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The Use of 5 Fluorouracil Pumps in Gastro-Intestinal Patients - Research Paper Example

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This paper “The Use of 5 Fluorouracil Pumps in Gastro-Intestinal Patients” is an audit report of 5 fluorouracil pumps as used on gastro-intestinal patients, accounting for the information given to patients and the areas of information deficiency when administering the therapy…
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The Use of 5 Fluorouracil Pumps in Gastro-Intestinal Patients
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The Use of 5 Fluorouracil Pumps in Gastro-Intestinal Patients Background Information The use of 5 Fluorouracil (5FU) pumps in administering therapy to gastro-intestinal patients as a cancer control model, has replaced the earlier chemotherapy regime of capecitabine tablets. The adoption of this chemotherapy regime has been a success and has led to the realization of great improvements, especially for patients on out-patient treatment. According to Barbounis et al. (1989), the therapy has been a big success, as reported through a report entitled, The treatment of colorectal cancer and other malignancies with continuous infusion of 5-fluorouracil. The authors reported a study involving 26 patients suffering from gastrointestinal cancers and other epithelial-related conditions. These subjects were administered to continuous intravenous infusion of the medication using a portable pump. From the 26 observed patients who were placed under continuous observation, four realized full remission, another four showed a partial response to the therapy. From 12 of the patients, the disease remained stable. The response rate from the study was 33%. Twenty from the total number showed significant improvement as reflected from their overall quality of life and performance status after the therapy. The information showed a 9.5 months median survival. The study showed that continuing the infusion of 5-fluorouracil results in palliative value, from patients suffering from gastrointestinal or other neoplasma condition, related to epithelial origin. In administering the therapy, the usage of portable pumps makes the model cost effective and a practical outpatient model of treatment for these patients. This paper is an audit report of 5 fluorouracil (5FU) pumps as used on gastro-intestinal patients, accounting for the information given to patients and the areas of information deficiency when administering the therapy (Cascinu et al., 1999). Background information on the use of 5 fluorouracil (5FU) pumps The service evaluation was instigated by the Forever Healthy cancer support, which is a cancer support agency operating in the US and also extending its supports services and information provision to many other different regions across the world. The reasons for undertaking the service evaluation included the information gaps evident in the usage of the model, despite the fact that the area has been studied extensively. An example of the deficiencies in information includes that communicated to the patients as well as the team administering this therapy. Some of the areas of information deficiency include the lack of knowledge on how to control the side effects resulting from the therapy. For instance, an overdose of 5-FU results in severe side effects such as neutropenia, diarrhea, and hand/foot syndrome. On the other hand, a low dosage of the medication does not produce any results or therapeutic effect. Further, there is a possibility of individual therapeutic balance existing between the benefits and the side effects expected. As a result, based on understanding of the expected benefits and the effects of this therapy on the users, the organization saw that there is a need to offer more information to the patients. Based on the better information, they will make better decision and more logical choices when using the service, as opposed to the current use – which may be affected by the lack of comprehensive information. Based on the information delivered to the users, more information on the individual-based application of the therapy, as well as the benefit-threats balance, more areas of information will be uncovered, leading to better results from the therapy. For instance, more information on the usage of the administered dosage depending on the body characteristics of the patients will be of great importance to the usage of the therapy. For instance, these characteristics affect the distribution, absorption, excretion and the metabolism of the dose, which may indicate the need for dosage adjustment (Arkenau et al., 2005; Chiara et al., 1998; Comella et al., 2002). The use of 5 fluorouracil (5FU) pumps is among the oldest and one widely used chemotherapeutic model, which has seen the development of different infusion schedules. For example, in the US, the bolus regimen is widely used while in France, the Folfox4 model is greatly preferred. The current knowledge on the usage of the therapy shows that 5-FU disappears quickly from the plasma. The half-life of the medication is approximated at between 10 and 20 minutes. In the area of body clearance, it is noted that there is a variation depending on the schedule of administration. For continuous infusion, the level is 5-58 l/min, which is higher than that from other models of administration, for instance, bolus application. In the area of the right dosage during the administration of the therapy, there are areas of information deficiency regarding the dosage balance – to avoid the overdose side effects, but manage to realize the expected results from the therapy. Further information gaps are evident in the area of the individual dosage balance specifications towards striking a balance between realizing the expected therapeutic results and avoiding the side effects resulting from over dosage (Comella et al., 2006; Cunningham et al., 1984; Falcone et al., 1998; Findlay et al., 1994). From this service evaluation, more light will be shed on these areas of information gaps, especially in the areas of the right dosage for different patients, as well as the best way of establishing the balance of dosage from different patients. From the service evaluation, more information will also be collected from the users of the service, who will offer first-hand information on how to strike the balance for different patients, as well as other factors that may affect the therapy, as could be told from their experiences. The service will also shed more light on areas of conflicting knowledge among the practitioners of the service, which will offer information on the areas requiring more research and medical study (Findlay et al., 1994). The aims of the service evaluation The aims of this service evaluation include offering information to fill the information gaps existing in the area of administering the service, especially with regard to the needs of the different patients. An example here is establishing a dosage level for the therapy. The study will also expose the adjustments or the differences to be affected in the administration of the service, to ensure that all patients are served effectively. These answers will be drawn from a study of the opinions of the patients taken through the therapy, as well as the medical practitioners who have had a one-on-one experience with the administration of the service. The service evaluation will also expose areas that require more research, towards the realization of more effective administration of the service. The study will also explore whether the improvement of the disease could come back after an effective therapy (Yamao et al., 1995). Service Evaluation Objectives: Primary Objective To identify the causes of information gaps, for instance, in the area of dosage allocation Secondary objective To identify the effect of individual characteristics on dosage balance evaluation To explore the information that can be collected from different parties: patients and doctors, towards correcting the information gaps identified The study will also explore whether the patient’s condition could revert after effective therapy Service evaluation design The conceptual model of the study will place focus on the information level offered to patients under this therapy, especially in the area of information gaps, the effect of individual differences, and the level of exposure before the therapy is administered. The study will take the form of a prospective cohort inquiry, as it will follow the therapy and improvement tracks of patients exposed to the therapy. The factors of differentiation include level of dosage, level of knowledge prior to therapy, and the effects of personal variations. The study team will act as observational participants, working through the medical personnel at the hospital under study to recruit and control the study group. The patients eligible for the study will include those that are aged 18 and over and those diagnosed with gastro-intestinal cancer. The eligible patients should not have undergone systemic chemotherapy or radiation therapy in the past, apart from the usage of 5 fluorouracil (5FU) pumps, at the study hospital within the period between three months before the study and three months after the start of the study. The last exclusion criterion was that the individuals eligible for the study must have been tested negative, for pregnancy, in the case they are female. The study will be extensively informed by past studies – both empirical and theoretical, showing areas of information gaps. The variables for the study include the information offered to patients before therapy, the different results and individual characteristics related effects from therapy exercises, knowledge level regarding the therapy, and the cases of reverted cancer symptoms after effective therapy. For instance, patients informed about the effect of their personal characteristics on dosage and the possible side effects or ineffectiveness of the therapy will show the different levels of the information given to the patients, prior to therapy. The information given will mainly be qualitative in nature; therefore, it will take the form of descriptions (Tan et al., 1996; Wein et al., 2001). Eligibility for inclusion in the service evaluation The patients eligible for the SE will include those that are aged 18 and over and those diagnosed with gastro-intestinal cancer. Eligible patients should not have undergone systemic chemotherapy or radiation therapy in the past, apart from the usage of 5 fluorouracil (5FU) pumps, at the study hospital within the period between three months before the study and three months after the start of the study. Prior to the SE, the eligible, chosen subjects will be taken through a biopsy of the cancerous growths and tumors, taken through a complete physical evaluation, and taken through urine and blood testing to evaluate their health status. Female patients of childbearing age will be checked for pregnancy and every patient should keep a calendar of any medication they are taking, apart from the therapy. This includes aspirin use (Tralongo et al., 1995). a) a) Inclusion criteria Eligible patients will have the following characteristics i. They should be aged 18 and over ii. They should have been diagnosed with gastro-intestinal cancer iii. They should not have undergone systemic chemotherapy or radiation therapy in the past, apart from the usage of 5 fluorouracil (5FU) pumps, at the study hospital within the period between three months before the study and three months after the start of the study. And they should have undergone the different tests, including a complete physical evaluation, urine and blood testing to evaluate their health status, pregnancy testing for female patients and should have observed the keeping of a calendar of any medication they are taking, apart from the therapy, including aspirin intake. iv. The patients that had reported 3 months before initialization of the research, and those that would report 3 months after the start of the study; time of recruitment is 6 months in total. b) Exclusion criteria i. Patients with a past history of cardiac arrest and stroke ii. Those suffering from diabetes or high blood pressure, and those of unsound mental stability iii. Patients of poor performance status and those diagnosed with other serious medical conditions. Planned methodology Data Collected between (dates) The study subjects will be administered with the standard 2-day regimen of the prescribed chemotherapy. The medication compound used at the hospitals of study is bolus regimen. The regimen will be administered on day 1 and day 2 every week for a continued 12, 2 week cycles. As stated earlier, the patients considered for the study are those that reported to the hospital 3 months before, and those that will report to the hospital 3 months after the start of the study. After this duration, recruitment of patients will be ceased. Medication will be administered before the chemotherapy, as this will help prevent the incidences of vomiting and nausea. All of the chemotherapy drugs will be administered using the 5 fluorouracil pumps. Oxalipation and leucovorin are administered consecutively for two hours, followed by the 5-FU compound, which will be administered as a quick infusion, using the portable pump for 46 hours after the start of the administration (Streit et al., 1997). The central review after the medication: the patient’s tumor tissue will be sent for examination at the designated laboratory. The review will check whether patients are subjected to low-risk or high risk therapy classification. Six weeks after continued exposure to the therapy, the patients will be taken through the following tests to evaluate their health status and monitor the incidence of the treatment’s side effects, which may have shown since their last therapy. On average, 5 tea spoons of blood will be taken to carry out the tests. When through with the treatment – the high-risk class and those under observation (low-risk class) will be taken through a series of the following tests, which are part of a standard follow-up care (Streit et al., 1997). High-risk group: routine blood test and physical evaluation every three months, for 18 months, after the therapy’s completion. The tests will then be continued for an observational duration of three years. During each test, 1 tea spoon of blood will be taken for the tests to be run at each time the patient is seen for the tests. Among the low-risk patients, blood tests and routine physical tests will be done after every three months, for a period of 3 years. After this duration, tests will be run after every six months, followed by yearly testing for a period of 5 years. Like the previous group, one teaspoonful of blood will be taken during every session of testing (Sobrero et al., 1995). Data Source(s) to be used The sources of data to inform the study will include the medical records of past administration of the therapy, patients’ registers covering the duration of study, laboratory reports and the progress reports drawn from each patient throughout the time of study. To inform the study will also be any documentation of medical recommendations done to the patients under study (Link et al., 2004; Mosconi et al., 2000; Regazzoni et al., 1996). Statistical considerations Endpoints The statistical considerations made here include randomization, which will provide opportunity for statistical comparisons between study groups, as well as aid in eliminating selection bases during the assigning of treatment. Patients will be stratified into subgroups, which are subjected to a range of randomization. This will help strengthen the comparability of the different groupings. Through stratification, the researchers will ensure that there is an appropriate generalizability by including relevant segments of a population study group. In the area of randomization, the patients will be split into three different groups, which will offer information on information deficiencies, information levels, the influence of personal characteristics on the therapy, and any symptoms of the reversal of the condition. Through stratification, the doctors will also offer information on the data collection areas as first-hand witnesses of the patient’s condition and changes (Hill et al., 1995; Hofheinz et al., 2002; Kotake et al., 1994; Leichman et al., 1996). Analysis methods The researchers will use the mixed logit model to examine the level of information offered to the patients before therapy. The model will also help in capturing the information held by the different parties: doctors and patients, and the progress reports will offer information on whether there was the possibility of reversal of the cancerous development. The data sets will be collected as panel data. For instance, the same patient was studied over the duration of study. The data sets collected from the same patients were correlated. It is important to note that the model is a nonlinear framework, thus the independent variables are categorical. As a result, the natural exponential value of the estimated coefficients was checked, as this gave odds ratio from the inferences and the associations established (Greene, 2004). All the patients covered by the research, will be incorporated in the study population’s analysis. The final analysis will be administered after one year, then after 3 years, and the final analysis will be administered 5 years after the start of the study (Hansen et al., 1991; Hartmann et al., 1998; Hegewisch-Becker et al., 2002). Sample size The study group is selected from the incoming patients suffering from the conditions. The sample selection exercise will mainly be known through exclusion and inclusion criteria, as the researchers anticipate using the most representative sample – a sample that is fully representative of the situation of the patients going through the therapy. The sample was drawn from the gastro-intestinal patients register, which had 120 patients at the times of start of the study. Of the 120, 70 met the inclusion criteria and thus were chosen for the study. During the three months after the start of the study, another 70 patients were registered. Among the 70, 40 met the exclusion criteria. From the initial and the new sample groups, the study had a total of 110 subjects. From the study sample, a 98.8% feedback rate was registered. The sample covers patients registered from January 1 to June 30, 2012. The patients were recruited from the GI patients’ register of the patients receiving 5FU at the Hakin hospital (Gebbia et al., 1999; Guglielmi et al., 1998; Hansen et al., 1989). Study organization The research group took an observation-based study and, therefore, will not be directly engaged in the control or the administration of the therapy. They will draw all the information from the medical teams at the hospital. The recruitment will be carried out by the research team together with the medical team, while the collection and the entry of data will be carried out by the research team. All treatment processes will be administered by the medical team at the hospital. Tracking of out-patients will be carried out by the research team through the medical team. The research team will have very few cases of contact with the subjects of the study. Data handling will be done cooperatively by the medical and the research team. Data storage will be done by both teams: the medical team will store the data at the hospital’s registry storage section, while the research team will store the data as backup filing in the support institute’s server system. These include the questionnaires used for the study (Findlay et al., 1994; Garcia-Giralt et al., 1996; Guglielmi et al., 1996). Data storage and data handling State here: Questionnaires will be stored eg in a locked cabinet, in a specified room on site References Arkenau, H., Rettig, K. and Porschen, R., 2005. Adjuvant chemotherapy in curative resected colon carcinoma: 5-fluorouracil/leucovorin versus high-dose 5-fluorouracil 24-h infusion/leucovorin versus high-dose 5-fluorouracil 24-h infusion. Int J Colorectal Dis, 20 (3), pp. 258-61. Barbounis, V., Kalofonos, H. P., Munro, A., McKenzie, C., Sackier, J. and Epenetos, A., 1989. Treatment of colorectal cancer and other malignancies with continuous infusion of 5- fluorouracil. Anticancer Res, 9 (1), pp. 33-39. Cascinu, S., Aschele, C., Barni, S., Debernardis, D., Baldo, C., Tunesi, G., Catalano, V., Staccioli, M., Brenna, A., Muretto, P. and Catalano, G., 1999. Thymidylate synthase protein expression in advanced colon cancer: correlation with the site of metastasis and the clinical response to leucovorin-modulated bolus 5-fluorouracil. Clin Cancer Res, 5 (8), pp. 1996-9. Chiara, S., Nobile, M., Vincenti, M., Lionetto, R., Gozza, A., Barzacchi, M., Sanguineti, O., Repetto, L. and Rosso, R., 1998. Advanced colorectal cancer in the elderly: results of consecutive trials with 5-fluorouracil-based chemotherapy. Cancer Chemother Pharmacol, 42 (4), pp. 336-40. Comella, P., Casaretti, R., De Rosa, V., Avallone, A., Izzo, F., Fiore, F., Lapenta, L., and Comella, G., 2002. 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Continuous systemic 5-fluorouracil infusion in advanced colorectal cancer: results in 91 patients. J Surg Oncol, 40 (3), pp. 177-81. Hansen, R., Moynihan, T., Beatty, P., Quebbeman, E., Libnoch, J., Schulte, W. and Anderson, T., 1991. Continuous systemic 5-fluorouracil infusion in refractory prostatic cancer. Urology, 37 (4), pp. 358-61. Hartmann, J., Köhne, C., Schmoll, H., Daikeler, T., Kanz, L. and Bokemeyer, C., 1998. Is continuous 24-hour infusion of 5-fluorouracil plus high-dose folinic acid effective in patients with progressive or recurrent colorectal cancer? A phase II study. Oncology, 55 (4), pp. 320-5. Hegewisch-Becker, S., Gruber, Y., Corovic, A., Pichlmeier, U., Atanackovic, D., Nierhaus, A. and Hossfeld, D., 2002. Whole-body hyperthermia (41.8 degrees C) combined with bimonthly oxaliplatin, high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer: a phase II study. Ann Oncol, 13 (8), pp. 1197-204. Hill, M., Norman, A., Cunningham, D., Findlay, M., Watson, M., Nicolson, V., Webb, A., Middleton, G., Ahmed, F. and Hickish, T et al., 1995. Impact of protracted venous infusion fluorouracil with or without interferon alfa-2b on tumor response, survival, and quality of life in advanced colorectal cancer. J Clin Oncol, 13 (9), pp. 2317-23. Hofheinz, R., Hartung, G., Samel, S., Hochhaus, A., Pichlmeier, U., Post, S., Hehlmann. R. and Queisser, W., 2002. High-dose 5-fluorouracil / folinic acid in combination with three- weekly mitomycin C in the treatment of advanced gastric cancer. A phase II study. Onkologie, 25 (3), pp. 255-60. Kotake, K., Koyama, Y., Nasu, J., Ando, J., Ozawa, I. and Ogata, Y., 1994. Treatment of advanced colorectal cancer with long-term continuous infusion of 5-fluorouracil. Gan To Kagaku Ryoho, 21 (1), pp. 47-52. Leichman, C., Leichman, L., Spears, C., Rosen. P., Jeffers, S. and Groshen, S., 1996. Prolonged continuous infusion of fluorouracil with weekly bolus leucovorin: a phase II study in patients with disseminated colorectal cancer. J Natl Cancer Inst, 6 (1), pp. 41-4. Link, K., Happich, K., Schirner, I., Jüngert, B., Brückl, V., Männlein, G., Brückl, W., Merkel, S., Göhl, J., Hohenberger, W., Hahn, E. and Wein, A., 2004. Palliative second-line treatment with weekly high-dose 5-fluorouracil as 24-hour infusion and folinic acid (AIO) plus oxaliplatin after pre-treatment with the AIO-regimen in colorectal cancer (CRC). Anticancer Res, 24 (1), pp. 385-91. Mosconi, S., Cascinu, S., Zaniboni, A., Catalano, V., Giordani, P., Beretta, G., Martignoni, G., Pancera, G., Baldelli, A., Poletti, P., Curti, C. and Labianca, R., 2000. The value of oxaliplatin in combination with continuous infusion +/- bolus 5-fluorouracil and levo- folinic acid in metastatic colorectal cancer progressing after 5FU-based chemotherapy: a GISCAD (Italian Group for the Study of Digestive Tract) cancer phase II trial. Tumori, 86 (6), pp. 465-9. Regazzoni, S., Pesce, G., Marini, G., Cavalli, F. and Goldhirsch, A., 1996. Low-dose continuous intravenous infusion of 5-fluorouracil for metastatic breast cancer. Ann Oncol, 7 (8), pp. 807-13. Sobrero, A., Aschele, C., Guglielmi, A., Mori, A., Tixi, L., Bolli, E., Rosso, R., Mammoliti, S., Rollandi, G. and Bertoglio, S. et al., 1995. Schedule-selective biochemical modulation of 5-fluorouracil: a phase II study in advanced colorectal cancer. Clin Cancer Res, 1 (9), pp. 955-60. Streit, M., Jaehde, U., Stremetzne, S., Ridwelski, K., Kerz, H., Strohbach, F., Hohenberger, P., Zwiebel, F., Hebart, H., Böthig, R., Kairies, M., Zillig, D., Schuchmann, S., Warnecke, S., Thiel, E. and Kreuser, E., 1997. Five-day continuous infusion of 5-fluorouracil and pulsed folinic acid in patients with metastatic colorectal carcinoma: an effective second- line regimen. Ann Oncol, 8 (11), pp. 163-5. Streit, M., Jaehde, U., Stremetzne, S., Ridwelski, K., Kerz, H., Strohbach, F., Hohenberger, P., Zwiebel, F., Hebart, H., Böthig, R., Kairies, M., Zillig, D., Schuchmann, S., Warnecke, S., Thiel, E. and Kreuser, E., 1997. Five-day continuous infusion of 5-fluorouracil and pulsed folinic acid in patients with metastatic colorectal carcinoma: an effective second- line regimen. Ann Oncol, 8 (11), pp. 163-5. Tralongo, P., Di Mari, A., Scibilia, G., Bosco, V., Giudice, A., Respini, D. and Failla, G., 1995. Prolonged 5-fluorouracil infusion in patients with metastatic colon cancer pretreated with bolus schedule of the same agent. Anticancer Res, 15 (2), pp. 635-8. Tan, E. and Ang, P., 1996. Fluorouracil continuous infusion in metastatic colorectal cancer. Ann Acad Med Singapore, 25 (5), pp. 748-51. Wein, A., Riedel, C., Köckerling, F., Martus, P., Baum, U., Brueckl, W., Reck, T., Ott, R., Hänsler, J., Bernatik, T., Becker, D., Schneider, T., Hohenberger, W. and Hahn, E., 2001. Impact of surgery on survival in palliative patients with metastatic colorectal cancer after first line treatment with weekly 24-hour infusion of high-dose 5-fluorouracil and folinic acid. Ann Oncol, 12 (12), pp. 1721-7. Yamao, T., Shimada, Y., Kondo, H., Shirao, K., Yokota, T., Sugano, K., Saito, D., Ohkura, H. and Yoshida, S., 1995. Clinical trial of continuous infusion of 5-fluorouracil using an ambulatory pump for metastatic colorectal cancer. Jpn J Clin Oncol, 25 (2), pp. 46-50. Read More
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The literary review “the use of Insulin Pumps in Children” demonstrates safety, convenience, and other benefits of this therapy as an adequate treatment for type 1 diabetes in young patients.... The results of the assessment tend to indicate that a need exists for further large sample longitudinal studies on the use of insulin pump therapy in children because current research is characterized by small samples.... However, nearly all studies agree that although the use of insulin pumps does appear to provide superior hypoglycemic control in users and a better fit for lifestyles as well as psychological uplift for the patient and caregivers, it is necessary to ensure that those who are considered for insulin pump therapy are capable of understanding and dealing with the pumps....
24 Pages (6000 words) Literature review
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