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Introduction: Treatment of pregnancy‐associated breast cancer is complex, as providers try to balance risks to the pregnant person and the developing fetus. Given increased case fatality and increasing incidence, there is a pressing need understand the efficacy and safety of different treatment regimens in this population; however, pregnant and lactating people have traditionally been excluded from participating in randomized controlled trials (RCTs). Given recent efforts to expand the inclusion criteria for oncology RCTs, this study aimed to review the inclusion/exclusion criteria of current breast cancer RCTs to assess what proportion of trials permitted enrollment of pregnant and lactating persons. Material and methods: We conducted a comprehensive search of ClinicalTrials.gov in January 2022 to identify interventional studies of breast cancer in adults that were actively recruiting. The primary outcomes were the exclusion of pregnant and lactating people. Results: The search identified 1706 studies, of which 1451 met eligibility criteria. Overall, 69.4% and 54.8% of studies excluded pregnant and lactating people, respectively. The exclusion of pregnant and lactating persons differed by study characteristics but extended across all trial designs, locations, phases and interventions. Exclusion of pregnant and lactating persons was most common in trials where the intervention was biological (86.3%), drug (83.5%) or radiation (81.5%). Conclusions: The exclusion of pregnant and lactating people from clinical trials contributes to evidence gaps in how to treat this population. A paradigm shift is needed that focuses on how research can be used to protect pregnant people from future harms, instead of protecting pregnant people from research‐related risks. [ABSTRACT FROM AUTHOR]

This study (ISRCTN17174559) aimed to explore the efficacy and safety of a kind of herbal porridge (Hou Gu Mi Xi) on the clinical symptoms of functional dyspepsia (FD). This was a single‐center, single‐dose, prospective, double‐blind, randomized controlled trial involving 64 participants with FD (35 cases and 29 controls) for 2 months of intervention and 1 month of follow‐up. The 7‐point Global Overall Symptom Scale (GOSS), 36‐Item Short Form Survey (SF‐36), and other indicators were assessed at baseline (day 0), at days 15, 30, and 60 of treatment, and at follow‐up 1 month after the end of the intervention. Many participants with FD achieved remission of their epigastric symptoms at follow‐up on the 90th day after treatment with herbal porridge compared to the placebo group (45.71% vs. 20.69%, p =.036). Furthermore, herbal porridge appeared to be effective in improving the quality of life of participants with FD, which was reflected in the rising SF‐36 scores for physical role, bodily pain, emotional role, and mental health. Although adverse events were reported, there was no overall difference in the number of adverse events between the two groups (p =.578). Herbal porridge is another effective and safe method for improving the symptoms and quality of life in patients with FD. [ABSTRACT FROM AUTHOR]