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Radiation Toxicity clinical trials

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NCT ID: NCT05203250 Recruiting - Cancer Clinical Trials

Longitudinal Registry Including Patients Treated With Heavy Particles

Start date: June 4, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia. By keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.

NCT ID: NCT05109819 Recruiting - Radiation Toxicity Clinical Trials

Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

ESO-SPARE
Start date: May 20, 2021
Phase: N/A
Study type: Interventional

Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL). The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities. 200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.

NCT ID: NCT05014191 Recruiting - Radiation Toxicity Clinical Trials

Treatment Positioning in Vulvar Cancer Radiation Therapy

Start date: July 1, 2020
Phase:
Study type: Observational

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.

NCT ID: NCT04948840 Recruiting - Breast Cancer Clinical Trials

Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis

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

Breast cancer is the most common cancer in the world. Half of patients with such cancer are treated with radiation therapy. Some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome. Several studies have shown a correlation between an inflammatory reaction and a protein, called TREM-1. But to date, no link has been proven between TREM-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer. Our study aims to understand the involvement of this TREM-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.

NCT ID: NCT04940936 Recruiting - Radiation Toxicity Clinical Trials

Shared Decision Making on Radiation Dose for Lung Malignancies

Start date: November 12, 2021
Phase: N/A
Study type: Interventional

A Patient Decision Aid (PtDA) is developed during a workshop in close collaboration with selected patients. The PtDA is subsequently used in the consultation between patient and physician to facilitate their shared decision on the dose of stereotactic body radiation therapy (SBRT) for lung tumors located less than 1 cm from the thoracic wall. Hypothesis: The use of a PtDA will increase the extent of Shared Decision Making (SDM) during the consultation and result in patients being more directly involved in the planning of their treatment.

NCT ID: NCT04880148 Recruiting - Xerostomia Clinical Trials

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

HONEY
Start date: November 3, 2021
Phase: N/A
Study type: Interventional

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.

NCT ID: NCT04867564 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Radiation-induced Cardiac Toxicity After Non-small Cell Lung Cancer Radiotherapy

Start date: May 1, 2021
Phase:
Study type: Observational

Despite the growing interest in investigating how the radiotherapy (RT) dose to anatomical substructures of the heart links to survival, the heart substructures at risk remain poorly defined. They are not delineated routinely as part of the RT planning process and there is no consensus on their dose constrains. With improving prognosis for non-small cell lung cancer (NSCLC) patients, the evidence relating irradiation of the heart to excess mortality has begun to accumulate. The study aims to evaluate subclinical cardiac dysfunction in consecutive NSCLC patients treated with definitive RT and to investigate the predictive value of the heart substructures dosimetric parameters for subclinical and overt cardiac toxicity as assessed using traditional and speckle tracking echocardiography (STE). The study will also investigate whether subclinical alterations detected by echocardiography with strain imaging may serve as a marker for future clinical dysfunctions.

NCT ID: NCT04831970 Recruiting - Radiation Toxicity Clinical Trials

POst-Prostatectomy Ablative Radiation Therapy

POPART
Start date: April 15, 2021
Phase:
Study type: Observational

The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (< 90 days from the end of treatment) and late (> 90 days) setting.

NCT ID: NCT04700527 Recruiting - Radiation Toxicity Clinical Trials

The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study

Start date: December 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess and compare GI toxicity from RT between subjects who receive therapeutic SCFA and those who receive placebo, in hopes of identifying a safe, low-cost therapeutic to reduce GI toxicity from therapeutic or environmental radiation.

NCT ID: NCT04670016 Recruiting - Radiation Toxicity Clinical Trials

HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers

Start date: July 2, 2020
Phase:
Study type: Observational [Patient Registry]

Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.