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Breast Neoplasms clinical trials

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NCT ID: NCT04842409 Completed - Breast Cancer Clinical Trials

Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery

SAFE-FORWARD
Start date: November 30, 2021
Phase:
Study type: Observational

SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost. All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales. Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.

NCT ID: NCT04841928 Completed - Breast Cancer Clinical Trials

Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The present study is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.

NCT ID: NCT04836520 Completed - Breast Cancer Clinical Trials

SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer.

Start date: August 2, 2021
Phase: Phase 2
Study type: Interventional

The study is being conducted to assess effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.

NCT ID: NCT04836221 Completed - Hypertension Clinical Trials

Comorbidities And Reducing inEquitieS

CARES
Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.

NCT ID: NCT04832386 Completed - Clinical trials for Breast Cancer Lymphedema

COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA

Start date: March 30, 2019
Phase:
Study type: Observational

Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With the advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity. The aims of the treatment of lymphedema are to reduce edema, prevent the increase of edema, prevent infections, protect skin integrity, range of motion and limb functions. Complete Decongestive Therapy (CDT) is recommended by the International Society of Lymphology (ISL) as the international contemporary standard treatment for BCRL(breast cancer related lymphedema) treatment. CDT is a treatment method that includes manual lymph drainage (MLD), multilayer bandaging (Multilayer, short-stretch compression bandaging), exercise, skin care and compression garment. Compression garments, which are the most important component of the second phase of CDT, reduce the interstitial pressure of the extremity with the pressure they apply, and reduce capillary filtration and lymph production. Regular use of compression garments is very important during the treatment process. It is recommended that compression garments be worn during all waking hours. The success of compression garments is closely related to the patient's compliance with the treatment. Patients with lymphedema may need to wear compression garments for life. Wearing compression garments may have some difficulties for patients and this may affect compliance and adherence to treatment. The aim of this study is to investigate the compliance to compression garments and related factors among patients with breast cancer-related lymphedema.

NCT ID: NCT04829890 Completed - Breast Cancer Clinical Trials

Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer

Start date: February 2004
Phase:
Study type: Observational

This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.

NCT ID: NCT04826367 Completed - Breast Cancer Clinical Trials

Relaxation Training by Tele-Rehabilitation in Patients With Breast Cancer

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

With developing treatment methods, oncological rehabilitation has become an important complementary part of cancer treatment. Due to the COVID-19 pandemic, the use of tele-rehabilitation has gained importance in terms of access to physical therapy in individuals with breast cancer. Considering the home environment and the patient profile, it is thought that relaxation exercises can be used in the most comfortable and safe way for patients to reduce the side effects of chemotherapy and can be used as home exercises whose effectiveness has been reported in the literature. The purpose of our study; to examine the effects of relaxation exercises performed by tele-rehabilitation on functional capacity, fatigue, emotional state, quality of life, cognitive status, sleep quality and kinesiophobia in breast cancer patients receiving chemotherapy. A total of 64 patients, will randomly be allocated to the exercise group (n = 32) and to the control group (n = 32). Participants will be evaluated at first appoinment and after 6 weeks of intervention. 'Brief Pain Questionnaire' for assessment of pain as assessment methods, 'Fatigue Impact Scale' for fatigue assessment, 'Hospital Anxiety-Depression Scale' for emotional state, 'EORTC QLQ-C30 Quality of Life Scale' for quality of life assessment, 'The FACT-Cog questionnaire' for cognitive state assessment, the' Pitsburg Sleep Quality Scale 'for the measurement of sleep quality, and the' Tampa Kinesophobia Scale 'for the assessment of kinesiophobia will be used.

NCT ID: NCT04824599 Completed - Breast Neoplasm Clinical Trials

Regional Anesthesia and Partial Mastectomy

Start date: February 19, 2021
Phase: N/A
Study type: Interventional

Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon. The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).

NCT ID: NCT04822597 Completed - Breast Cancer Clinical Trials

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Start date: April 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness four different pain treatments for the injection of radioactive tracer that women with breast cancer receive for sentinel lymph node biopsies. This study will include women who have been diagnosed with breast cancer and who will be undergoing sentinel lymph node biopsy with a standard injection of radioactive tracer before surgery. A participant's active participation will take place on two separate occasions. In the first occasion, a participant will complete a brief pain assessment on the day of enrollment. The rest of a participant's active participation will take place on one day (the day of surgery) and last approximately 20 minutes, after which active participation will end.

NCT ID: NCT04818996 Completed - Breast Cancer Clinical Trials

Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Start date: October 22, 2019
Phase: N/A
Study type: Interventional

In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.