Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success. This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.
NCT06461650 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06461650/
Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer
NCT06460298 — Triple Negative Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/triple-negative-breast-cancer/NCT06460298/
Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study
Based on the best evidence, this study intends to construct resistance appropriate for this clinical scenario,The training program was designed in a randomized controlled study for patients with breast cancer after surgery for a period of 3 months,To investigate the effect of resistance training on the grip strength of the affected limb, the range of motion of the shoulder joint of the affected limb, the occurrence of lymphedema of the affected limb, and the quality of life of patients with breast cancer after surgery,To provide theoretical guidance and practical basis for functional rehabilitation management of patients with affected limbs after surgery.
NCT06459245 — Breast Cancer Female
Status: Enrolling by invitation
http://inclinicaltrials.com/breast-cancer-female/NCT06459245/
Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
NCT06459193 — Peripheral Neuropathy Due to Chemotherapy
Status: Not yet recruiting
http://inclinicaltrials.com/peripheral-neuropathy-due-to-chemotherapy/NCT06459193/
SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
Primary objectives: - To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy. - To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life. Secondary objectives: - To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens. - Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
NCT06458764 — Breast Cancer Female
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT06458764/
:Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients With Metastatic Breast Cancer
This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients. This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.
NCT06458413 — Breast Cancer Recurrent
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-recurrent/NCT06458413/
Studying The Association Between Environmental Exposure to Polyfluoroalkyl Substances and Breast Cancer in Assiut Governorate- Egypt
1. Measuring serum level of PFAS in breast cancer female patients and healthy participants. 2. Studying the correlation between serum level of PFAS and breast cancer risk through statistical modeling and analysis. 3. Studying the magnitude of environmental exposure through measuring levels of PFAS in air and water sources of corresponding participants.
NCT06457282 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06457282/
Multiple Risk Factor Intervention Trial In Breast Cancer Survivors
This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: - What is the impact of exercise on cardiometabolic health and body composition in BC survivors? - What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition? - Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors? The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.
NCT06454864 — Breast Cancer Female
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT06454864/
NEODOXy: Targeting Cancer Stem Cells With NEOadjuvant DOXYcycline in Patients With Early Estrogen Receptor Positive / Human Epidermal Growth Factor Receptor 2- Negative Breast Cancer. A Prospective, Multicenter, Single Arm, Open Label Phase II Trial
Despite modern surgical and medical treatments, breast cancer can re-occur and lead 20% of patients to death. During the last 20 years, pre-clinical studies have shown that treatment failures may be due to the presence of a sub-type of cancer cells, the cancer stem cells, which are resistant to chemotherapy and radiotherapy. By chance, doxycycline, an old, inexpensive and safe molecule seems to target effectively these cancer stem cells. This study proposes to check for the clinical efficacy of doxycycline to target the cancer stem cells and improve the response to neoadjuvant chemotherapy in ER+/HER2- breast cancers.
NCT06452394 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06452394/
Aurora's Impact on Mitigating Adverse Effects of Neoadjuvant Chemotherapy in Breast Cancer Patients in Chile's Metropolitan Region.
Breast cancer is the most prevalent cancer worldwide and the leading cause of cancer death among women in Chile. The Aurora intervention program is designed to improve the quality of life and mitigate the physical consequences of breast cancer in patients undergoing neoadjuvant chemotherapy. It aims to promote physical activity through a human-centered design product system, incorporating elements of personal motivation, peer learning, and community engagement in alignment with the COM-B model. In a 9-week randomized controlled trial, we will include 30 female patients under 70 years undergoing neoadjuvant therapy for breast cancer in the Metropolitan Region of Chile. Baseline and post-intervention measurements will assess biopsychosocial breast cancer effects through a questionnaire as well as adverse physical effects through functional capacity tests. Biological consequences will be evaluated through lipid profiling, inflammation biomarkers, and tumor progression. In addition, Aurora's patient perception of behavior change will be addressed by analyzing the patient's records in a journal. Moreover, the perceived value of Aurora's design attributes influencing behavior change will be studied through in-depth interviews. Preliminary results describe Aurora's design process and indicate that it is well-received by patients, especially as its logbook is a valuable tool for self-reflection and progress tracking. The study anticipates the confirmation that significantly higher physical activity, improved quality of life, and enhanced functional capacity will be attained in the intervention group. The Aurora intervention program represents a novel approach to support breast cancer patients undergoing chemotherapy, emphasizing physical activity, peer learning, and self-reflection. The integration of the behavior change COM-B model and a human-centered design provides a facilitating tool for tailored interventions for breast cancer patients' needs. Yet, the potential correlation between physical activity, fatty acid metabolism, and chemotherapy response necessitates further exploration. The Aurora intervention program shows promise as a supportive tool for breast cancer patients undergoing neoadjuvant chemotherapy. Further research is imperative to evaluate the intervention's impact on patient outcomes, refine the design based on user feedback, and explore potential relationships among physical activity, fatty acid metabolism, and chemotherapy response.
NCT06449417 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06449417/