Search

Background: A dysbiotic vaginal microbiome (VMB) is associated with clinical conditions such as bacterial vaginosis (BV) and an increased risk of human immunodeficiency virus (HIV-1) infection. Considering the high prevalence of BV among African, Caribbean and Black (ACB) women, we conducted a prospective, randomized, open-label phase 1 clinical trial to determine the feasibility, safety and tolerability of administering low-dose estrogen, probiotics or both in combination to improve vaginal health and decrease HIV-1 susceptibility., Methods: ACB women aged 18-49 from the Greater Toronto Area (GTA) were randomized to one of four study arms: intravaginal estradiol (Estring©; 7.5mg/day); a vaginal probiotic (RepHresh™ Pro-B™) administered twice daily; a combination of Estring© and vaginal RepHresh™ Pro-B™ (twice daily); or the Estring© and oral RepHresh™ Pro-B™ (twice daily), for a duration of 30 days. Feasibility was evaluated through enrolment, retention, and adherence rates, while safety and tolerability were determined by a pre- and post-treatment blood panel and reported adverse events (AEs)., Results: Overall, 63 ACB women were screened, 50 were enrolled and received the intervention while 41 completed the study, resulting in 80% enrollment and 82% retention rates. Overall adherence to the study protocol was high at 93%, with an adherence of 92% for RepHresh™ Pro-B™ and 97% for Estring©. A total of 88 AEs were reported by 29 participants which were mild (66/88; 75%) and largely resolved (82/88;93%) by the end of the study, with no serious AEs (SAEs) noted. In addition, a panel of safety blood markers measured pre- and post-intervention confirmed no clinically significant changes in blood chemistry or blood cell count., Conclusion: Overall, the administration of intravaginal estrogen and/or probiotics in pre-menopausal ACB women is feasible, safe, and well tolerated., Trial Registration: The trial was registered with Clinicaltrials.gov (NCT03837015) and CIHR HIV Clinical Trials (CTN308)., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: GR developed the probiotic strains GR-1 and RC-14 but has had no financial interest in them for 15 years. GR consults for Seed, a company producing probiotic strains not used in this study. He was not paid salary for any roles with the company. All the other authors have declared no conflict of interest. This does not alter our adherence to PLOS One policies on sharing materials and data.”, (Copyright: © 2025 Gill et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background/objectives: This study describes the sequelae, side effects, and toxicities experienced by Canadian breast cancer survivors at a breast cancer survivorship clinic at a tertiary academic cancer centre and identifies potential risk factors which may be associated with increased side effect burden., Methods: A retrospective chart review was performed of adult patients treated at the Sunnybrook Breast Cancer Survivorship Clinic from 6 July 2022, to 30 September 2023 ( n = 435)., Results: Most patients (72.6%) reported at least one side effect impacting their quality of life, and a smaller majority (55.4%) reported two or more side effects. The most common symptoms experienced were anxiety (29.4%), chronic pain (23.9%), hot flashes (21.4%), and fear of recurrence (19.8%). Older age was strongly correlated with a lower likelihood of experiencing greater side effect burden ( p < 0.01). Patients who underwent chemotherapy were significantly more likely to experience higher side effect burden than patients who did not. Current smokers were more likely than nonsmokers or past smokers to have a higher burden, for both physical ( p < 0.01) and psychological side effects ( p < 0.01). The multivariate analysis demonstrated that younger age was strongly associated with greater side effect burden, higher likelihood of psychological and physical symptoms, and greater likelihood of requiring close follow-up., Conclusions: The results highlight the need for survivorship resources tailored to survivors under the age of 55 and the importance of referring smokers to smoking cessation programs. Additional research is required to explore the significant reluctance among patients regarding discharge. Future studies should examine the acute needs of younger breast cancer survivors and investigate the impact of smoking and treatment modalities on the side effect burden.