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Radiotherapy; Complications clinical trials

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NCT ID: NCT04149522 Terminated - Breast Cancer Clinical Trials

Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer

Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.

NCT ID: NCT03720158 Terminated - Quality of Life Clinical Trials

Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

Health-related Quality of Life (QoL) is a multidimensional construct that allows us to know the patient's perception of well-being, and how this perception is related to their illness and treatment. In clinical research, especially clinical trials, the QoL measurement has become an important element to evaluate. In patients with Head and Neck Squamous Cell Carcinoma (HNSCC), low QoL is associated with Malnutrition (MN), and Cancer Cachexia (CC) is a principal component in its multifactorial etiology. The exacerbated hypercatabolic state of CC is caused by the increase of pro-inflammatory cytokines, Reactive Oxygen Species (ROS), and other catabolic mediators. The clinical manifestation of CC is a continuous decrease in muscle mass (with or without loss of fat mass), which is not entirely reversible with nutritional support and which leads to the functional deterioration of patients. Due to CC, the patients with HNSCC who receive total enteral nutritional support have difficulties in maintaining an optimal nutritional status, and this situation is more frequent during RadioTherapy (RT). An immune-modulator nutrient, Omega-3 fatty acids (O3) have shown efficacy in improving the nutritional and inflammatory parameters of patients with HNSCC; however, little is known about their impact on patients' QoL and Functionality (Fx). Therefore, this clinical trial is proposed to provide information about the usefulness of O3 for improving the Fx and QoL of patients with HNSCC receiving total enteral nutrition during RT.

NCT ID: NCT03553212 Terminated - Clinical trials for Prostate Adenocarcinoma

Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating High Dose Radiation (HDR) Brachytherapy

THRIP
Start date: October 30, 2018
Phase: N/A
Study type: Interventional

Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps: A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients.