Breast Feeding Support

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive (ER+) breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI scans. The study focuses on comparing these two diagnostic tracers' accuracy in detecting cancer lesions in ER+ breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.

Researchers are evaluating a new approach to eliminate minimal residual disease (MRD) in patients with triple negative breast cancer (TNBC) that remains after multiple treatments. This aggressive cancer type often leads to lethal metastatic disease within 2 years, especially in patients without a complete tumor response after initial chemotherapy. The study aims to improve survival and cure rates by addressing residual cancer cells despite surgery and chemotherapy. The study has two phases. Phase I involves patients with metastatic TNBC or hormone-resistant, HER2/neu-negative breast cancer receiving escalating doses of sarilumab combined with capecitabine chemotherapy. Sarilumab is given subcutaneously every 3 weeks alongside capecitabine taken twice daily for 14 days in 21-day cycles. Phase II includes patients with stage I to III TNBC with residual disease after neoadjuvant therapy, treated with a combination of sarilumab and capecitabine compared to historical controls receiving capecitabine alone. A parallel baseline arm receives standard capecitabine alone. Blood samples and optional bone marrow samples are collected during treatment. Participants will be monitored through blood tests and other evaluations during treatment cycles lasting up to 14 weeks. Researchers will assess the maximum tolerated dose and dose-limiting toxicities in Phase I and measure changes in circulating and disseminated tumor cells in Phase II. The study does not include masking or randomization. Participants must meet specific health and organ function criteria and agree to contraception requirements if applicable. The total study duration varies by participant, with safety and response closely observed throughout.

Researchers are conducting a longitudinal observational study involving 120 lactating mothers and their newborns to analyze the composition of human milk over different stages of lactation. The study aims to explore variations in milk composition across different milk groups and relate these findings to maternal, perinatal, infant factors, and the infant's microbiota. This research is sponsored by Nutricia Research and spans up to two years of follow-up. Participants will be observed without any intervention, with human milk and fecal samples collected at specific time points: Day 3 and Weeks 1.5, 4, 10, 26, 52, and 104 postpartum. The study focuses on exploratory outcome parameters related to human milk and fecal composition. Mothers will provide residual milk samples during these intervals, which will be analyzed to understand milk complexity. During the study, participants will provide milk and fecal samples at scheduled postpartum visits. Researchers will assess milk composition and infant microbiota through these samples and evaluate the relation to various maternal and infant characteristics. Mothers will need to have access to a freezer at -18°C and use a mobile device for data collection. The total participation duration can be up to two years, allowing detailed monitoring of milk and infant development.

Researchers are examining why people have different risks and outcomes for breast cancer and related breast diseases. This observational study focuses on a diverse population in South Florida, aiming to better understand both genomic and non-genomic factors that affect breast cancer risk and outcomes. The study is led by Memorial Sloan Kettering Cancer Center and includes men and women aged 18 years and older who visit breast radiology clinics for biopsy or as new breast patients. Participants will undergo blood collection at the start and during surgery when applicable, as well as tissue collection during surgery if possible. They will also complete surveys at baseline, after surgery, and at 1, 3, and 5 years of follow-up. The study involves participants with BIRADS scores from 0 to 5 and follows their clinical characteristics over up to five years. Throughout the study, participants will provide clinical information through surveys and biological samples to help researchers track their health outcomes. The main outcome measured is the clinical characteristics of participants obtained via surveys over five years. The study provides long-term monitoring of participants' breast health, with no intervention treatments involved, and aims to collect comprehensive data to understand breast cancer risks better.

Researchers are studying the effects of local treatment on health and daily life in people with early-stage breast cancer in China. The focus is on those with stage I to III invasive breast cancer receiving surgery and other therapies before or after surgery. The study aims to understand both short- and long-term physical, emotional, and social effects of treatment, including tiredness, sleep problems, emotional distress, pain, and changes in heart or lung function, to improve recovery and quality of life. Participants will receive local therapy with curative intent, which may include surgery, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given before or after surgery. This observational study involves no experimental treatment. At the start, participants undergo clinical assessments, including heart and lung tests, lab work, and collection of blood and tissue samples. They also complete questionnaires about symptoms and well-being at multiple time points over five years. During the study, participants will complete surveys about their physical symptoms, emotional health, and quality of life at baseline, one week, one month, three months, six months, one year, and then annually up to five years. Researchers will monitor treatment-related toxicities and quality of life changes through these patient-reported outcomes. The study uses electronic data collection with quality checks to ensure accurate and consistent information for analysis and future research.

This research aims to evaluate how combining Mulligan mobilization with core strengthening exercises affects postpartum females experiencing sacroiliac joint dysfunction (SIJD). SIJD is common after childbirth due to hormonal and biomechanical changes that cause pelvic instability and pain. The study explores whether adding Mulligan mobilization, a manual therapy to correct joint alignment and movement, to core strengthening can better reduce pain and improve joint function and quality of life compared to core exercises alone. Participants will receive one of two interventions: the experimental group will undergo Mulligan Mobilization with Movement (MWM) alongside core strengthening exercises, while the control group will perform core strengthening exercises alone. Mulligan MWM involves therapist-applied glides to the sacroiliac joint combined with specific movements to restore joint mechanics. Core exercises focus on strengthening muscles supporting pelvic stability, progressing over four weeks from gentle activation to functional movements. Treatments include techniques such as SIJ belt-assisted mobilization, pelvic floor engagement, and exercises like bridges, planks, and squats. During the study, women will be assessed at the start and after four weeks for pain intensity, sacroiliac joint disability, and lumbar range of motion. Researchers will monitor progress through physical tests and questionnaires to evaluate pain relief, joint function, and mobility improvements. The study will involve postpartum females aged 20 to 40 years, with participation lasting at least four weeks, and aims to support safe recovery and daily function restoration through targeted therapy.

Researchers are evaluating whether extended admission to the Kangaroo Mother Care (KMC) ward can help prevent postpartum depression (PPD) in mothers of low birthweight preterm infants in low-resource settings. This randomized controlled trial compares longer KMC ward stays to the standard care of shorter stays to examine effects on maternal depression, infant neurodevelopment, paternal depression, barriers to KMC practice, and cost effectiveness. The study includes mothers, infants, fathers, and family members to understand these outcomes comprehensively. The study involves two groups: one group of mother-infant pairs admitted to the KMC ward for more than 2 days after discharge from the neonatal intensive care unit (NICU), and the other group admitted for less than 2 days. Both groups receive support for kangaroo mother care, breastfeeding, and preterm infant care during their respective ward stays before going home. The trial enrolls mothers with infants weighing between 1000-2000 grams who have been stable in the NICU for more than 48 hours. Participants will be assessed at discharge and during follow-up visits at 2 weeks, 6-8 weeks, and at 6, 12, and 18 months. Mothers and fathers will be screened for depression, and infants will undergo neurodevelopmental screenings. Researchers will also collect information on social support, breastfeeding duration, KMC barriers, infant growth, mortality, morbidity, and healthcare costs throughout the study. The trial aims to provide detailed insights into the benefits and challenges of extended KMC in this population over an 18-month period.

Researchers are studying human milk as a complex system to understand how it changes over time and throughout the day, how these changes relate to infant sleep and microbiome patterns, and how feeding method (direct breastfeeding versus expressed milk) affects these relationships. This observational study aims to fill important knowledge gaps to better support families feeding pumped breast milk and improve infant feeding and health outcomes. The study compares two groups of mothers and infants: those primarily feeding directly at-the-breast and those primarily feeding expressed human milk. Researchers will collect data over time to model milk dynamics and their links to infant sleep and microbiome. The study focuses on lactating mothers aged 20 to 40 with healthy, full-term singleton infants aged 0 to 1 month at enrollment. Participants will be followed to assess infant sleep latency at baseline, 2 months, and 4 months. The study includes collecting information on feeding patterns, infant sleep, and microbiome dynamics. This will help understand how milk and infant factors interact over time. The total participation duration varies, with ongoing monitoring to capture these dynamic relationships in infant nutrition.

Researchers are evaluating whether eating avocados by breastfeeding mothers can provide important nutrients in human milk that support brain development in their infants. This interventional study involves healthy lactating women around 13 weeks postpartum and their infants. The goal is to see if mothers will consume five avocados a week for 12 weeks and to measure the presence of choline, lutein, and fatty acids in their milk. The study also aims to assess cognitive benefits in infants whose mothers eat avocados compared to those who do not. Mothers will be randomly assigned to either an avocado group, where they consume one avocado daily for 12 weeks, or a comparison group with no avocado intervention. Participants will visit the lab three times over six months: at enrollment (around 3 months postpartum), 4.5 months, and 6 months. Milk samples will be collected biweekly and picked up from participants, with the avocado group receiving new avocados at each pickup. Mothers will also provide diet information during these visits. Infants will undergo cognitive tests including a recognition memory test at 6 months and the Bayley Scales of Infant Development at 4.5 months. Mothers will complete temperament questionnaires at 3 and 6 months. Saliva samples will be collected, and researchers will monitor changes in choline, lutein, and fatty acid levels in milk. The study will track adherence to avocado consumption and measure infant cognitive development over the six-month period.