A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.
NCT05651087 — Hormone Receptor-positive Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/hormone-receptor-positive-breast-cancer/NCT05651087/
A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer
This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.
NCT05650086 — Breast Cancer
Status: Suspended
http://inclinicaltrials.com/breast-cancer/NCT05650086/
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.
NCT05649475 — Stage I-III Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/stage-i-iii-breast-cancer/NCT05649475/
The Effect of Premedication Methods to be Applied to Prevent Preoperative Anxiety in Patients Who Will be Operated for Breast Cancer, on Postoperative Anxiety and Pain
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery.
NCT05647642 — Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery
Status: Recruiting
http://inclinicaltrials.com/female-patients-under-the-age-of-65-who-will-undergo-breast-cancer-surgery/NCT05647642/
Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes
The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.
NCT05642897 — Breast Cancer Female
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT05642897/
The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy
Breast cancer is the most common malignant tumor in women worldwide and neoadjuvant therapy has been the standard care for local advanced breast cancer. Moreover, neoadjuvant therapy undoubtedly provides an ideal model to evaluate the response to therapy. Cell-in-cell structures (CICs) refer to the presence of one or more cells inside host cell, which generally leads to the death of inner cells. Notably, established evidences indicated that CICs were present in breast cancer and tend to impact patient survival. However, whether CICs profile could predict efficacy of therapy remains unclear. In this prospective cohort study, the CICs number and profile will be detected in tumor tissue before and after the neoadjuvant therapy. Then the association between CICs number including dynamic changing and response rate will be explored.
NCT05642104 — Breast Neoplasms
Status: Recruiting
http://inclinicaltrials.com/breast-neoplasms/NCT05642104/
Effects of an Exercise Intervention on Taxane-induced Peripheral Neuropathy in Breast Cancer Survivors
The purpose of this study is to examine the effects of an exercise program on the management of TIPN in breast cancer survivors. This experimental study utilizes purposive sampling to recruit 88 adults, newly diagnosed with stage I~III breast cancer women, who are expected to be treated with Taxane chemotherapy in a medical center located in central Taiwan. Participants will be randomly allocated to the experimental or observational group. The main outcomes are peripheral neuropathy and neuropathic pain. The 3~6 months home-based extremity exercise program will be intervened between newly diagnosed with breast cancer to the completion of chemotherapy. Participants have to perform a total of 50 minutes of exercise including the Ten Skilled Hand exercise fourth a day, 5 minutes each time and Buerger Allen exercise twice a day, 15 minutes each time. This study expects that the extremity exercise program will be able to prevent and manage peripheral neuropathy and neuropathic pain via increasing blood circulation. Moreover, the exercise program may also improve functioning and QOL in breast cancer survivors receiving Taxane chemotherapy.
NCT05641571 — CIPN - Chemotherapy-Induced Peripheral Neuropathy
Status: Not yet recruiting
http://inclinicaltrials.com/cipn-chemotherapy-induced-peripheral-neuropathy/NCT05641571/
Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine: A Randomized Controlled Trial.
The aim of the study is to evaluate the efficacy of using combination of Urea-based cream (CARBAMIDE®) and topical diclofenac (VOLTAREN®) Emulgel 1% for improving the incidence of Hand-foot syndrome in histologically proven breast cancer Egyptian patients receiving single agent chemotherapy Capecitabine (XELODA ®) and Its effect on improving patients' quality of life.
NCT05641246 — Hand and Foot Syndrome
Status: Completed
http://inclinicaltrials.com/hand-and-foot-syndrome/NCT05641246/
Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Single-arm, Open-label Trial
Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.
NCT05640778 — Luminal B/HER2-negative Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/luminal-b-her2-negative-breast-cancer/NCT05640778/
A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
This study will evaluate the efficacy of Losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular senescence/inflammation in the breast and the lung of irradiated breast cancer patients relative to placebo treatment and consequently improve clinical outcomes in breast cancer patients.
NCT05637216 — Radiation Induced Fibrosis
Status: Recruiting
http://inclinicaltrials.com/radiation-induced-fibrosis/NCT05637216/