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Breast Cancer clinical trials

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NCT ID: NCT05196269 Not yet recruiting - Breast Cancer Clinical Trials

Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

CINDERELLA
Start date: June 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, for different patients, undergoing the same surgery, the aesthetic outcome could be completely different based on individual patient's factors (e.g, age, body habitus). In the CINDERELLA trial the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for classification of aesthetic outcomes and matching data and photographs) integrated in CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial the investigators plan to compare if the application helped to fulfil the expectations and lead to better quality of life compared with the classical approach. In the classical approach (control arm) doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about surgery and possible outcomes. In the majority of centers no photographic evaluation is done and expectations are not measured. The CINDERELLA trial will help to overcome any miscommunication and potential boundaries in patient's or physician's understanding of the potential outcomes of locoregional treatment of breast cancer.

NCT ID: NCT05196087 Not yet recruiting - Breast Cancer Clinical Trials

Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)

NIP IT!
Start date: March 2022
Phase:
Study type: Observational

Patients who have undergone curative treatment may be at risk of relapse. This study will collect, annotate, and sequence biospecimens (blood, stool, and tissue) from patients across different tumor types to detect molecular residual disease (MRD) before metastases become radiographically or clinically detectable. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types.

NCT ID: NCT05193149 Not yet recruiting - Breast Cancer Clinical Trials

Inspiratory Muscle Training in Obese Breast Cancer Survivors

IMOCS
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in stage 0-III obese breast cancer survivors. The investigators central hypothesis is that obesity promotes exercise intolerance via obesity-related impaired breathing mechanics and that inspiratory muscle training will be effective in improving impaired breathing mechanics and exercise tolerance..

NCT ID: NCT05192525 Not yet recruiting - Breast Cancer Clinical Trials

The Effects of a Nurse-led mHealth Program for Symptom Self-management of Breast Cancer Patients Undergoing Chemotherapy

mChemo
Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Breast cancer (BC) survivors will experience multiple symptoms following chemotherapy. During the pandemic of COVID-19, the closure of clinics and fear of infection lead to BC patients' challenges in self-managing their multiple symptoms in home settings. Mobile health (mHealth), without time and space limitation, plays a positive role in supporting self-management and treatment compliance. However, previous mHealth self-management studies did not report sustained beneficial effects with physician-led supervision. In oncology practice, the nurse-led model of patient self-management for breast cancer has been placed on greater emphasis. Accordingly, an innovative nurse-led supervised mHealth program was designed to support self-management for BC patients undergoing chemotherapy. This pilot study aims to examine the feasibility and acceptability of a nurse-led mHealth-based self-management program for BC patients receiving chemotherapy, in order to provide evidence for conducting a definitive trial. The feasibility outcomes of the pilot study include subject eligibility rate, recruitment rate, and retention rate. The efficacy outcomes relate to self-efficacy (primary outcome), symptom distress and frequency, as well as health-related quality of life, and healthcare utilisation. The qualitative outcomes encompass patient- and provider-users' perceptions of the app usability and subjects' experiences of engaging in the pilot study.

NCT ID: NCT05192278 Recruiting - Breast Cancer Clinical Trials

Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management

Start date: December 12, 2021
Phase: Phase 2
Study type: Interventional

Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome. Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery. Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques. Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks. ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae. The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.

NCT ID: NCT05191914 Not yet recruiting - Breast Cancer Clinical Trials

Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors

Start date: February 7, 2022
Phase: Phase 4
Study type: Interventional

The trial used a multicenter, open, single-arm design in which patients were treated with Chidamide combined with Fulvestrant.The primary objective is to evaluate the preliminary efficacy and safety of Chidamide in combination with Fulvestrant.Patients included in the trial were advanced breast cancer progressing on first-line aromatase inhibitor + Cyclin-dependent kinases(CDK)4/6i rescue therapy.

NCT ID: NCT05191004 Not yet recruiting - Breast Cancer Clinical Trials

Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

Start date: March 2022
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

NCT ID: NCT05190978 Not yet recruiting - Breast Cancer Clinical Trials

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

NCT ID: NCT05190770 Recruiting - Breast Cancer Clinical Trials

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.

NCT ID: NCT05189535 Recruiting - Clinical trials for Breast Cancer Female

"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

Start date: October 3, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.