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Doctor of Nursing Practice

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2 Doctor of Nursing Practice
Clinical Project Blaine L. Harrington, DNP-s, MSN, FNP

3 Management of Chemotherapy-Induced Peripheral Neuropathies (CIPN)
Doctor of Nursing Practice University of San Diego Focus in Oncology/Hematology Blaine Harrington, DNP-s, MSN, FNP Management of Chemotherapy-Induced Peripheral Neuropathies (CIPN) w/Daily Vitamin-E Supplementation Southwest Cancer Care Medical Group

4 Background Recent 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.

5 Scope of the problem Approximately 50-60% of patients receiving platinum or taxane-based agents may develop CIPN Neuropathies 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 effective Dose reduction or termination of therapy impacts patient outcome.

6 Definitions Peripheral Neuropathy: damage to the nerves of the peripheral nervous system resulting in numbness or tingling in the extremitie Vitamin-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.

7 Assumptions Use of Vitamin-E will reduce the incidence of CIPN by 30%
Patients will maintain compliance in taking Vitamin E, 600mg daily Patients will report any signs/symptoms of CIPN Chemotherapy RN’s will report any CIPN to NP. Vitamin-E will offer neuro-protection to reduce the occurrence of CIPN Use of Vitamin-E will reduce the incidence of CIPN by 30%

8 Evidence-based Model Advanced 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.

9 Problem Focused Triggers Knowledge Focused Triggers
The Iowa Model of Evidence-Based Practice to Promote Quality Care Problem Focused Triggers Knowledge Focused Triggers Priority for Organization Consider other triggers NO YES Develop Team

10 Assemble Relevant Research & Related Literature
Critique and Synthesize Research for Use in Practice Is there Sufficient Research? Research based to Guide Practice Base Practice on other Types of Evidence Conduct Research / Consult w/Experts

11 Is Change appropriate for adaption in Practice No Yes Institute Change
Continue to evaluate quality & monitor outcomes/ knowledge Monitor and Analyze Structure, Process, & Outcome Data Disseminate Results

12 Literature Review A 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.

13 Synthesis of Problem 50-60% 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.

14 Project Scope Summary Target Group: Adult Oncology Patients 1 2
Sub-Target: Receiving Platinum/Taxane Therapy 3 Goal: Reduce the occurrence of CIPN 4 Method: Daily Vitamin-E 600mg P.O.

15 Project 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.

16 Implementation 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.

17 Data 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.

18 Central Questions Will 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?

19 Findings Of 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.

20 Limitations of Study/Findings
Small sample size No guarantee that patients were 100% compliant with daily vitamin-E dosages Delays in the report of CIPN signs/symptoms Patient drop out (voluntary) of program and/or chemotherapy Death prior to completing chemotherapy Time constraints on completion of all study group patient chemotherapy regimens (some patients’ therapy cycles exceeded time-frame of study/academic deadlines).

21 Statistical 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).

22 Interpretation of Data

23 Statistical Analysis A 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 attributable to 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)

24 Interpretation of Data

25 Conclusions Neuropathy 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 CIPN Daily Vitamin E (600mg) should be utilized prior to and 3 months after completion of chemo-therapy If this can be achieved, patient quality of care and therefore quality of life will be measurably improved.

26 Further Evaluation and Recommendations
CIPN is more relevant than ever in oncology More well-designed trials re: CIPN are necessary to test the efficacy and safety of therapeutic methods and preventative supplements Physician/provider and patient education are essential in addressing CIPN/early intervention Further study/research pertinent to CIPN severity is needed

27 Further 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, and longitudinal follow-up of outcome measures

28 References Ajani,J.A., Welch, S.R., & Raber,M.N., et al (1990). Comprehensive criteria for Assessing therapy-induced toxicity. Invest,8,47-59 Argyrion,A.A., Chroni,E., Koutras,A., Ellul, J., Papaptropoulos, S., Katsoulas,G., et al. (2005). Vitamin E for prophylaxis against chemotherapy-induced neuropathy: a Randomized controlled trial. Neurologic, 64 (1), Cavaletti, G., & Zanna, C. (2002). Current status and future prospects for the treatment of Chemotherapy-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 ovarian Cancer with carboplatin/paclitaxel-based chemotherapy. Supportive care in Cancer, 13, MacDonald, D.R. (1998). Neurologic complications of chemotherapy. Neurologic Clinics, 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-Induced Neuropathies. Drug Safety, 29, Postma, T.J., & Heimans, J.J (2000). Grading of chemotherapy-induced peripheral Neuropathy. 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 and Ototoxicity. 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 fall In plasma antioxidants of cancer patients. Annals of Oncology,9,

29 For a copy of this presentation or more information go to: http://www

30 Southwest Cancer Care’s New Website (coming soon. ) at: http://www

31 Blaine L. Harrington, DNPs, MSN, FNP
Thank You! Blaine L. Harrington, DNPs, MSN, FNP


33 (for the last two years)
My Home Away from Home (for the last two years)

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