Aspirin as an adjuvant treatment for cancer:feasibility results from the Add-Aspirin randomised trial

BACKGROUND: Preclinical, epidemiological, and randomised data indicate that aspirin might prevent tumour development and metastasis, leading to reduced cancer mortality, particularly for gastro-oesophageal and colorectal cancer. Randomised trials evaluating aspirin use after primary radical therapy are ongoing. We present the pre-planned feasibility analysis of the run-in phase of the Add-Aspirin trial to address concerns about toxicity, particularly bleeding after radical treatment for gastro-oesophageal cancer.METHODS: The Add-Aspirin protocol includes four phase 3 randomised controlled trials evaluating the effect of daily aspirin on recurrence and survival after radical cancer therapy in four tumour cohorts: gastro-oesophageal, colorectal, breast, and prostate cancer. An open-label run-in phase (aspirin 100 mg daily for 8 weeks) precedes double-blind randomisation (for participants aged under 75 years, aspirin 300 mg, aspirin 100 mg, or matched placebo in a 1:1:1 ratio; for patients aged 75 years or older, aspirin 100 mg or matched placebo in a 2:1 ratio). A preplanned analysis of feasibility, including recruitment rate, adherence, and toxicity was performed. The trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN74358648) and remains open to recruitment.FINDINGS: After 2 years of recruitment (October, 2015, to October, 2017), 3494 participants were registered (115 in the gastro-oesophageal cancer cohort, 950 in the colorectal cancer cohort, 1675 in the breast cancer cohort, and 754 in the prostate cancer cohort); 2719 (85%) of 3194 participants who had finished the run-in period proceeded to randomisation, with rates consistent across tumour cohorts. End of run-in data were available for 2253 patients; 2148 (95%) of the participants took six or seven tablets per week. 11 (0·5%) of the 2253 participants reported grade 3 toxicity during the run-in period, with no upper gastrointestinal bleeding (any grade) in the gastro-oesophageal cancer cohort. The most frequent grade 1-2 toxicity overall was dyspepsia (246 [11%] of 2253 participants).INTERPRETATION: Aspirin is well-tolerated after radical cancer therapy. Toxicity has been low and there is no evidence of a difference in adherence, acceptance of randomisation, or toxicity between the different cancer cohorts. Trial recruitment continues to determine whether aspirin could offer a potential low cost and well tolerated therapy to improve cancer outcomes.FUNDING: Cancer Research UK, The National Institute for Health Research Health Technology Assessment Programme, The MRC Clinical Trials Unit at UCL.</p

Effect of a planned training session on good clinical practice knowledge in research professionals: A pilot study

Context: Adherence to good clinical practice (GCP) guidelines by the researcher provides public confidence that the rights, safety and well-being of human participants involved in research are protected. It has been observed that researchers require basic GCP training. Considering this, we had decided to conduct a training session on overview of GCP. Aims: To strengthen the knowledge and awareness regarding GCP. Settings and Design: The design of the study was quasi-experimental one group, pre-test and post-test design and the study was conducted at ACTREC among healthcare professionals at Tata Memorial Centre. Methods and Material: A semi-structured questionnaire was used to collect the data in pre and post-test. A total of 138 participants were participated in the study. The training session was pre-planned which included a lecture followed by the question-answer session. Statistical Analysis Used: Wilcoxon Signed Rank test was used to assess the effect of the planned teaching programme. Macnemar test was used for item wise comparison of pre and post-test scores. Mann Whitney test was used to determine the significant difference between knowledge scores and selected demographic variables. Results: This study has resulted in overall improvement of knowledge with a median difference of 5 with P-value <0.001. There was a statistically significant improvement of knowledge between pre and post-test of those having GCP training in the past, working group and education. Conclusions: The exercise of holding training program was found to be significant in improving the knowledge base of participants, especially investigators and study coordinators

Translation and Validation of COST - FACIT (Version 2) Questionnaire into Hindi and Marathi to Assess Financial Toxicity in Indian Cancer Patients

Abstract Amit Joshi Background Cancer is one of the most expensive and exhaustive medical conditions with a huge impact on the financial condition of the patient and their family members. A lot of advancements have led to improvement in the survival of the patients but at a raised cost. Comprehensive Score for financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST - FACIT Version 2) is one such validated and widely used tool. Assessing the financial burden in our country is still far more challenging as COST - FACIT is available in the English language but not in any regional language. Hence, we decided to validate this tool in Hindi and Marathi languages. Material and Methods A single-center, cross-sectional study was conducted in the Department of Uro-Oncology at the Tata Memorial Hospital. The original version of the COST - FACIT (Version 2) was translated from English into Hindi and Marathi languages, following the FACIT translation method and tested for content validity that included two forward translations, followed by reconciliation and a backward translation. The questionnaires were then approved by the FACIT team, and pilot testing was done for 20 patients (10 for each Hindi and Marathi language). Each of these 20 patients, after filling up the questionnaire themselves, was interviewed for any difficulty encountered during answering the questionnaire. Based on the suggestions or interpretations of this pilot testing, the necessary changes were incorporated in the final Hindi and Marathi questionnaires. Results A total of 20 patients (10 each for Hindi and Marathi) were included for pilot testing of the questionnaire. The median age of the entire cohort was 61 years (27–79). The questionnaires showed good content and face validity and demonstrated a high internal consistency (Cronbach's α: 0.85 for Hindi, 0.89 for Marathi). Conclusion The questionnaire COST - FACIT (Version 2) has been approved and validated in Hindi and Marathi languages by the FACIT team for use in clinical practice and studies