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Chemotherapeutic Toxicity clinical trials

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NCT ID: NCT06449625 Not yet recruiting - Inflammation Clinical Trials

Semaglutide in Auto-HSCT

PROTECT
Start date: August 12, 2024
Phase: Phase 2
Study type: Interventional

The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT. Study design: The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study. Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up. Study population: A planned total number of 40 patients will be randomized.

NCT ID: NCT06440811 Recruiting - Gastric Cancer Clinical Trials

Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer

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

The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT Regimen with PD-1 antibody in localized deficient mismatch repair gastric cancer. The main question it aims to answer are: - Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody versus FLOT regimen with PD-1 antibody for the treatment of localized deficient mismatch repair gastric cancer - Disease-free survival of preoperative adjuvant SOX plus PD-1 antibody and FLOT plus PD-1 antibody for dMMR and locally advanced gastric cancer. Participants will be divided into two groups to use a FLOT chemotherapy regimen plus PD-1 antibody and a SOX chemotherapy regimen plus PD-1 antibody. Researchers would compare tumor regression grade, adverse effects and survival benefit of two preoperative adjuvant regimens.

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: NCT06387901 Not yet recruiting - Breast Cancer Clinical Trials

Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.

PABTOX
Start date: May 6, 2024
Phase:
Study type: Observational

This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects. The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices. The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer. In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life.

NCT ID: NCT06357871 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer

NEPHROTOX
Start date: November 28, 2023
Phase:
Study type: Observational

Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series. Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA. We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.

NCT ID: NCT06270667 Recruiting - Clinical trials for Cardiovascular Diseases

Effects of Exercise Training in Survivors of Lymphoma

LYMfit
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.

NCT ID: NCT06197581 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

RADIOCOM
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy,despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall / breast ± lymphatic drainage area and requiring capecitabine, CDK 4/ 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.

NCT ID: NCT06041477 Recruiting - Clinical trials for Hepatocellular Carcinoma

Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC

HAIC
Start date: September 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare HAIC concurrently with sequentially combined with targeted and immunotherapies in terms of efficacy and safety in patients with potentially resectable intermediate and advanced HCC (CNLC stage IIa~IIIa). The main questions it aims to answer are: - Does a "strong combination" regimen of three simultaneous treatments (HAIC, targeted agents and immunotherapy) definitely result in a higher surgical conversion rate and better survival benefit? - Can the combination of targeted and immunotherapies based on patients' response to HAIC therapy avoid over-treatment of some patients without affecting the surgical conversion rate and overall survival? Participants will be randomly assigned to receive either HAIC concurrently or sequentially combined with targeted and immunotherapies. Researchers will compare concurrent treatment group with sequential treatment group to see if there are different in terms of the conversion resection rate, long-term survival, and safety.

NCT ID: NCT06012253 Recruiting - Clinical trials for Chemotherapeutic Toxicity

The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.

NCT ID: NCT05959720 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

BRALLA
Start date: September 5, 2023
Phase:
Study type: Observational [Patient Registry]

In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic/follow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.