2Doctor of Nursing Practice Clinical ProjectBlaine L. Harrington, DNP-s, MSN, FNP
3Management of Chemotherapy-Induced Peripheral Neuropathies (CIPN) Doctor of Nursing PracticeUniversity of San DiegoFocus in Oncology/HematologyBlaine Harrington, DNP-s, MSN, FNPManagement ofChemotherapy-InducedPeripheral Neuropathies (CIPN)w/Daily Vitamin-E SupplementationSouthwest Cancer Care Medical Group
4BackgroundRecent advances in chemotherapy TX for malignant disease have prolonged survival rates in cancer patients.Unfortunately, the nervous system has been affected in the process, causing chemotherapy-induced neurotoxicity/peripheral neuropathy.These neurotoxic insults can be a result of using platinum and taxane based agents.Typically associated with axonal degeneration.Side-effect can be irreversible as well as debilitating.Function and ADL’s can be affected.
5Scope of the problemApproximately 50-60% of patients receiving platinum or taxane-based agents may develop CIPNNeuropathies are not easily treated and add to the patient’s distress/discomfort and can be permanently debilitating.Delayed reporting of symptoms further exacerbates problem.Protective treatment strategies have not been effectiveDose reduction or termination of therapy impacts patient outcome.
6DefinitionsPeripheral Neuropathy: damage to the nerves of the peripheral nervous system resulting in numbness or tingling in the extremitieVitamin-E: Antioxidant that neutralizes free radicals and protects cell membranes. It is suggested to be neuro-protective.Platinum/Taxane: Chemical agents used to treat cancer intravenously. Agents work by binding to DNA of tumor cells.
7Assumptions Use of Vitamin-E will reduce the incidence of CIPN by 30% Patients will maintain compliance in taking Vitamin E, 600mg dailyPatients will report any signs/symptoms of CIPNChemotherapy RN’s will report any CIPN to NP.Vitamin-E will offer neuro-protection to reduce the occurrence of CIPNUse of Vitamin-E will reduce the incidence of CIPN by 30%
8Evidence-based ModelAdvanced practitioners use evidence-based practice models to implement necessary changes to practice guidelines and patient care.The model most supportive to my project plan was the Iowa Model.The Iowa model was successfully implemented in 1994, and has been used internationally to infuse research into practice to improve quality of care.Utilizes a multi-disciplinary approach.
9Problem Focused Triggers Knowledge Focused Triggers The Iowa Model ofEvidence-Based Practice to Promote Quality CareProblem Focused TriggersKnowledge Focused TriggersPriority forOrganizationConsider othertriggersNOYESDevelop Team
10Assemble Relevant Research & Related Literature Critique and Synthesize Research for Use in PracticeIs there SufficientResearch?Research based toGuidePracticeBase Practice on otherTypes of EvidenceConductResearch / Consultw/Experts
11Is Change appropriate for adaption in Practice No Yes Institute Change Continue toevaluate quality &monitor outcomes/knowledgeMonitor and AnalyzeStructure, Process, &Outcome DataDisseminateResults
12Literature ReviewA literature review was completed using search engines such as: MEDLINE, Cochrane, PubMed, American Cancer Society, and NCCN.Key words utilized: CIPN, Vitamin-E in prevention of CIPN, Platinum based agents in CIPN, peripheral neuropathy, and Vitamin-E neuroprotection.Evidence indicates that CIPN may be decreased with daily 600mg supplementation of Vitamin E when undergoing platinum and taxane agent infusions.
13Synthesis of Problem50-60% of adult patients receiving platinum/taxane based chemotherapy may develop CIPN…The purpose of this project was to determine the efficacy of daily Vitamin-E (600mg) in reducing the rate of these occurrences of CIPN.
15Project Implementation/Methods Chart Reviews were conducted on 35-patient study group selection (i.e. adult oncology patients receiving platinum/taxane based agents with no history of peripheral neuropathy or DM were enrolled).Written consent was obtained from each patient.Patients completed questionnaire (re: neuropathy history) prior to/as part of enrollment.Neuro assessments and evaluations were performed for each patient.Supplies of Vitamin-E 600mg were provided to patients for daily regimen.Patients were evaluated at each f/u visit for any signs or symptoms of CIPN.
16Implementation Logistics Obtained support of collaborating physicians in the use of 600mg daily Vitamin-E regimen.Developed a practice guideline to include the use of Vitamin-E with platinum/taxane based agents.Modified chemotherapy orders to include Vitamin-E 600mg.
17Data and Cost Analysis 35 patients were tracked in the study 15 patients actively participated in the Vitamin E Study (maintained daily Vitamin E regimens)Vitamin E was provided for patients at an estimated cost of $ (supplied by B.Harrington).Provider time was included in chemo-therapy consent visit.
18Central QuestionsWill the use of Daily Vitamin-E reduce the occurrence of CIPN in adult oncology patients? Research indicates a 30% reduction in occurrence.Will patients be fully complaint/diligent in taking their daily Vitamin-E dosages?Will patients report early s/s of CIPN allowing for early management and intervention?
19FindingsOf the 35 patients who met study guidelines, 16 patients, or 45.7% developed CIPN (grade 1-2).Of the 15 patients enrolled to take the 600mg daily Vitamin E, two (2) patients, or 12.5%, developed CIPN (grade 1-2).Clear indication of efficacy was observed.
20Limitations of Study/Findings Small sample sizeNo guarantee that patients were 100% compliant with daily vitamin-E dosagesDelays in the report of CIPN signs/symptomsPatient drop out (voluntary) of program and/or chemotherapyDeath prior to completing chemotherapyTime constraints on completion of all study group patient chemotherapy regimens (some patients’ therapy cycles exceeded time-frame of study/academic deadlines).
21Statistical Analysis (Summary) A 2x2 chi-square analysis was conducted to assess the relationship of the study group (Chart review vs. Vit-E), and CIPN (yes vs. no).A significant result was obtained:χ2 (2) = 12.84, p = .0003, phi = -.507(representing a large effect size).Per the clustered bar chart (next slide), we see that proportionally more patients (86.78%, n = 13) in the Vit-E group developed fewer occurrences of CIPN, where as those in the (general) chart review only group had a higher occurrence of chemo-therapy induced neuropathy (68.6%, n = 24).
23Statistical AnalysisA one-way ANOVA (or “analysis of variance”) was conducted to assess between-group differences on neuropathy grade.A significant result was obtained:F (1, 48) = 11.35, p = .001 (η2 = .191),which means that 19.1% of the variation in grade is attributableto between-group differences.The chart review group obtained a higher mean (M = 1.23, SD = 1.03) than the Vitamin E group: (M = .27, SD = .594)
25ConclusionsNeuropathy is distressing/debilitating for patients and difficult to treat, and occurs at high level of frequency.Vitamin E (600mg) taken daily is a very simple preventative measure, yet substantially effective in reducing CIPNDaily Vitamin E (600mg) should be utilized prior to and 3 months after completion of chemo-therapyIf this can be achieved, patient quality of care and therefore quality of life will be measurably improved.
26Further Evaluation and Recommendations CIPN is more relevant than ever in oncologyMore well-designed trials re: CIPN are necessary to test the efficacy and safety of therapeutic methods and preventative supplementsPhysician/provider and patient education are essential in addressing CIPN/early interventionFurther study/research pertinent to CIPN severity is needed
27Further Evaluation and Recommendations (cont’d). To advance science regarding effective prevention and treatment strategies for CIPN, specifically designed randomized clinical trials are needed… using:appropriate oncology populations,adequate sample sizes,standardized measurement procedures, andlongitudinal follow-up of outcome measures
28ReferencesAjani,J.A., Welch, S.R., & Raber,M.N., et al (1990). Comprehensive criteria forAssessing therapy-induced toxicity. Invest,8,47-59Argyrion,A.A., Chroni,E., Koutras,A., Ellul, J., Papaptropoulos, S., Katsoulas,G., et al.(2005). Vitamin E for prophylaxis against chemotherapy-induced neuropathy: aRandomized controlled trial. Neurologic, 64 (1),Cavaletti, G., & Zanna, C. (2002). Current status and future prospects for the treatment ofChemotherapy-induced peripheral neurotoxicity. European Journal of Cancer,38,Hilpert,F., Stahle, A.,Tome, O,. Burges, A., Rossner,D., Spathe, K., et al. (2005).Neuroprotection with amifostine in the first-line treatment of advanced ovarianCancer with carboplatin/paclitaxel-based chemotherapy. Supportive care inCancer, 13,MacDonald, D.R. (1998). Neurologic complications of chemotherapy. NeurologicClinics, 9,Marrs,J., & Newton, S. (2003). Updating your peripheral neuropathy “know how”Clinical Journal of Oncology Nursing,7,Pace, A., Savarese, A., Picardo, M., Maresca, V., pacetti, U., Del Monte,G., et al. (2003).Neuroprotective effect of vitamin E supplementation in patients treated with cisplatin chemotherapy. Journal of clinical Oncology,21(5),Peltier, A.C., & Russell, J.W (2006). Advances in Understanding Drug-InducedNeuropathies. Drug Safety, 29,Postma, T.J., & Heimans, J.J (2000). Grading of chemotherapy-induced peripheralNeuropathy. Annals of Oncology, 11,Quasthoff, S., & Harding, H.P. (2002). Chemotherapy-induced peripheral neuropathy.Journal of Neurology, 249, 9-17.Vitamin E in the neuroprotection of Cisplatin induced peripheral neurotoxcity andOtotoxicity. Journal of Clinical Oncology, 25 (185). (June 20 suppl).Weijl, N.I., Hopman, G.D., Wipkink-Bakker, A.,Lentjes, E.G.,Berger, H.M.,Cleton FJ., et al. (1998). Cisplatin combination chemotherapy induces a fallIn plasma antioxidants of cancer patients. Annals of Oncology,9,
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31Blaine L. Harrington, DNPs, MSN, FNP Thank You!Blaine L. Harrington, DNPs, MSN, FNP