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TPS12149 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse effect affecting quality of life of patients of cancer undergoing chemotherapy. Carboplatin alone or in combination with various other chemotherapy drugs is one of the most commonly used drug in solid malignancies. It is categorised as a highly emetogenic drug in doses above AUC≥4 and multiple past studies revealed high CINV incidence. Current international antiemetic guidelines suggest NK1 receptor antagonist based triplet drugs as an effective regimen of CINV control in these patients. However, the nausea control rates are largely inadequate. Olanzapine, an atypical antipsychotic drug, is another drug that has shown significant activity in CINV control and is an integral part of current chemotherapy induced emesis and nausea prevention. However, robust comparative studies of olanzapine based triplets with NK1 based combination have been lacking. Hence we planned this study to compare efficacy of olanzapine containing triplet with NK1 receptor antagonist (fosaprepitant) based triplet drug combination in a phase 3 randomised study. Methods: This study is an investigator initiated phase 3 prospective randomised double blind placebo controlled trial comparing efficacy of olanzapine, 5HT3 receptor antagonist(ondansetron) and dexamethasone (experimental arm) against fosaprepitant, 5HT3 receptor antagonist(ondansetron) and dexamethasone (standard arm) for prevention of CINV among chemo-naïve patients (aged ≥18 years) receiving carboplatin (AUC ≥4) based chemotherapy regimen. Primary objective is to compare the number of patients with no nausea during overall periods (0-120 hours post-chemotherapy). Secondary objectives are to compare complete response (no emetic episodes and no use of rescue medication) in the acute(0-24 hr), delayed(25-120 hr),overall periods(0-120 hr) and to assess the frequency of rescue medication use. The other secondary objective includes assessment of adverse events in both the arms. Statistical Design: Planned accrual is total 214 patients including 10% drop out rate. It is a superiority design with an absolute improvement of 20% in the proportion of patients with no nausea from a baseline prevalence of 40% in the standard arm and two sided alpha of 5% as well as power of 80%. Conduct to date :Study activation : March 2021. Enrolment : 138 subjects. Clinical trial information: CTRI/2021/03/032165.

Additional file 1: Supplemental Table 1. Histology stratified logistic regression to predict the likelihood of treatment (A: Chemotherapy, B: Radiotherapy, C: Surgery). Supplemental Table 2. Age stratified logistic regression analysis to predict the likelihood of treatment (A: Chemotherapy, B: Radiotherapy, C: Surgery).

e24081 Background: Assessment of physical and psychological symptoms using patient-reported outcome (PRO) scales is an often overlooked aspect in oncological practice in resource constrained settings. We assessed the pattern of symptoms at diagnosis in solid organ cancers using an innovative smart device based delivery of the Edmonton Symptom Assessment Scale (ESAS). Methods: We assessed PROs using ESAS at diagnosis in adult patients diagnosed with solid organ cancers at a large tertiary care centre in New Delhi, India from September 2021 to January 2022. The ESAS was delivered to patient's smart phone as a text message that provided a unique link to complete the questionnaire in Hindi or English, as preferred by the patient. Symptom severity was categorized into physical, psychological, and total symptom domains and the scores were further classified as none to mild (0-3) or moderate to severe (4-10). Univariate and Multivariate logistic regression analyses were performed to determine predictive factors. Results: Text message with ESAS completion link was sent to 653 consecutive patients, of whom 509 (77.9%) completed the questionnaire during the study period. The median age was 52 years and 53.2 % were males. The primary cancer site was lung, breast, gastrointestinal, and others in 27.7%, 28.1%, 14.4%, and 29.8%, respectively. Pain (59.1%) and tiredness (57.8%) constituted the maximum physical symptom scores in moderate and severe category. Patients with lung cancer had most physical symptoms categorised in moderate and severe compared with other cancers (P = 0.03), while psychological symptoms were more likely to be moderate to severe females (P = 0.01). In the multivariable logistic regression analysis after adjusting for measured confounders, primary cancer site (lung vs others) and sex (female vs male) were significant predictors for moderate and severe physical and psychological symptoms, respectively. Conclusions: A simple mobile-based ESAS delivery system can help in collecting PRO data to assess symptom burden in patients diagnosed with cancer. The symptom burden assessment can aid in providing personalised symptom-directed measures to improve the quality of life of patients with cancer.