Baden

Researchers are investigating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early or locally advanced estrogen receptor-positive and HER2-negative breast cancer who have no detectable circulating tumor DNA ctDNA before treatment and show endocrine responsiveness. This phase II performance study focuses on comparing these treatments effectiveness, measured by the modified preoperative endocrine prognostic index PEPI score at surgery, while also considering quality of life outcomes. Participants first provide blood and tumor samples for ctDNA assessment using the SignateraTM test. They then receive aromatase inhibitor AI therapy for 4 weeks during a Run-in phase, with a tumor biopsy after 3 weeks to evaluate Ki-67 levels. Based on ctDNA results and Ki-67 values, participants are assigned to one of three groups neoadjuvant AI or tamoxifen if AI is not tolerated for responders, or chemotherapy for non-responders. The Main Treatment Phase lasts 6 to 8 months, followed by surgery and a 5-year follow-up period. Throughout the study, participants attend multiple clinic visits for checkups, blood draws for ctDNA monitoring, and questionnaires about quality of life, symptoms, and sexual health. Key assessment points include before treatment start, after 3 weeks of AI therapy, prior to the Main Treatment Phase, mid-therapy, post-treatment, surgery, and annual follow-ups. Some participants receiving adjuvant chemotherapy have an additional visit after completing chemotherapy. The study evaluates several outcomes including PEPI score, residual cancer burden, survival measures, and breast conservation rates.

Researchers are evaluating the use of percutaneous auricular Vagus Nerve Stimulation pVNS combined with standard rehabilitation training in patients with chronic musculoskeletal or myofascial back pain. This pilot study aims to assess the feasibility, efficacy, and safety of personalized pVNS therapy using the VIVO4 wearable medical device, compared to standard care alone, during a 3-week inpatient rehabilitation period. The study builds on previous findings that pairing vagus nerve stimulation with exercise can benefit pain management in stroke and back pain patients. Participants will be randomly assigned to one of two groups the treatment group will receive personalized pVNS therapy alongside standard rehabilitation care, while the control group will receive standard care only. Personalized pVNS involves adjusting the stimulation amplitude to a comfortable tingling sensation at the ear to activate certain nerve fibers without causing pain. Participants and investigators can adjust the stimulation levels using the VIVO4 device during the rehabilitation stay. Treatment lasts for 3 weeks, with optional follow-up periods at 3 and 6 months to evaluate sustained effects. During the study, participants will undergo assessments including questionnaires on pain, disability, usability of the device, quality of life, and mental health. Researchers will monitor pain levels, functional outcomes using the Oswestry Disability Index, and socioeconomic data from baseline through treatment and follow-up. All medications and therapies used by participants will be carefully recorded. The total participation period includes the 3-week treatment and follow-up evaluations to assess lasting benefits and safety.