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    Ray Robson Lu Ju Chen

    07/251657/KU/12248

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    Background Nasopharyngeal carcinoma (NPC) is an Epstein-Barr

    virus-associated cancer

    highly prevalent in Southeast Asia and especiallysouthern China - its occurrence can reach about a 100-fold higher compared with other populations not at

    risk. (Li et al, 2007)

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    In Indonesia, especially central Java, undifferentiated

    NPC (WHO type III) is one of the most commoncancers.

    For instance NPC is ranked 1 in males and 3 in femalesin the Yogyakarta province, with regional villagesrepresenting hot spots of NPC incidence.

    (Fachiroh et al, 2006)

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    Nasopharyngeal carcinoma has been treatedpreferably treated with chemotherapy andradiotherapy due to the anatomic limitation and itstumors high degree ofradiosensitivity andchemosensitivity.

    (Lin et al, 2002)

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    Problem Statement Patients that underwent cancer treatment usually suffer

    from its side effects.

    Weight loss is one of the most common toxicity faced bythe patients.

    Weight loss could lead to reduced response totreatment, decrease quality of life, and the survival.

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    The possible risk factors affecting weight loss that we

    are concerned are:

    Age Gender

    Stomatitis

    Nausea

    Vomiting

    Diarrhea

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    Research QuestionWhat is the prevalence and risk factors of weight loss

    in the NPC patients who received concurrentchemoradiotherapy?

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    Objective To research the risk factors of weight loss and its

    significance

    To find out the prevalence of weight loss among NPCpatients based on their clinical characteristics

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    Literature Review Nasopharyngeal carcinoma (NPC), a malignant tumor

    arising in the epithelial lining of the nasopharynx

    According to WHO:

    Stage III: cancer has spread to the lymph nodes on oneor both side of neck and may have spread to the soft

    tissues of throat or nearby bones. Stage IV, cancer has spread to either facial nerve, lower

    portion of throat, bones of skull or to the lymph node ofthe neck.

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    Literature Review Sign and symptoms of NPC:

    A lump in your neck caused by a swollen lymph node

    Bloody discharge from your nose Nasal congestion on one side of your nose

    Hearing loss in one ear

    Frequent ear infections

    Headaches Double vision

    Face and neck pain

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    Literature Review Patients with NPC undergo pretreatment staging

    evaluations: clinical examination for head and neck

    computed tomography (CT) scan or magnetic resonanceimaging from the skull base to the whole neck

    complete blood count with differential count, plateletcount, and biochemical profile and Epstein-Barr virus

    serology

    For pathologic diagnosis, patients will undergo biopsyto obtain specimen.

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    Conceptual FrameworkRisk Factors of Weight Loss:AgeGenderStomatitisNausea

    VomitingDiarrhea.

    Weight LossRace / EthnicEducationOccupation / Income

    Sample population

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    Hypothesis There is a significant difference in weight loss in NPC

    patient based on their different clinical characteristics andrisk factors

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    Methodology Cross Sectional Study

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    Population and Sample Target population is patients with NPC Stage III and

    Stage IV in Yogyakarta

    The population scope includes all NPC patientsreceiving concurrent chemoradiotherapy in TulipIntegrated Cancer Clinic, Dr. Sardjito Hospital

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    Minimal Sample Size Sample size is calculated using :

    =

    1

    +

    + 1 11

    +2 12

    (12) q1 = proportion of subjects in group 1

    q2 = proportion of subjects in group 2

    N

    = minimal sample size P = q1 P1 + q2 P2

    By inserting q1=0.5, q2=0.5, P1=0.8, P2=0.5, P=0.65

    Minimal sample size, N = 80

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    Operational Definition Concurrent chemoradiotherapy is a chemotherapy

    that consisted of cisplatin at a dose of 40 mg/m2 onday 1 in each weeks, repeated for 7 cycles, and followedby the external beam radiotherapy (EBRT)Radiotherapy used is a cobalt-60 g-ray or linearaccelerator 6-8MV photo-irradiation. Theradiotherapy treatment was given in fractions, 5 times

    per week with 2 Gy per fraction, for 7 weeks, with atotal of 70 Gy radiotherapy dosages.

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    Operational Definition Stomatitis is the inflammation of the mucous

    membrane of the mouth.

    Nausea is the inclination to vomit.Vomiting is when matter is ejected out from stomach

    through mouth.

    Dysphagia is difficulty in swallowing.

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    Operational DefinitionA weight loss more than 10%, which is Grade II weight

    loss according to National Cancer Institute, CommonToxicity Criteria, is considered as significant weightloss.

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    Research Subject Criteria for the sample to be included in the study:

    NPC stage III and IV patients who are in between ages 18to 70 years old, in which distant metastasis was notdetected

    NPC patient that received concurrent

    chemoradiotherapy in Tulip Integrated Cancer Clinic

    Required data is available in the medical record of thepatient

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    Research Method Data for weight collected before the cancer treatment,

    and after the treatment.

    Medical record is used to gain the requiredretrospective data regarding the NPC patients

    Age, gender, stomatitis, nausea, vomiting, dysphagia

    from year 2006 to 2010

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    Statistical Analysis Data collected using Microsoft Excel 2010

    Analysis using Stata

    Two sets of nominal data is analyzed using:

    Contingency Table

    Pearson Chi-Square test

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    Study Results Table 1: Patient characteristics

    Variables n %Sex Male

    Female34

    2063.0

    37.0Age 18-30

    31-40

    41-50

    51-60

    61-70

    4

    13

    21

    12

    4

    7.4

    24.1

    38.9

    22.2

    7.4

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    Study Results In the 54 subjects involved:-

    26 (48.1%) had stomatitis

    25 (46.3%) had nausea

    16 (29.6%) had vomiting

    39 (72.2%) had dysphagia

    31 patients (57.4%) had Grade II weight loss

    23 patients((42.6%) had < Grade II weight loss

    p < 0.05 is regarded as statistically significant

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    Study Results

    Age Grade II Weight Loss < Grade II Weight Loss Total

    18-30 3 1 4

    31-40 7 6 13

    41-50 15 6 21

    51-60 5 7 12

    61-70 1 3 4

    Total 31 23 54

    Chi-square, Pr = 0.268

    Table for age and weight loss

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    Table for gender and weight lossStudy Results

    Gender Grade II Weight Loss < Grade II Weight Loss Total

    Male 19 15 34

    Female 12 8 20

    Total 31 23 54

    Chi-square, Pr = 0.768Relative Prevalence = 0.931

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    Study Results Table for stomatitis, nausea, vomiting and dysphagia

    Variable n Grade II Weight Loss P-value* Relative Prevalence

    Stomatitis 26 13 (50.0%) 0.289 0.778

    Nausea 25 16 (64.0%) 0.363 1.237

    Vomiting 16 11 (68.8%) 0.274 1.306

    Dysphagia 39 25 (64.0%) 0.109 1.603

    * - from Chi-Square calculation

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    Table for risk factors (stomatitis, nausea, vomiting and dysphagia)Study Results

    Variable Grade II Weight Loss < Grade II Weight Loss Total

    With risk factor(s) 30 19 49

    Without any risk factor 1 4 5

    Total 31 23 54

    Chi-square, Pr = 0.076Relative Prevalence = 3.061

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    Study Results

    Variable Grade II Weight Loss < Grade II Weight Loss Total

    With 2 or more risk

    factors 23 12 35

    Without any risk

    factor 1 4 5

    Total 24 16 40

    Table for 2 or more risk factors (stomatitis, nausea, vomiting anddysphagia)

    From Chi-square, Pr = 0.051Relative Prevalence = 3.288

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    Discussion The study results did not support the hypothesis

    The data did not prove significant association between therisk factors and weight loss

    However, there is a trend that weight loss might be causedby the increase of more risk factors

    Results maybe more significant if more subjects is involvedin the study; minimal sample size not achieved.

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    DiscussionA weight loss of as little as 5% of body weight can

    cause reduced response to treatment (Andreyev et al,1998).

    In addition, weight loss is associated with poor qualityof life and reduced survival (Davidson et al, 2004).

    Therefore, risk factors in these patients that may causeweight loss must be well-managed.

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    Result of other Studies Demizu et al, 2006; studying efficacy and feasibility of

    cisplatin-based concurrent chemoradiotherapy fornasopharyngeal carcinoma

    Clinically significant:

    mucositis ( grade 2, 88%)

    dysphagia ( grade 2, 88%) nausea/vomiting ( grade 2, 63%).

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    Result of other Studies Lin et al, 2003; 284 patient study of concurrent

    chemoradiotherapy versus radiotherapy alone for advancednasopharyngeal carcinoma

    Weight loss Grade I II : 90.8% Grade III IV : 3.5%

    Mucositis

    Grade I II : 53.2% Grade III IV : 45.4%

    Vomiting Grade I II : 49.6%

    Grade III IV : 4.3%

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    Result of other StudiesWeight loss has always been seen as one of the non-

    hematological toxicity in treatment of cancer, and hasnot been analyzed with other risk factors

    There was no previous study that focuses on weightloss and relate it directly to other risk factors

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    Conclusion Risk factors of age, gender, stomatitis, nausea,

    vomiting and dysphagia did not show significantassociation with weight loss in NPC patients

    undergoing concurrent chemotherapy.

    However, there is a trend that weight loss might becaused by increasing combination of more risk factors

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    Limitations The lack of subjects in this study due to temporary

    dysfunction of radiotherapy equipment since June,causing decrease of expected CCRT patients.

    Some required data was not available in certainmedical record, thus lessening the subject count

    Weakness of retrospective research

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    Suggestions This research can be improved by investigating more

    risk factors, e.g. loss of appetite,

    The grade of the risk factors involved should also bespecified.

    Prospective design In the future, questionnaires can be used to help doctors

    in follow-up patients condition

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    Thank you !