Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study
Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity. Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery. The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment). To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients. The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
NCT06025604 — Breast Cancer Female
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT06025604/
Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer. The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.
NCT06023576 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06023576/
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)
This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection. In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut. The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.
NCT06020573 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06020573/
The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital
The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are: - Does cryotherapy reduce the incidence of CIPN? - Does cryotherapy reduce the severity of CIPN and improve the quality of life? Participants will be put on the cold gloves and boots during chemotherapy injection process and total 90 minutes. If there is a comparison group: Researchers will compare usual care group to make sure if it effects of CIPN.
NCT06020222 — Chemotherapy-induced Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT06020222/
Early Point-of-Service SBDOH Screening in Breast Cancer
The overarching goal of this project is to optimize the collection of social and behavioral determinants of health (SBDOH) for patients with a pathological diagnosis of breast cancer at Penn Medicine. The investigators will measure rates of SBDOH data collection by modality and rates of referral to and uptake of social support services, time to evaluation, staff time, acceptability, patient-centered communication, medical mistrust, and clinician acceptability.
NCT06019988 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06019988/
Evaluation of the Concept "Can Do" Versus "Do Do" in Patients With Breast Cancer
Breast cancer occurs as a result of uncontrolled proliferation of cells in the breast tissue. Breast cancer is the most common type of cancer among women worldwide and is an important problem that threatens women's lives. The incidence rate has reached approximately 16 Breast cancer treatment consists of local and systemic therapies. While local treatments include surgery and radiotherapy, systemic treatments, which are administered in two different ways, namely adjuvant and neoadjuvant systemic treatments, consist of chemotherapy, hormone therapy and targeted biological therapies. Although the treatment options for breast cancer are increasing day by day, there are many complications during and after treatment. These complications negatively affect functionality and quality of life The 6-minute walk test (6MWD) is a widely used test for indirect measurement of cardiorespiratory fitness in various cancer populations. Studies have proven that the 6MWT is safe and feasible in breast cancer patients. The concept of 'can do, do do' has recently emerged to describe impaired physical functions in chronic obstructive pulmonary disease (COPD) and asthma. This concept categorizes participants into four quadrants based on physical activity level and functional capacity measurements and cut-off point. This concept has proven useful for measuring physical function in both asthma and COPD. This concept may be useful in understanding physical functioning in breast cancer patients. Therefore, The aim of this study is to apply the concept of 'can do, do do' in breast cancer patients, to determine the quadrants according to physical activity level and functional capacity measurements in breast cancer patients, to investigate whether and to what extent there is a difference, whether and to what extent there is a difference between demographic information, disease stages, comorbidity level, clinical features, peripheral muscle strength, fatigue and quality of life and upper extremity functionality according to quadrants.
NCT06018051 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06018051/
A Comparison of Upper Extremity Exercise Capacity, Maximum Oxygen Consumption, Daily Activities, and Physical Activity Level in Breast Cancer and Healthy Individuals
Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Survival can be increased with early diagnosis and more effective treatment methods. However, a wide range of treatment-related complications are observed during and/or after breast cancer treatment. Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal components. Oxygen consumption in cancer patients may be adversely affected by aging, deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
NCT06018038 — Healthy
Status: Not yet recruiting
http://inclinicaltrials.com/healthy/NCT06018038/
Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning
The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. The main questions it aims to answer are: - Evaluate the sensitivity and specificity of the early detection model for breast cancer screening - Evaluate participants' TeFei™ score Participants will be collected peripheral venous blood before surgery or systemic treatment. The blood will then be sent to the collaboration company for sequencing. The collaboration company will analyze the sequencing results and build a cfDNA multi-omics signature library. Finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. Researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.
NCT06016790 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06016790/
A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
NCT06016738 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06016738/
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+ metastatic breast cancer and LMD
NCT06016387 — HER2-positive Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT06016387/