Clinical Trials Logo

Chemotherapy Effect clinical trials

View clinical trials related to Chemotherapy Effect.

Filter by:

NCT ID: NCT06451393 Recruiting - Gastric Cancer Clinical Trials

Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

Start date: February 1, 2013
Phase:
Study type: Observational

This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.

NCT ID: NCT06441240 Recruiting - Breast Cancer Clinical Trials

Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.

NEORISK
Start date: November 1, 2023
Phase:
Study type: Observational

INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer. The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes. Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment. In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT. Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.

NCT ID: NCT06435767 Recruiting - Chemotherapy Effect Clinical Trials

Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy

Start date: January 1, 2024
Phase:
Study type: Observational

Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it. log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients. In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.

NCT ID: NCT06430177 Not yet recruiting - Cancer Clinical Trials

The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Cancer is a fatal disease characterized by uncontrolled growth and proliferation of tissues and organs in the human body. Among cancer treatments, chemotherapy is the most commonly used treatment method. The drugs used in chemotherapy cause vascular toxic effects during administration, frequent blood samples taken from the patient, antibiotic treatments applied, parenteral nutrition treatments. Subcutaneous venous port catheter (SCVPK), which is a permanent and long-term vascular access route that can be used for medical purposes and in emergency situations, is a frequently preferred and safe intravenous access route because it is not visible outside the body, is well tolerated by the patient, and has a low risk of infection. However, invasive procedures such as port needle insertion and replacement can also cause pain, anxiety and changes in vital signs in patients. Nowadays, the use of non-pharmacological approaches as well as pharmacological methods is increasing in the management of symptoms such as anxiety before the invasive procedure and pain during application in patients receiving chemotherapy treatment. These approaches improve the quality of life of patients and have a positive physiological effect. One of these approaches is sujok therapy. In Su Jok application; The reflection points of the organs are on the hands and feet. These points reflect to the body organ in that area and healing occurs. By finding the right point, energy flow is provided by massaging with appropriate applicators. This research will be conducted to examine the effect of Sujok therapy on pain intensity and anxiety level in cancer patients who have undergone port catheter placement. The research will be conducted as a randomized experimental and placebo study with a pretest-posttest control group in the oncology service of Fethi Sekin City Hospital. 90 (30 experimental, 30 control, 30 placebo) cancer patients who accept the research and meet the sample criteria of the study will be subjected to port catheter application. Application areas for pain, anxiety and stress before the port catheter to the patients in the experimental group will be determined with the help of a probe (diagnostic stick), and seeds will be added to these points approximately 45 minutes before the application and fixed with a patch. For cancer patients in the placebo group, the same procedure will be performed with seeds that have a neutral effect on the body. No procedure will be applied to the patients in the control group. Patient Information Form, General Comfort Scale (GAS), Visual Analog Scale -Pain (VAS-P), Visual Analog Scale -Anxiety (VAS-A) and State-Trait Anxiety Scale were used as data collection tools. (DSKÖ) scale will be used. SPPS 21.0 (Statistical Programme for Social Sciences) package program will be used to evaluate the data obtained from the research. It is thought that if the objectives of the study are achieved, it will help reduce the level of pain and anxiety that may occur during and after port catheter application. In addition, it will contribute to the professional advancement of the project manager, which is a career development project. The positive results in this study will guide other interventions to increase the comfort level of cancer patients who will undergo port catheterization and reduce the level of pain and anxiety.

NCT ID: NCT06429189 Not yet recruiting - Breast Cancer Clinical Trials

Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer

Start date: November 10, 2024
Phase: N/A
Study type: Interventional

Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy <85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed. Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy <85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed. Purpose. This study will be a 2-arm pragmatic randomized controlled trial, Home-Combo, which will target Portuguese women with a breast cancer diagnosis undergoing either neo-adjuvant or adjuvant chemotherapy. The Home-Combo study primarily aims to investigate the effects of a structured, supervised, home-based combined exercise intervention with self-selected intensity, conducted across the chemotherapy treatment period, on the chemotherapy completion rates of women with BC. Secondly, this study intends to analyze the impact of this intervention on functional performance, body composition, PA levels, and quality of life. A 3-month follow-up will be performed to investigate short-term outcomes and active lifestyle sustainability post-intervention. Methods. A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments. The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy. Outcome measures will be obtained at baseline, mid-treatment (≈3 months), post-intervention (≈6 months), and 3-month follow-up. A mediation analysis will also be conducted. Hypothesis 1: Women in the intervention will have a better completion rate than those in the control group. Hypothesis 2: Women in the intervention will present better functional performance, body composition, PA levels, and quality of life than the control group. Hypothesis 3: In the post-intervention period, women in the intervention group will maintain a more physically active lifestyle than women in the control group.

NCT ID: NCT06421610 Recruiting - Quality of Life Clinical Trials

OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

Start date: September 15, 2023
Phase: Phase 1
Study type: Interventional

This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).

NCT ID: NCT06410625 Recruiting - Chemotherapy Effect Clinical Trials

Evaluation of Response by FLT PET in Mesothelioma

FLT-MM
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Pleural mesothelioma (MPM) is an aggressive tumor that affects the pleura and originates from mesothelial cells. If untreated, median survival is 4-12 months following diagnosis. Asbestos exposure is a risk factor associated with 80% of cases. After the 1980s, regulations controlling the use of asbestos ensured that cases were limited. Approximately 3,000 new cases are diagnosed each year in the United States. In general, a minority of patients are candidates for surgery at the time of presentation, so the mainstay of treatment is systemic chemotherapy. For patients who are surgical candidates, surgery is usually part of a multimodal treatment process that also includes chemotherapy and/or radiotherapy. Early and accurate diagnosis has a critical impact on the management of the disease due to limited response to multimodal treatments. Patients are often diagnosed at an advanced stage, leading to poor overall survival. Thorax and upper abdomen CT imaging are standard initial imaging modalities for clinical staging of MPM. Although CT identifies the general extent of the primary tumor, it may not definitively identify some areas of tumor invasion. There may be difficulties especially in the evaluation of chest wall and diaphragm invasion. 18F-FDG PET/CT has been widely used for cancer diagnosis, staging, treatment response and prognostic information for many years with high accuracy rates. 18F-FDG PET/CT provides valuable information on differentiating benign and malignant pleural abnormalities, evaluating the possibility of malignant involvement of mediastinal and hilar lymph nodes, and detecting distant metastases. 18F-FDG PET/CT identifies metastatic disease undetected on CT in approximately 10% of patients. At the same time, the degree of involvement (SUV) in FDG PET plays a role in predicting disease prognosis. 18F-FDG PET/CT can also be used to evaluate the treatment response in patients receiving chemotherapy, but due to chemotherapy-related inflammatory changes, it is necessary to wait at least 2 weeks to evaluate the treatment response. 18F-Fluorothymidine (FLT) is a thymidine kinase 1-specific substrate that is increased in proliferating cells and is associated with the Ki-67 index, a proliferation marker. It allows noninvasive evaluation of cell proliferation, especially the early evaluation of the response to cytotoxic chemotherapy. 18F-FLT PET/CT imaging has shown success in early evaluation of response to systemic endocrine, chemotherapy, radiotherapy and combined chemotherapy in multiple tumor types. The prognostic value of a decrease in 18F-FLT uptake after initiation of treatment has also been reported. In this study, it is aimed to evaluate the success of 18F-FLT PET/CT in the early evaluation of the response after the first cycle of chemotherapy in patients diagnosed with mesothelioma and receiving systemic chemotherapy. It is also aimed to evaluate the prognostic value of response evaluation made with this method. It is planned to prospectively include 25 patients with MPM who scheduled for chemotherapy in the study. Included patients will undergo 18F-FDG PET/CT before chemotherapy followed by 18F-FLT PET/CT imaging within two weeks. 18F-FLT PET/CT will be performed on the 4th day after the 1st cycle of chemotherapy. After chemotherapy is completed, treatment response will be evaluated with 18F-FDG PET/CT. Patients will then be followed by their clinicians for relapse and progressive disease. Thus, the success of early 18F-FLT PET/CT in predicting end of treatment response will be evaluated.

NCT ID: NCT06376604 Recruiting - Chemotherapy Effect Clinical Trials

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Start date: September 8, 2021
Phase: N/A
Study type: Interventional

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

NCT ID: NCT06370234 Completed - Breast Cancer Clinical Trials

The Prediction Model of NAC Response for Breast Cancer Based on The Parametric Dynamics Features.

Start date: April 21, 2015
Phase: N/A
Study type: Interventional

The main purpose of this study is to develop a computer-aided prediction model for NAC treatment response. Based on the heterogeneity of internal parametric tumor composition commonly observed, this study will utilize the histologic characteristics and treatment response to investigate the image features as input data for predicting treatment response using Deep Learning technology. Using this technique, preoperative treatment evaluation may be facilitated by tumor heterogeneity analysis from developed dynamic radiomics, and the possibility of personal medicine can be realized not far ahead. In the first two years of this study using images from DCE-MRI, PET/CT and QDS-IR, we plan to develop the image processing algorithms, including segmenting breast and tumor region, extracting image feature which reflects angiogenic properties and permeability of tumor, which are highly correlated with NAC treatment response. During the third year of the project, the morphology and texture features from first two years can be combined for PET/MRI and prediction model can be achieved in accordance with the features extracted from dynamic features extraction using longitudinal images of PET/MRI.

NCT ID: NCT06313203 Recruiting - Chemotherapy Effect Clinical Trials

HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

TOMCAT
Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution. Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design