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Short Communication International Journal of

Pharmacy Practice International Journal of Pharmacy Practice 2015, 23, pp. 357–360

Nausea, vomiting and quality of life of patients with cancer undergoing antineoplastic treatment: an evaluation by pharmacists Cinthia Madeira de Souzaa, Marília Berlofa Visacria, Graziele Baldan Ferraria, Bruna Taliani Tuana, Anna Paula Lourenço Costaa, Cristina Rosa Barbosab, Carmen Silvia P. Limac, Priscila Gava Mazzolaa and Patrícia Moriela Departments of aClinical Pathology and cClinical Medicine, School of Medical Sciences (FCM) and bChemotherapy Preparation Unit, Hospital of Clinics, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil

Keywords antineoplastic treatment; nausea; pharmacists; quality of life; vomiting Correspondence Professor Patrícia Moriel, Department of Clinical Pathology, School of Medical Sciences (FCM), University of Campinas (UNICAMP), Rua Tessália Vieira de Camargo, 126, Campinas, São Paulo 13083-970, Brazil. E-mail: [email protected] Received February 4, 2014 Accepted November 12, 2014 doi: 10.1111/ijpp.12169

Abstract Objective This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL) in patients with cancer receiving antineoplastic treatment. Methods Severity of chemotherapy-induced nausea and vomiting (CINV) was measured by Common Terminology Criteria for Adverse Events (CTCAE) and a numerical scale. QOL was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. Key findings Of the 50 patients studied, 60.0% reported nausea (40.0% CTCAE grade 1; 66.7% moderate intensity on numerical scale) and 30.0% reported vomiting (46.7% CTCAE grades 1 and 2, each; 66.7% moderate intensity on numerical scale). CINV did not influence overall QOL. Conclusion The frequency of CINV was high. There was no association between nausea/vomiting and overall QOL.

Introduction Cancer chemotherapy is associated with several adverse drug reactions including nausea, vomiting, stomatitis, myelosuppression and alopecia.[1] Chemotherapy-induced nausea and vomiting (CINV) represents a significant problem, and 59.7% and 36.4% of patients receiving chemotherapy experience nausea and vomiting, respectively, according to data from a multicentre study conducted in Denmark, France, Italy, Germany, UK and USA during 2001 to 2002.[2] In another study, the inability to control CINV reduced the quality of life (QOL).[3] Determination of QOL can aid in clinical decision making regarding treatment, serve as a prognostic factor for response to therapy and identifies aspects that influence patient survival.[4] The aim of this study was to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to QOL in patients with cancer receiving antineoplastic treatment. © 2015 Royal Pharmaceutical Society

Methods A cross-sectional study was conducted at a Brazilian teaching hospital from July 2012 to February 2013. The Research Ethics Committee approved the study, and all patients signed an informed consent form authorizing use of their data. The outpatients were included by convenience sampling. All patients attending the clinic for a repeat dose of chemotherapy on the period of the study were invited to take part. There were no exclusions. Just prior to chemotherapy administration, all patients received antiemetic intravenous infusion (IV) prophylaxis for acute CINV in the ambulatory. All patients received a standard prescription for treatment of delayed CINV (metoclopramide 10–20 mg orally every 6 h and dimenhydrinate 50–100 mg orally every 6 h, as required) started one day after the chemotherapy administration at home. International Journal of Pharmacy Practice 2015, 23, pp. 357–360

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Nausea, vomiting & quality of life in cancer

Additionally, oral ondansetron and/or dexametasone was prescribed based on patients’ history of CINV in previous cycles. Face-to-face structured interviews were conducted with consenting patients while they were receiving the chemotherapy infusion. Data were collected about presence or absence of CINV reported at any time after receiving the first dose of the same chemotherapy protocol that has been infused at the assessment. The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, version 4.0,[5] was completed to assess QOL. This instrument has four domains: physical, social/family, emotional and functional. Data on severity of nausea and vomiting were collected face to face using a numerical scale, based on Edmonton Symptom Assessment System,[6] and the standard National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v.4.0).[7] These instruments independently assess nausea and vomiting. The numerical scale is a rating scale from 0 to 10 (0–2 (mild), 3–6 (moderate), 7–10 (intense) ), and the patient himself selects the number associated with his severity. CTCAE assesses the severity of nausea (grades 1–3) and vomiting (grades 1–4). Grades 1 and 2 are considered mild/moderate, and grades 3 and 4 are considered severe/life-threatening. These grades are assessed by the clinical team according to patient’s report comparing them with the descriptors in CTCAE. Data on patient demography, primary cancer, chemotherapy regimen (classified by emetic risk[8]) and antiemetic IV prophylaxis CINV were collected from the patient record. Statistical analyses were performed using SPSS for windows (version 6.1.3) (SPSS Inc., Chicago, IL, USA) and SAS System for windows (version 9.3) (SAS Institute Inc,

Table 1

Cary, NC, USA). Multivariate stepwise linear and logistic regression model analyses were used to explore associations between (1) demographic data and treatment with occurrence and severity of nausea and vomiting (numerical scale and CTCAE); and (2) demographic data, treatment, occurrence and severity of nausea and vomiting (numerical scale and CTCAE) with QOL (total FACT-G score and specific domain scores). Values for severity of nausea and vomiting obtained using the two scales were compared using Spearman’s correlation. The significance level was set at 5% (P < 0.05).

Results Fifty patients were recruited. The average age was 58.1 years, and the majority were whites (90%), male (54%), with ≤6 years of education (80%) and diagnosed with a gastrointestinal neoplasm (72%). Patients were treated with moderately (44%), minimally (30%), highly (18%) and low (8%) emetogenic chemotherapies. Moreover, 70% were administered ondansetron 16 mg IV + dexamethasone 20 mg IV on day 1, 28% were given ondansetron 16 mg IV + dexamethasone 10 mg IV on day 1 and 2% received metoclopramide 10 mg IV on day 1. Following treatment, 60% (30/50) of patients reported nausea, 30% (15/50) vomiting and 38% (19/50) neither; 28% (14/50) had nausea and vomiting, 32% (16/50) had nausea only and 2% (1/50) had vomiting only. The majority of patients were assessed at CTCAE grade 1 or 2, or moderate on the numerical scale. There were no patients with grade 4 of toxicity (Table 1). There was no association between the demographic characteristics, antiemetic IV prophylaxis used

Distribution of patients according to frequency and severity of nausea and vomiting presented

No Yes

Nausea

Vomiting

Patients

Patients

n

%

n

%

20 30

40.0 60.0

35 15

70.0 30.0

Severity CTCAE Grade 1 Grade 2 Grade 3 Grade 4 Numerical scale Mild (0–2 points) Moderate (3–6 points) Intense (7–10 points)

12 11 7 —

40.0 36.7 23.3 —

7 7 1 0

46.7 46.7 6.6 0.0

6 20 4

20.0 66.7 13.3

0 10 5

0.0 66.7 33.3

CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events. © 2015 Royal Pharmaceutical Society

International Journal of Pharmacy Practice 2015, 23, pp. 357–360

Cinthia Madeira de Souza et al.

Table 2

359

Quality of life by FACT-G Mean score [standard deviation]

Nausea Without nausea Grade 1 Grade 2 Grade 3 Mild (0–2 points) Moderate (3–6 points) Intense (7–10 points) Vomiting Without vomiting Grade 1 Grade 2 Grade 3 Mild (0–2 points) Moderate (3–6 points) Intense (7–10 points) Without nausea and vomiting With nausea and vomiting All patients (total)

Physical well-being

Social/family well-being

Emotional well-being

Functional well-being

Total FACT-G

16.2 [4.1] 16.2 [4.0] 16.1 [4.2] 16.4 [4.2] 16.2 [4.1] 16.3 [4.1] 16.4 [4.2]

20.2 [2.7] 20.4 [2.8] 20.6 [2.6] 20.3 [2.8] 20.2 [2.7] 20.2 [2.8] 20.3 [2.8]

16.1 [3.2] 16.4 [3.2] 16.3 [3.2] 16.2 [3.3] 16.1 [3.2] 16.3 [3.2] 16.2 [3.3]

17.5 [2.7] 17.3 [2.7] 17.4 [2.5] 17.6 [2.7] 17.5 [2.7] 17.4 [2.7] 17.6 [2.7]

70.0 [5.9] 70.3 [5.6] 70.4 [6.0] 70.5 [6.4] 70.0 [5.9] 70.2 [5.9] 70.5 [6.4]

16.2 [4.1] 16.1 [4.0] 16.4 [4.2] 18 16.2 [4.1] 16.4 [4.2] 17.0 [3.9] 16.2 [4.1] 16.4 [4.2] 16.4 [4.2]

20.2 [2.7] 20.7 [2.7] 20.3 [2.8] 18 20.2 [2.7] 20.3 [2.8] 19.7 [2.0] 20.2 [2.7] 20.3 [2.8] 20.3 [2.8]

16.1 [3.2] 16.1 [3.2] 16.2 [3.3] 12 16.1 [3.2] 16.2 [3.3] 16.5 [3.2] 16.1 [3.2] 16.2 [3.3] 16.2 [3.2]

17.5 [2.7] 17.2 [2.4] 17.6 [2.7] 19 17.5 [2.7] 17.6 [2.7] 17.6 [2.7] 17.5 [2.7] 17.6 [2.7] 17.5 [2.7]

70.0 [5.9] 70.1 [5.9] 70.5 [6.3] 67 70.0 [5.9] 70.5 [6.4] 70.9 [6.2] 70.0 [5.9] 70.5 [6.4] 70.4 [6.4]

Total FACT-G, overall quality of life.

and chemotherapy emetic risk score with occurrence or severity of nausea and vomiting. The only significant association was between female gender and higher degree of nausea by CTCAE (multivariate linear regression, P = 0.0383). There was a significant correlation between severity of nausea and severity of vomiting, independent from the evaluation instrument (Spearman’s correlation coefficients (P < 0.05): nausea numerical scale × vomiting numerical scale = 0.598; nausea CTCAE × vomiting CTCAE = 0.574; nausea numerical scale × vomiting CTCAE = 0.606; nausea CTCAE × vomiting numerical scale = 0.563). Moreover, there was a strong correlation between the two instruments for nausea (Spearman’s correlation coefficients (P < 0.05): numerical scale × CTCAE = 0.962) and for vomiting (Spearman’s correlation coefficients (P < 0.05): numerical scale × CTCAE = 0.991). QOL in patients undergoing chemotherapy is shown in Table 2. The domain of social and family scored most highly. The only factor found to be significantly associated with either the overall QOL score, or individual domains, was absence of vomiting with higher scores in the emotional wellbeing domain (multivariate linear regression, P = 0.0153).

Discussion Results from this study indicate that (1) few patients experienced severe nausea and vomiting post chemotherapy; (2) there was strong correlation between the CTCAE and numerical scale; (3) women were most likely to suffer worse © 2015 Royal Pharmaceutical Society

nausea; and (4) there was no association between nausea/ vomiting and overall QOL. This study is the first showing that QOL is not associated with CINV. It is limited due to the small patient cohort, its cross-sectional design, lack of sample size calculation and single-centre location. The assessment of QOL was done using a validated instrument for cancer patients, but debility and communication problems may make it difficult for patients to respond to all questions, and as in the present study some responses were mediated by a healthcare professional. Similarly, patients had difficulty self-assessing intensity of CINV on a numerical scale and antiemetic agents administered for control of delayed CINV. International protocols classify chemotherapies into four risk categories based on percentage of patients experiencing emesis in the absence of prophylaxis (high: > 90%; moderate: 30 − 90%; low: 10 − 30%; minimal: < 10%).[8] In addition, some patient-related factors have previously been shown to be associated with an increased risk of CINV.[9,10] However, except for gender, this study failed to observe any association between patient or treatment characteristics and CINV. The results obtained from the QOL analysis showed the importance of good social and family support during oncological treatment. Interestingly, although the domain of physical well-being had one of the lowest individual domain scores, this was not associated with having or not having CINV. This may be because of those reporting CINV, the severity was only reported to mild to moderate, due to a good prophylaxis regimen. Before this study, we considered CTCAE a more International Journal of Pharmacy Practice 2015, 23, pp. 357–360

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robust method for severity assessment, but as the study showed excellent correlation between numerical scale and CTCAE instrument and given that numerical scale is easier and more practical for team evaluation, now we can also consider this a consistent instrument.

Conclusions The frequency of mild and moderate CINV was high in the studied population. Instruments for assessing severity of CINV show excellent correlation, and there was no association between nausea/vomiting and overall QOL.

Declarations Conflict of interest The authors declared no conflicts of interest with respect to the research, authorship and/or publication of this article.

Funding This work was supported by Coordination for the Improvement of Higher Level Personnel (Capes) and National Council for Scientific and Technological Development (CNPQ).

References 1. Poddar S et al. Pattern of adverse drug reactions due to cancer chemotherapy in tertiary care teaching hospital in Bangladesh. Dhaka Univ J Pharm Sci 2009; 8: 11–16. 2. Bloechl-Daum B et al. Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 2006; 24: 4472–4478. 3. Ballatori E et al. The impact of chemotherapy-induced nausea and vomiting on health-related quality of life. Support Care Cancer 2007; 15: 179– 185.

© 2015 Royal Pharmaceutical Society

Acknowledgements The authors would like thank all the pharmacists and investigators who participated in this study.

Authors’ contributions CMDS: conception and design, acquisition of data, analysis and interpretation of data, and participation in drafting the article. MBV: conception and design, analysis and interpretation of data, and participation in drafting the article. GBF: acquisition of data, analysis and interpretation of data, and participation in drafting the article. BTT: analysis and interpretation of data and participation in drafting the article. APLC: acquisition of data and analysis and interpretation of data. CRB: conception and design and acquisition of data. CSPL: participation in revising it critically for important intellectual content. PGM: participation in revising it critically for important intellectual content. PM: conception and design, analysis and interpretation of data, participation in drafting the article and final approval of the version to be published. All Authors state that they had complete access to the study data that support the publication.

4. Movsas B. Quality of life in oncology trials: a clinical guide. Semin Radiat Oncol 2003; 13: 325–347. 5. Cella D Manual of the functional assessment of chronic illness therapy (FACIT Scales) (Version 4.1). (Evanston, IL: Center on Outcomes Research and Education (CORE) Evanston Northwestern Healthcare), 2004. 6. Bruera E et al. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 1991; 7: 6–9. 7. U.S Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). U.S

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Version 4.0, 2010. 8. Roila F et al. Prevention of chemotherapy-and radiotherapyinduced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol 2006; 17: 20–28. 9. Jordan K et al. Guidelines for antiemetic treatment of chemotherapy-induced nausea and vomiting: past, present, and future recommendations. Oncologist 2007; 12: 1143–1150. 10. Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med 2008; 358: 2482–2494.

International Journal of Pharmacy Practice 2015, 23, pp. 357–360

Nausea, vomiting and quality of life of patients with cancer undergoing antineoplastic treatment: an evaluation by pharmacists.

This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL)...
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