Predicting responses to chemotherapy from nutrition in triple negative breast cancer patients (The PRE-NUTRITIVE Study): protocol for a prospective feasibility study

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Abstract Background Adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) cancer prevention guidelines is linked to lower cancer incidence and improved outcomes. However, the relationship between these guidelines and chemotherapy response, particularly in Triple Negative Breast Cancer, is not well understood. TNBC has the poorest survival rates among breast cancer subtypes, with only 32% of patients achieving pathological complete response after neoadjuvant chemotherapy. Predicting which patients will respond and gain survival benefits remains a challenge and identifying patients unlikely to respond would help provide more effective treatment options and reduce side-effects and hospital admissions. This study assesses the feasibility of collecting data for a clinical trial aimed at identifying factors that predict chemoresponse with particular attention on diet, nutrition, physical activity, adherence to WCRF/AICR recommendations, and tumour and circulating biomarkers. Methods This prospective, non-randomised feasibility study will recruit, over 24 months, between 15-20 triple negative breast cancer patients undergoing neoadjuvant chemotherapy. The data collected are: body mass index, chemotherapy details, surgery type, gene expression analysis in diagnostic tumour cores, serum and plasma samples for lipid and vitamin analysis, tumour response by magnetic resonance imaging during and after treatment and pathological response after treatment. Participants will complete patient-reported outcome measures, food and physical activity questionnaires, at the start and end of treatment. Discussion This study aims to explore the impact of dietary patterns on chemotherapy responses in TNBC patients, a subtype with poor prognosis and high relapse risk. Adherence to the WCRF/AICR cancer prevention guidelines is linked to reduced cancer incidence and better outcomes. However, the role of diet in predicting chemotherapy response remains unclear. The study seeks to gather data for a future clinical trial examining these connections, aligning with research priorities to prevent cancer relapse and provide evidence-based dietary advice. This feasibility study will inform patient recruitment, data collection, and trial design. Trial registration This trial was prospectively registered on 12 th December 2022 ( ISRCTN20130557 ).

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