Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
NCT06007027 — Genitourinary Syndrome of Menopause
Status: Not yet recruiting
http://inclinicaltrials.com/genitourinary-syndrome-of-menopause/NCT06007027/
Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer.
NCT06006299 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06006299/
The Effect of Counselling and Follow-up After Breast Cancer Awareness Education on Early Diagnosis and Healthy Lifestyle Behaviours: 'Reduce Risks, Increase Life Chances'
The aim of the study was to examine the effect of counselling and follow-up after education on the risks and prevention methods of breast cancer on early diagnosis behaviours and healthy lifestyle behaviours. The population of the study will consist of female administrative staff working at Mersin University. The sample of the study will consist of 160 people. A total of 160 personnel determined by randomisation will be divided into group A (study) and group B (control) formed by the independent researcher in the computer environment. All participants will be given a one-hour training on breast cancer and will be practised with a model as well as a presentation. Group A will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received. In group B, no additional application will be made except for the training. The data of the study will be collected before and 6 months after the training by using the Descriptive Characteristics Form, Breast Cancer Early Diagnosis Behaviours Form, Counselling Form and Healthy Lifestyle Behaviours Scale II. The data obtained from the study will be analysed in a computer environment. Number, percentage, mean and standard deviation will be used as descriptive statistics in the evaluation of the data.
NCT06005025 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06005025/
Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.
NCT06003764 — Dermatitis, Radiation Induced
Status: Recruiting
http://inclinicaltrials.com/dermatitis-radiation-induced/NCT06003764/
Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients
The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN). The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs. HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow. HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body. This study will mainly measure: - duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.
NCT06003114 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT06003114/
The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: - Abemaciclib (CDK4 and CDK6 inhibitor) - Tamoxifen (Selective estrogen receptor modulator) - Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) - Exemestane (steroidal aromatase inhibitor) - LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
NCT06001762 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06001762/
Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer
Breast cancer is a malignant tumor with the highest morbidity and mortality among women worldwide. Accurate staging of axillary lymph nodes is critical for metastatic assessment and decisions regarding treatment modalities in breast cancer patient. Among patients who underwent sentinel lymph node biopsy, about 70 % of the patients had negative pathological results and in other words, these 70 % of the patients received unnecessary surgery. At present, imaging and pathological diagnosis is the main measure of lymph node metastasis in breast cancer. However, limitations remained. Artificial intelligence, including deep learning and machine learning algorithms, has emerged as a possible technique, which can make a more accuracy prediction through machine-based collection, learning and processing of previous information, especially in radiology and pathology-based diagnosis. With the intensification of the concept of precision medicine and the development of non-invasive technology, the investigators intend to use the artificial intelligence technology to develop a serum and tissue-based predictive model for sentinel lymph node metastasis diagnosis combined with imaging and pathological information, providing specific, efficient and non-invasive biological indicators for the monitoring and early intervention of lymph node metastasis in patient with breast cancer. Therefore, the investigators retrospectively include serum samples from early breast cancer patients undergoing sentinel lymph node biopsy, including a discovery cohort and a modeling cohort. Metabolites were detected and screened in the discovery cohort and then as the target metabolites for targeted detection in the modeling cohort. Combined with preoperative imaging and pathological information, a prediction model of breast cancer sentinel lymph node metastasis based on serum metabolites would be established. Subsequently, multi-center breast cancer patients will prospectively be included to verify the accuracy and stability of the model.
NCT06001528 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06001528/
A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer
This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.
NCT06000917 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06000917/
The Effect of Tele-Nursing Practices Based on Technological Competence Theory on Empowerment and Symptom Management in Breast Cancer Patients
This research is a randomized controlled double-blind experimental study aiming to evaluate the effect of tele-nursing practices based on technological competence theory on empowerment status and symptom management self-efficacy in breast cancer patients. The research will be carried out between September 2023 and March 2024 with patients diagnosed with breast cancer, who are receiving chemotherapy on an active basis, registered in the Medical Oncology Polyclinic of Atatürk University Health Research and Application Center. The sample of the study will consist of 70 people, 35 of which are in the experimental group and 35 in the control group. Afterwards, approximately 11 weeks of tele-nursing practices, including training, counseling and tele-monitoring based on the theory of technological competence, will be given to the experimental group. While preparing the content of tele-nursing practices, national and international literature will be scanned. In line with the literature; Training, consultancy and follow-up will be provided on breast cancer, problems experienced in the treatment process of breast cancer, the most frequently experienced chemotherapy symptoms and management strategies. Before starting the training program, a training booklet will be distributed to the patients and shared as an e-booklet. Within the scope of the training program, a five-week training will be held once a week via "Google Meet". After the training program is completed, the counseling and telemonitoring process will begin. In this process, a previously prepared consultancy guide will be used. Counseling and telemonitoring will cover 2 chemotherapy cycles (approximately 6 weeks). Within the scope of the application, the entire experimental group will be individually phoned on the 7th day after receiving a chemotherapy course. Information about the individual conditions of the patients and the instant status changes regarding the symptoms will be obtained and their questions will be answered in line with the previously created counseling guide. Patients will be informed that at any time other than the specified days, the questions of the patients regarding the instantaneous situation changes will be answered. After the completion of the tele-nursing practices, post-test measurements will be made with the Cancer Empowerment Scale and the Chemotherapy Symptom Management in Breast Cancer-Self-efficacy Scale of the experimental and control groups, and the feedback of the patients in the experimental group regarding the implementation process will be received. No attempt will be made to the individuals in the control group during the research process. Keywords: Tele-nursing, Technological Competence Theory, Breast Cancer, Cancer Empowerment, Symptom Management
NCT05998655 — Breast Cancer Female
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT05998655/
Awareness Scale Related To Physiotherapy After Breast Cancer: A Scale Development Study
In this study, the aim is to develop a scale that assesses the awareness levels of particularly short and/or long-term effects, especially related to physiotherapy, in individuals diagnosed with high incidence and survival rates of breast cancer.
NCT05992441 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05992441/