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Radiotherapy Side Effect clinical trials

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NCT ID: NCT03885505 Not yet recruiting - Quality of Life Clinical Trials

An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients

Start date: June 25, 2019
Phase:
Study type: Observational

Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life

NCT ID: NCT03832803 Completed - Prostate Cancer Clinical Trials

Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. Tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. It is not uncommon for some men to have "accidents" during treatment causing understandable distress. This can also extend the treatment time and cause knock on delays in the radiotherapy department. Several United Kingdom (UK) centres report treating with an empty bladder. The investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.

NCT ID: NCT03742687 Recruiting - Clinical trials for Stage IV Non-small Cell Lung Cancer

Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

Start date: November 22, 2018
Phase: N/A
Study type: Interventional

The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment. The aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).

NCT ID: NCT03737500 Completed - Breast Cancer Clinical Trials

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

BLITE-01
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.

NCT ID: NCT03710733 Active, not recruiting - Clinical trials for Radiotherapy Side Effect

Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

NCT ID: NCT03703648 Recruiting - Clinical trials for Head and Neck Cancer

Post-radiation Dental Disease Amongst Head and Neck Cancer Patients

Start date: December 1, 2018
Phase:
Study type: Observational

Background Post-radiotherapy head and neck cancer (HANC) patients are at increased risk of dental caries and periodontal disease due to radiation-related damage to the teeth and salivary glands. Currently the exact aetiology of post-radiotherapy dental disease, and variation in its incidence and severity based on tumour location and radiotherapy dose, is poorly understood. Consequently there is a lack of clear guidance on how HANC patients should be dentally managed both before and after their radiotherapy. Aim The aim of this study is to quantify the relationship between dental radiation dose, 'spared' parotid gland radiation dose, tumour location, and post-radiotherapy dental disease. Methods A prospective cohort study will be undertaken in HANC patients treated with radiotherapy. A total of 215 patients will be recruited over a period of 2.5 years. Participants will be assessed and rendered dentally fit prior to radiotherapy in the School of Dentistry, Belfast. All patients will be followed-up at 6, 12, and 24-months post-radiotherapy. Data to be collected at each visit will include: total number of carious teeth, periodontal disease indices, salivary flow rates, diet, oral hygiene, mouth opening, xerostomia and oral health-related quality of life. Radiotherapy, including individual tissue-dose exposures, will be prescribed by the Clinical Oncology team as per current practice. Doses to the teeth and 'spared' parotid gland will be determined using radiotherapy research software (Non-Clinical Eclipse System sold by Varian Medical Systems UK Ltd). Using appropriate statistical tests, data analysis will determine the relationship between dental disease, radiation dose, and tumour location. Anticipated variation in the incidence and severity of post-radiotherapy dental disease based on the radiotherapy dose and tumour location, will inform the development of a clinical risk-assessment tool that will allow dentists to categorise patients as 'high' or 'low' risk of future disease. Guidelines regarding pre-radiotherapy dental extractions and post-radiotherapy preventative strategies will also be developed and will advise clinicians based on this risk assessment. A micro-costings study will be undertaken to evaluate patient and healthcare costs associated with the diagnosis and management of pre- and post-radiotherapy dental disease.

NCT ID: NCT03613506 Recruiting - Clinical trials for Radiotherapy Side Effect

The Role and Intervention of TGF-β in Abdominal Radiation Injury

Start date: October 25, 2019
Phase: Phase 2
Study type: Interventional

This project aims to investigate the relationship between radiation-induced the relationship between elevated peripheral blood TGFβ and complications of radiotherapy,and to analysis of changes in peripheral blood TGFβ levels after abdominal radiotherapy and its relationship with radiotherapy complications.Simultaneously,Patients who underwent abdominal radiotherapy were given captopril (sustained release) to block TGFβ,Whether it can reduce peripheral blood TGFβ levels and reduce radiotherapy complications,to explore the protective effect of blocking TGFβ secretion on normal tissues after radiotherapy.

NCT ID: NCT03534570 Recruiting - Heart Diseases Clinical Trials

Gated Radiotherapy in Left Sided Breast Cancer Patients

GATTUM
Start date: May 2018
Phase:
Study type: Observational

To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.

NCT ID: NCT03397823 Completed - Clinical trials for Head and Neck Cancer

The Characterisation of RT Caries.

Start date: February 15, 2017
Phase:
Study type: Observational

Overcoming limitations of previous studies, the following research project will assess the most significant acute and long-term complications of RT that affect HNC patients: oral mucositis, dry mouth feeling, taste alteration and carious lesion incidence, all of which negatively affect cancer treatment outcomes and the quality of life of cancer survivors. This project was developed with an aim to study any possible correlations / links between the oral sequelae of RT and the negative clinical outcomes listed, in order to help the development of clinical management protocols for HNC patients to mitigate the effect on care and patient comfort and its delivery in healthcare systems. The project comprises of a longitudinal cohort study of HNC patients correlating biodata of biochemical salivary parameters, clinical outcomes and oral health status over a period up to 12 months post-RT, focusing on baseline pre-IMRT (T0), 6 months post-IMRT (T1) and up to 12 months post-IMRT treatments (T2). The ultimate goal is to identify possible predictive markers in the saliva at T0 to assist with evaluation of oral mucositis severity in individual HNC patients prior to start of treatment so that treatment can be adapted for such high-risk patients individually, to either prevent or minimise the severity of this consequence of RT.

NCT ID: NCT03378856 Recruiting - Cancer Clinical Trials

Evaluation of Technological Innovation in Radiotherapy

PERA
Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

Prospective cohort study of patients receiving standard-care radiotherapy is paramount to a better understanding of radiation effects and longterm outcomes. The primary objective is to determine the feasibility of establishing infrastructure to systematically collect clinical data, patient-reported outcomes, and imaging data from daily radiotherapy practice. Secondary objectives are to provide a control cohort for comparative effectiveness research of investigational interventions through a cmRCT design; compare imaging features with clinical outcomes; understand dose-effect relationships; quantify imaging quality metrics.