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Cancer, Breast clinical trials

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NCT ID: NCT05843539 Recruiting - Quality of Life Clinical Trials

Adverse Childhood Experiences, Adaptation and Breast Cancer

CAPONE
Start date: April 12, 2022
Phase:
Study type: Observational

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase. ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications. The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

NCT ID: NCT05830097 Recruiting - Cancer, Breast Clinical Trials

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

Start date: March 14, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.

NCT ID: NCT05800834 Recruiting - Wounds and Injuries Clinical Trials

Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds

MorphineGEL
Start date: September 12, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is: • Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days. The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.

NCT ID: NCT05721976 Recruiting - Obesity Clinical Trials

With Love, Grandma ("Con Cariño, Abuelita") Pilot Study

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.

NCT ID: NCT05711030 Recruiting - Breast Cancer Clinical Trials

Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery

TPVB
Start date: November 4, 2022
Phase: N/A
Study type: Interventional

Background: Mastectomies are traditionally performed under general anesthesia (GA), often with the addition of regional anesthesia for post-operative pain relief. Thoracic paravertebral blocks (TPVB) had previously been described in the literature to be sufficient for intra-operative anesthesia as an alternative to GA. A 2021 literature review by Cochrane Library comparing paravertebral anesthesia (with or without sedation) to general anesthesia for patients undergoing oncologic breast surgery showed that TPVB could reduce post-operative nausea and vomiting (PONV), hospital stay, postoperative pain and time to ambulation. It also resulted in greater patient satisfaction compared to GA. The aim of this study is to demonstrate the efficacy of single-injection TPVB done under ultrasound guidance for patients undergoing breast cancer surgery without axillary node dissection. Hypothesis: Single-injection thoracic paravertebral block is non-inferior to multiple (3) injections for oncologic unilateral breast surgery anesthesia. Methods: The current study is a prospective randomized controlled trial of patients undergoing oncologic breast surgery without axillary node dissection or immediate reconstruction. Patients will be randomized into two groups; thoracic paravertebral block (TPVB) single-injection or TPVB multiple (three) injections. Significance/Importance: Oncologic breast surgery performed under TPVB and sedation lowers the risks of post-operative nausea and vomiting, decreases peri-operative use of narcotics, decreases pain scores at rest and on mobilization and leads to better overall patient satisfaction when compared to GA. It also leads to shorter hospital stays. Most studies use multiple injections to perform the block. Even though the risks associated with TPVB are low (3.6 per 1000 surgeries), the single-injection technique could reduce the risks even more. One injection is also easier to perform and of shorter duration, leading to greater patient tolerance and less side effects related to blocks performance duration such as vaso-vagal reactions or general discomfort. To date, no studies have compared the efficacy of single-injection paravertebral block and multiple injection techniques as the main modality of anesthesia for breast cancer surgery.

NCT ID: NCT05639829 Completed - Cancer, Breast Clinical Trials

Time-restricted Eating in Survivors Trial

TEST
Start date: August 5, 2020
Phase: N/A
Study type: Interventional

Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.

NCT ID: NCT05573022 Recruiting - Cancer, Breast Clinical Trials

Impact of a Patient Decision Aid Intervention

IMPACTT
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.

NCT ID: NCT05424666 Recruiting - Cancer, Breast Clinical Trials

The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

Start date: December 19, 2022
Phase: N/A
Study type: Interventional

The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

NCT ID: NCT05410002 Active, not recruiting - Cancer Prostate Clinical Trials

Diet Effect on Cancer Treatment Outcome

Start date: October 12, 2022
Phase: Phase 1
Study type: Interventional

The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

NCT ID: NCT05409352 Recruiting - Fatigue Clinical Trials

Self-administered Acupressure to Improve Cancer-related Fatigue Among Cancer Patients Undergoing Chemotherapy

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

The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.