DIANA trial tests lifestyle intervention during breast cancer chemotherapy to improve treatment response

Protocol for the randomized clinical trial was published 27 October 2026 and listed on PubMed and ClinicalTrials.gov.

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The protocol for the DIANA randomized clinical trial has been published in PLoS One, with records posted to PubMed and ClinicalTrials.gov as of 27 October 2026.^[1] The trial will test a multimodal lifestyle intervention administered during neoadjuvant chemotherapy for patients with early breast cancer. 216 women will be randomized 1:1 between the intervention arm and a standard of care control arm. Each arm will include 108 participants. Follow up will run for 6 months. Study authors hypothesize the intervention will produce a 20 percentage point improvement in favorable RCB response. They project a baseline rate of 40% in the control group, and target a 60% rate in the intervention arm.

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"Multimodal lifestyle intervention during neoadjuvant chemotherapy in patients with early breast cancer as a strategy to improve treatment response: Protocol of the DIANA randomized clinical trial." published in PloS one as a clinical trial (PubMed 42945273, doi 10.1371/journal.pone.0361188). Sample: 108 as stated in the abstract. Duration: 6 months. Results as the authors report them: A total of 216 women will be randomized (1:1) to control (standard of care, n = 108) or intervention (n = 108). · PubMed and ClinicalTrials.gov, read by the New studies instrument · the fact recordUnited Statesofficial source

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