Breast Cancer Research and Treatment, 152, 581–588.
To describe the course of fatigue in depressed patients with breast cancer and determine the effect of psychodynamic therapy on fatigue
Patients were randomly assigned to the intervention or usual care group. Usual care patients were given written information about local counseling resources and given diagnostic information to provide to physicians who could initiate antidepressants or refer them to a psychotherapist. The experimental group was given dynamic short-term psychotherapy adapted to individual needs.
Overall MFI, physical fatigue, and reduced activity scores declined over time more in the psychotherapy group (p < 0.02). Depression, fatigue, and quality of life scores were significantly correlated (p < 0.01).
A short psychotherapeutic intervention to reduce fatigue in women with breast cancer was associated with a significant reduction in fatigue over time.
The results of this study showed that a psychotherapy intervention to reduce depression also had a positive impact on fatigue, and that fatigue, depression, and quality of life were correlated. These findings point to the importance of identifying and managing depression in patients with cancer not only to reduce depression but to have positive effects on symptoms of fatigue and quality of life.
Weinstein, S.M., Abernethy, A.P., Spruill, S.E., Pike, I.M., Kelly, A.T., & Jett, L.G. (2012). A spicamycin derivative (KRN5500) provides neuropathic pain relief in patients with advanced cancer: A placebo-controlled, proof-of-concept trial. Journal of Pain and Symptom Management, 43, 679–693.
To evaluate the safety and efficacy of KRN5500 for refractory neuropathic pain in patients with advanced cancer
KRN5500 is an agent that inhibits certain enzymes that may modulate aspects of neuropathic pain. Patients were randomly assigned to receive up to 8 weekly doses of the study drug or placebo. Patients were followed over 14 weeks. Patients were allowed to continue their usual pain treatments. KRN5500 was given in escalating IV doses ranging from 0.6–2.2 mg/m2. Study assessments were done at baseline, during weekly clinic visits, and at the end of 14 weeks.
This was a multisite, outpatient study conducted in the United States and Puerto Rico.
This was a double-blind, randomized, placebo-controlled, dose-finding trial.
This study provided some initial information regarding safety and efficacy of KRN5500 in a small cohort of patients.
The sample size was small, with fewer than 30 patients.
No conclusions can be drawn regarding the overall safety and efficacy of this drug. Further research in this area is needed.
Weinstein, S.M., Messina, J., & Xie, F. (2009). Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: A long-term, open-label safety study. Cancer, 115(11), 2571–2579.
To determine the long-term performance of fentanyl buccal tablet (FBT) in the treatment of breakthrough pain (BTP) in opioid-tolerant patients with chronic cancer pain; to assess the safety of FBT and how well patients tolerate it
In the screening phase, which lasted up to one week, patients underwent physical, laboratory, and neurologic examinations to determine whether they tolerated the test dose of FBT. In the titration phase, patients started with a therapy of 200 mcg FBT. Titration determined the effective dose. The study defined an effective dose as one that provided adequate relief from BTP within 30 minutes, without causing unacceptable adverse effects, for two episodes occurring at least four hours apart. Patients entered the 12-month maintenance phase when an effective dose of FBT was determined. In the maintenance phase, patients could take a second FBT.
Prospective repeated-measure, descriptive study
Patients tolerated FBT well for the study period, which lasted 12 months. The safety profile of FBT was favorable.
FBT is a favorable option for cancer patients with BTP and can be used safely over a long period.
Weinstein, C., Jordan, K., Green, S.A., Camacho, E., Khanani, S., Beckford-Brathwaite, E., . . . Rapoport, B. L. (2016). Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: Results of a randomized, double-blind phase III trial. Annals of Oncology, 27, 172–178.
To assess the efficacy and safety of a single dose of fosaprepitant (150 mg IV) combined with a 5-HT3 receptor antagonist and a corticosteroid versus a standard 5-HT3 receptor antagonist and a corticosteroid for the prevention of chemotherapy-induced nausea and vomiting (CINV)
Patients received fosaprepitant versus placebo with ondansetron plus dexamethasone on day 1. Oral ondansetron and dexamethasone were used. Patients who received fosaprepitant on day 1 received placebo medication on days 2–3, while those in the control group received ondansetron every 12 hours. Rescue medications were allowed at the discretion of the provider.
Complete response (CR) in delayed phase met superiority for the experimental fosaprepitant group versus the control group (p < 0.001) and for the overall phase (p < 0.001). Both regimens had high CR in the acute phase with no significant differences (p = 0.184). Fosaprepitant was superior to the control group for no vomiting in the overall phase (p < 0.001) and delayed phase (p < 0.001), and the time to first vomiting (p < 0.001). Fosaprepitant group had significantly more “no significant nausea” patients than the control group (p = 0.026).
Fosaprepitant demonstrated superior CR overall to oral ondansetron and dexamethasone alone in MEC regimens. These results are similar to results seen in highly emetogenic chemotherapy. Treatment differences of 0.1% in delayed and overall phases are seen to be clinically meaningful for patients.
Fosaprepitant may be safely used in patients receiving MEC. Further study is warranted.
Weinbroum, A.A. (2005). Superiority of postoperative epidural over intravenous patient-controlled analgesia in orthopedic oncologic patients. Surgery, 138, 869–876.
To compare patient-controlled analgesia (PCA) post-operative pain control by IV morphine versus epidural ropivacaine plus fentanyl analgesia in patients undergoing lower-body oncologic orthopedic procedures attributed to bone malignancy
Patients were assigned randomly. There was no control group.
Postoperative ropivacaine plus fentanyl via PCEA reduces pain better and affords better subjective feelings than morphine IV PCA after resection of bone malignancy carried out under combined general and epidural anesthesia.
Weinberg, R.S., Grecco, M.O., Ferro, G.S., Seigelshifer, D.J., Perroni, N.V., Terrier, F.J., . . . Alonso, D.F. (2015). A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients. SpringerPLUS, 4, 428-015-1217-y.
To determine safety and tolerability of increased doses of desmopressin (DDAVP) as well as what dose is most effective for cancer surgery, and to monitor the surgical bleeding, the plasma levels of the von Willebrand factor (VWF), and the circulating tumor cells (CTC).
Patients were divided into five groups of four. The patients received two IV infusions, first 30–60 minutes before surgery and again 24 hours later; if there were no dose-limiting toxicities noted, then the next group of patients had increased dosages. Desmopressin was diluted into 100 ml of normal saline. If no dose-limiting toxicity was reported, then the next cohort of patients were given higher doses of medication with the endpoint of a total dose at 2.0.
Of the 20 patients that were enrolled the study, two patients had reversible adverse events. One patient experienced hyponatremia, nausea, and grade 1 dyspnea one hour after the first dose of DDAVP. The second patient experienced grade 2 hypersensitivity reaction, and the medication was interrupted. The rate of the administration was slowed down in additional cohorts to prevent further reactions. A 50% reduction of intraoperative bleeding was noted with the increasing doses of DDAVP, measured by the number/weight of pads used during the procedure. There was also a higher VWF plasma levels and a noted postoperative decrease in CTC counts.
Using 2.0 (mcg/kg) dose of DDVAP was deemed as safe with two slow IV infusions before and after surgical procedures. Using higher doses of DDVAP showed a reduction in intraoperative bleeding, higher circulating VWF levels, and a decrease in CTC counts after the procedure.
Nurses administering DDVAP need to be aware of the potential reactions that may occur with the use of this medication.
Wehler, T.C., Graf, C., Mohler, M., Herzog, J., Berger, M.R., Gockel, I., ... Schimanski, C.C. (2013). Cetuximab-induced skin exanthema: Prophylactic and reactive skin therapy are equally effective. Journal of Cancer Research and Clinical Oncology, 139(10), 1667–1672.
To determine the effectiveness of several treatment options in decreasing cetuximab-induced skin exanthema in three study populations: the historic group (no standard skin treatment); the proactive skin therapy group; and the reactive skin therapy group
Retrospective analysis
Using this simple reactive skin protocol can prevent the exacerbation of cetuximab-induced follicular exanthema. This therapy can stabilize exanthema development. Results of the prophylactic skin treatment cohort showed equally effective, but not superior, results in preventing skin toxicity ≥ grade 2. Both groups B and C had lower therapy interruptions.
Nurses need to assess for exanthema, which generally develops within one to four weeks of initiating cetuximab. Prophylactic and reactive skin protocols are equally effective and may be easier to handle in practice. Both prophylactic and reactive skin treatments reduce higher grades of exanthema, which can lead to therapy cessation.
Webster, L., Jansen, J.P., Peppin, J., Lasko, B., Irving, G., Morlion, B., . . . Carter, E. (2008). Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: Results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain. Pain, 137, 428–440.
To assess the effectiveness and safety of alvimopan, a peripherally acting mu-opioid receptor antagonist, in patients with noncancer pain and opioid-induced bowel dysfunction.
Patients were randomized to one of four groups: oral alvimopan 0.5 mg twice daily (n = 130), oral alvimopan 1 mg daily (n = 133), oral alvimopan 1 mg twice daily (n = 130), or placebo capsules (n = 129).
Patients were instructed to discontinue laxative use. Rescue laxative medication (bisacodyl 10-30 mg) could be taken if the patient experienced discomfort with no bowel movement (BM) for four consecutive days. An interactive voice response system via touch-tone telephone was used for number of BMs, associated symptoms, rescue laxative use, opioid consumption, and pain intensity.
This was a phase IIb, randomized, double-blind, placebo-controlled, parallel-group study.
Oral alvimopan increases the frequency of SBMs and improves symptoms in adults on opioid pain regimens.
Oral alvimopan may be effective for the treatment of opioid-induced constipation in patients taking opioids for chronic pain and may improve opioid-induced bowel dysfunction symptoms. Use of alvimopan does not appear to compromise analgesia or induce opioid abstinence. Additional study is necessary to look at efficacy with an oncology population and determine long-term efficacy, as well as an optimal dosing regimen.
Weber, J.S. (2012). Practical management of immune-related adverse events from immune checkpoint protein antibodies for the oncologist. American Society of Clinical Oncology Educational Book, 174–177.
RESOURCE TYPE: Expert opinion
DATABASES USED: Not included
INCLUSION CRITERIA: Patients treated with ipilimumab
PHASE OF CARE: Active antitumor treatment
Low grade diarrhea (grade 1) should be treated symptomatically using loperamide, oral hydration, and electrolyte substitution. A colitis diet is recommended. Persistent or higher-grade diarrhea, bacterial or parasitic infections, viral gastroenteritis, or the first manifestation of an inflammatory bowel disease should be ruled out by an exam. Oral diphenoxylate hydrochloride and atropine sulfate four times a day and budesonide 9 mg daily are recommended. An endoscopy is recommended. For grade 3 or 4 diarrhea, treatment with ipilimumab should be permanently discontinued, and IV steroids and replenishment of fluid and electrolytes IV should be administered.
The information included was recommended in 2012. Since then, much more has been learned about the treatment of immune-related side effects of checkpoint inhibitors. Steroids are started early. This information seems out of date, and a more recent publication should be used for this specific type of side effect (immune-related colitis).
Patients who receive checkpoint inhibitors experience immune-related side effects that require immune suppression to manage. This is different from the management of diarrhea caused by other treatments for cancer. Nurses need to be aware of this specific cause of similar symptoms and be knowledgeable about its management.