Clinical Research Directory

Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.

The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy. The main questions it aims to answer are: Does ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)? What are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)? Participants will: Undergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla. Receive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals. Continue their designated standard rehabilitation program, including range-of-motion and stretching exercises. Attend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.

Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer

The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.

Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment

Approximately 200 English- or Spanish-speaking women newly diagnosed with stage I-III breast cancer will be randomized to either receive access to an online sexual health video series or receive usual care. Participants will complete surveys at baseline and every two months for six months, measuring self-efficacy in patient-provider communication and perceived barriers to discussing sexual health. Electronic health record review will assess utilization of sexual-health-related medical and supportive services. A subset of participants will participate in qualitative interviews to explore their sexual health experiences during treatment and, for those receiving the intervention, the perceived impact of the videos.

Step Count and Treatment Response in Neoadjuvant Breast Cancer

This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.

Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA)

This randomized, controlled, single-center trial investigates the effects of auricular acupressure, administered according to the National Acupuncture Detoxification Association (NADA) protocol, on perioperative anxiety and pain in patients with a first diagnosis of breast cancer undergoing therapeutic breast surgery. Participants receiving auricular acupressure according to the NADA protocol will be compared with patients receiving standard care alone.

Adjuvant Intensification for LAR

This study enrolled patients with early-stage triple-negative breast cancer who had undergone radical surgery. The postoperative pathology met the TNM staging criteria of pT1c-3N0-3M0, and immunohistochemistry (IHC) results confirmed ER-negative status (IHC showed \<1% of tumor cells positive for ER), PR-negative status (IHC showed \<1% of tumor cells positive for PR), and HER2-negative status (IHC intensity of 0 or 1+; or IHC intensity of 2+ but with negative in situ hybridization results). Additionally, patients either exhibited high AR expression (IHC showing AR ≥10%) or were classified as the LAR subtype based on digital pathology. This study plans to prospectively enroll 904 subjects, who will be randomized in a 1:1 ratio after completing standard chemotherapy. They will be allocated to either the standard-of-care (SOC) chemotherapy followed by everolimus group or the SOC-alone group. The study aims to evaluate the efficacy of SOC chemotherapy followed by everolimus versus SOC chemotherapy alone as adjuvant therapy for patients with early-stage radically resected triple-negative breast cancer of the LAR subtype, with the primary endpoint being 3-year invasive disease-free survival (iDFS).

The Effect of Group and Mobile Wellness Coaching Given to Women With Breast Cancer on the Disease

It is believed that this study will serve as a model for a Wellness Coaching program delivered to patients newly diagnosed with breast cancer via a mobile application and contribute to the literature. No other studies have been found in the literature examining the effects of a model-based Wellness Coaching program on the psychosocial adjustment to the disease and well-being of patients newly diagnosed with breast cancer. This demonstrates the originality of this study. In all these respects, it is believed that the study will contribute to the literature and serve as a guide for future studies on the subject. The purpose of this doctoral dissertation is to determine the effects of Mobile Wellness Coaching and Group Wellness Coaching programs on the psychosocial adjustment to the disease and well-being of women newly diagnosed with breast cancer.

Avocado Consumption and Cellular Aging in Breast Cancer Survivors

Women with breast cancer are at increased risk of comorbidities and premature mortality, potentially due to accelerated biological aging. Telomere attrition has been proposed as a biomarker of this process, which could be mitigated through interventions targeting behavioral factors such as diet. In recent years, avocado has drawn attention in nutritional research due to its unique nutritional profile. Main objective: To evaluate the effect of consuming one avocado per day on biological aging-measured by telomere length-in breast cancer survivors, compared to a habitual diet (less than two avocados per week). Secondary objectives include changes in telomerase activity and biomarkers of inflammation and oxidative stress. Additional objectives include classical cardiovascular disease markers (glucose metabolism, lipid profile, blood pressure); anthropometric measurements; quality of life and fatigue; and diet quality. Methodology: A randomized controlled parallel-group trial involving 120 breast cancer survivors. Participants will be randomly assigned to either the intervention group (one avocado per day) or the control group (habitual diet with fewer than two avocados per week) and followed for 4 months. At baseline and the end of the intervention, a general questionnaire will be administered; blood and urine samples will be collected; anthropometric and blood pressure measurements will be taken; and diet, physical activity, quality of life, and fatigue will be assessed. Mean changes from baseline to the end of the intervention in the primary outcome (telomere length) and secondary outcomes (inflammation, oxidative stress, classical cardiovascular disease markers, anthropometric measures, quality of life, and diet) will be compared between the intervention and control groups using linear regression models.

Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors

The overall aim of this study is to identify and characterize anti-NaV1.5 autoantibodies in patients with metastatic breast and colorectal cancer. These tumors are characterized by the presence of a specific target structure (called nNaV1.5) against which antibodies are produced. These antibodies may cross-react with a similar structure (called NaV1.5) that is found in the heart. This could affect channel function and increase the risk of arrhythmias.

Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis

In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and/or tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. In addition, vitamin K promotes gamma-carboxylation of osteocalcin, causing its activation and leading to increased incorporation of hydroxyapatite into the bone, resulting in increased calcium uptake from the blood and other tissues. Studies have reported that a combination of alendronate and vitamin K2 can lead to a decrease in the ratio of uncarboxylated osteocalcin to carboxylated osteocalcin, contributing to an increase in BMD, especially in the femoral neck. α-lactalbumin is able to increase the bioaccessibility of calcium due to its ability to prevent its precipitation at the neutral pH present in the absorptive tracts of the small intestine. Furthermore, α- lactalbumin has a binding site for vitamin D3, and the complexes formed by monomers of this protein and vitamin D have shown good stability in the presence of high vitamin concentrations. Inositol is a carbohydrate structurally similar to glucose which, in its isomeric form D-chiro-inositol, acts on bone remodeling by blocking the activation of osteoclasts through inhibition of the binding of RANK-L to its receptor present on pre-osteoclasts. Our hypothesis is that the use of the combination of vitamin K, α- lactalbumin, and D-chiro-inositol should improve the intestinal absorption of calcium and vitamin D, increasing the percentage of patients able to normalize serum levels of vitamin D and urinary calcium excretion (as a parameter of adequate calcium intake). This aspect, together with the direct effect of these components on bone remodeling, could enhance the anti-resorptive effect of standard therapy with bisphosphonates, improving the quantitative and qualitative parameters of bone. Therefore, we design a prospective randomized pilot study to assess efficacy of the combination of vitamin K, α-lactalbumin, and D-chiro-inositol, comparing patients with standard therapy and patients treated with Synostea®

Physical Exercise on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors

The goal of this clinical trial is to evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. The main questions it aims to answer are: Will the intervention reduce body weight, body fat, and visceral adiposity? Will it improve cardiorespiratory fitness, motor performance, gut microbiota composition, and quality of life? Researchers will compare women participating in the dance and nutrition program with a control group who maintain their usual lifestyle to see if the intervention leads to favorable metabolic, physical, and microbiome-related changes. Participants will: Attend supervised dance classes three times per week for 12 weeks. Follow an individualized nutrition plan tailored to their resting metabolic rate. Provide blood and stool samples, complete fitness tests, and answer quality-of-life questionnaires before and after the intervention.

Short-term Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer

Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. While there is a clear linear relationship between the duration of aromatase inhibitor use and the cumulative incidence of cardiovascular events and mortality, the underlying mechanisms contributing to this risk remain unknown. This study will characterize the short-term effects of aromatase inhibitor therapy on established and novel health indices for cardiovascular diseases in breast cancer patients. Using a longitudinal case-control design this study will assess the effects of short-term (first 6 months) aromatase inhibitor use in breast cancer patients compared to age- and BMI-matched controls, aiming to determine the cardiovascular, metabolic, and behavioural health impacts of endocrine treatment during this early period. Specifically, our objectives are as follows: 1. To examine the effects of aromatase inhibitor therapy on early risk indicators for cardiovascular disease in the peripheral vasculature and heart, including blood biomarkers (lipids), blood pressure, aortic and peripheral stiffness, carotid artery stiffness and intima media thickness, endothelial function, and left ventricular ejection fraction, longitudinal strain, volumes, and mass, including the responsiveness of the cardiovascular system to an oral glucose tolerance test, in breast cancer survivors compared to controls. 2. To examine the effects of aromatase inhibitor therapy on factors related to cerebrovascular health, autonomic regulation, and cognitive function, including BDNF, heart rate variability, cerebrovascular function in response to a supine-sit-stand maneuver and squatting challenge, and a core battery of cognitive function tests, in breast cancer survivors compared to controls. 3. To examine the effects of aromatase inhibitor therapy on body composition and bone mineral density, along with assessments of glycemic regulation in response to an oral glucose tolerance test and in 24h periods of free-living (continuous glucose monitoring), in breast cancer survivors compared to controls. 4. To examine the effects of aromatase inhibitor therapy on lifestyle factors (behavioural), including diet, physical activity (including cardiorespiratory fitness), sleep, stress, and quality of life, in breast cancer survivors compared to controls. The investigators hypothesize that cardiovascular and metabolic health outcomes will be similar between breast cancer survivors and controls at baseline but will deteriorate relative to controls within the first 6 months of aromatase inhibitor therapy.

A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer

The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens. The main questions it aims to answer are: 1. What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy? 2. What is the impact of OFS treatment duration on patient prognosis? Participants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.

Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy

Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are: 1. To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy; 2. To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.

Effects of a Group Versus Individual Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Breast Cancer Patients Undergoing Active Treatment

Introduction: The significant improvement in breast cancer survival, largely attributable to biomedical and technological progress, makes it increasingly necessary to investigate the secondary effects linked to this pathology. Among these, cancer-related cognitive impairment (CRCI) stands out as one of the most frequent yet frequently overlooked complications. Objective: To evaluate the impact of a structured cognitive training program on the management of CRCI in patients with breast cancer receiving active treatment. Methodology: A randomized controlled clinical trial will be conducted with two arms: an Intervention Group (IG) and a Control Group (CG). The study will include patients with a recent diagnosis of breast cancer. Based on sample size calculations, 50 participants will be recruited-25 per group-to detect a minimum difference of 2.95 points on the MoCA (Montreal Cognitive Assessment), a tool commonly used to assess cognitive performance. All participants will receive an informational leaflet aligned with the latest WHO recommendations for preventing cognitive decline. In addition, the IG will complete an individualized cognitive training (CT) program focused on everyday cognitive skills (EC). The program will provide a dossier with 80 training sessions, structured into four phases (P1-P4) of 20 activities each, to be implemented monthly. Baseline assessments and a follow-up four months after the intervention will be carried out in both groups. Variables collected will include sociodemographic and clinical data, as well as outcome measures for cognitive status (MoCA), everyday cognition (PECC), anxiety levels (Hamilton scale), functional capacity (LB), sleep quality (PSQI), quality of life (ECOG), and subjective memory complaints (FACT-COG). Impact: Findings from this study could support the development of targeted cognitive rehabilitation strategies and the implementation of clinical protocols for individuals undergoing breast cancer treatment. By addressing CRCI-an underrecognized but increasingly prevalent issue given rising survival rates-these interventions may contribute to improving patients' overall quality of life.

Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma

This study addresses a critical gap in the care of older women with breast cancer, a population often underrepresented in clinical research despite their increased vulnerability to treatment-related complications. By examining the relationship between frailty and health-related quality of life (QOL), the study aims to provide evidence-based insights into how geriatric assessments can guide personalized treatment decisions, ensuring that therapeutic benefits outweigh risks. Given that older adults prioritize QOL over survival gains, understanding the impact of frailty on their well-being can help clinicians optimize care plans, reduce adverse outcomes, and improve overall patient-centered outcomes. The findings may also inform the integration of routine geriatric assessments in oncology practice, ultimately enhancing the management of older cancer patients in resource-limited settings like Egypt.

The Effect of Animation-Based Education on Menopausal Women's Attitudes, Behaviors, and Screening Test Participation Regarding Breast Cancer

The aim of this study was to determine the effect of education provided to women in menopause through animation on their attitudes toward breast cancer, behaviors, and screening test participation. The study will include a total of 136 women in the menopausal period, comprising 68 experimental group participants and 68 control group participants who have applied to the Orduyeri and Kırtepe Family Health Centers affiliated with the Bartın Public Health Institution. Women who agree to participate in the project, which will run from January to August 2025, will receive 40-45 minute training sessions in a suitable room at the ASM. The training sessions will be conducted in groups of 8-12 people. The training content will include information about the purpose, duration, and rules of the training. After providing information about the project, a pre-test will be administered. Through face-to-face interviews, researchers assigned to the project will show animated videos enriched with sound and images via an online program they have prepared. These videos will be 10-12 minutes long, and an interim test will be conducted. Three months after the pre-test, the women participating in the study will be contacted, and a final test will be administered in their own homes. Project data will be collected using the Personal Information Form, Champion Health Belief Scale, and Breast Cancer Awareness Scale. Descriptive statistics, independent sample t-tests, chi-square tests, and repeated measures analysis of variance (ANOVA) tests will be used in the statistical analysis of the project.

One-day Mind Programme for Women With Breast Cancer

Breast cancer (BC) remains the second most common type of cancer worldwide and the leading cancer affecting women. In Portugal there are approximately 7000 new diagnoses of BC each year. The diagnosis and treatment of BC can profoundly impact patients' physical (e.g., fatigue, pain) and psychological (e.g. distress, depressive symptoms) well-being. Psychological interventions that foster adjustment to cancer (and to its treatment), mental health and quality of life are therefore essential. The use of contextual behavioural therapies in samples of people with chronic diseases has shown evidence of efficacy in improving psychopathological symptoms. Additionally, a recent meta-analysis concluded that the use of single-session ACT interventions in samples with chronically ill patients may be more viable, acceptable, and beneficial compared to multiple-session ACT interventions. This interventional study aims to test the acceptability (aim 1) and effectiveness (aim 2) of a brief (7-hour) version of the "Mind Programme for Women with Breast Cancer", which is providing promising efficacy results. Similarly to the original programme, this brief version integrates contextual behavioural therapies (Acceptance and Commitment Therapy - ACT, and Compassion-Focused Therapy - CFT), is tailored to BC women and presents a group and online format, delivered by two psychologists. This trial also aims to determine the contribution of mediating (psychological flexibility, self-compassion) and moderating (e.g. age) factors in treatment effectiveness (aim 3). Women with BC who had previously shown interest in participating in the RCT of the (original) multiple-session Mind Programme, but that were either not eligible or were allocated to the waiting list, will be invited to join this trial. Participants will complete the 7-h intervention "One-day Mind Programme for women with breast cancer" and complete self-reported outcome measures (e.g. EORTC QLQ-C30, HADS, CompACT, SCS, resource use questionnaire) in three different timepoints (pre, post, and 3-month follow-up). The G\*Power 3.1.9.7 software was used to calculate the sample size (N=36) required for a single-armed linear repeated-measures model with three measurements and assuming a comparable (medium) effect size to that estimated in similar studies, an alpha of 0.05 and a minimum of 90% power. High levels of acceptability and improvements in outcomes (e.g. breast cancer-specific quality of life, anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related costs) are expected at post-treatment and follow-up. This trial seeks to contribute to the integration of brief and cost-effective psychosocial interventions in the usual healthcare for BC patients and survivors.

Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer

Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. Despite the evidence that aromatase inhibitor therapy is associated with increased risk of cardiovascular events, potentially related to the duration of use, no studies have been conducted to characterize the long-term effects of aromatase inhibitor therapy on the heart or vessel structure and function as underlying determinants of cardiovascular mortality. This study will characterize the long-term effects of aromatase inhibitor therapy on established and novel health indices for CVD in breast cancer patients, by examining cross-sectionally compare health indices 1-, 5- and 10-years post-diagnosis in breast cancer survivors to controls. Specifically, our objectives are as follows: 1. To examine the effects of aromatase inhibitor therapy on early risk indicators for cardiovascular disease in the peripheral vasculature and heart, including aortic stiffness (primary outcome) and secondary outcomes of peripheral and carotid artery stiffness, blood biomarkers (lipids), blood pressure, carotid intima media thickness, endothelial function, and left ventricular ejection fraction, global longitudinal strain, and left ventricular diastolic function, in breast cancer survivors compared to controls. 2. To examine the effects of aromatase inhibitor therapy on factors related to cerebrovascular health, autonomic regulation, and cognitive function, including BDNF, heart rate variability, cerebrovascular function in response to a supine-sit-stand maneuver and squatting challenge, and a core battery of cognitive function tests, in breast cancer survivors compared to controls. 3. To examine the effects of aromatase inhibitor therapy on body composition, bone mineral density, and protein metabolism, in breast cancer survivors compared to controls. 4. To examine the effects of aromatase inhibitor therapy on lifestyle factors (behavioural), including diet, physical activity (including cardiorespiratory fitness), sleep, stress, and quality of life, in breast cancer survivors compared to controls. The investigators hypothesize that biologic and behavioural cardiovascular health indices will be deteriorated relative to controls as early as 1 year post-diagnosis and that prolonged use will further accelerate aging-related impairments.