View clinical trials related to Radiodermatitis.
Filter by:Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the major side effect affected quality of life. Radiation dermatitis can be divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment, and may cause treatment interruption and affect the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality of life of breast cancer patients after treatment. This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect. Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical examinations, questionnaire surveys, skin observation and measurements, and photographs. The total study time is at least 3 months. The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate. The skin physiological parameters will be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer. Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.
The treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. These treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. Improving the quality of life of patients is today a therapeutic challenge. The objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.
This is a Randomized Controlled Clinical Trial Women with breast cancer who are indicated for treatment with adjuvant radiotherapy will be eligible. Patients who underwent surgery and/or chemotherapy outside the institution and patients with comprehension difficulties will be excluded. After recruitment, women will be allocated into two groups: intervention (use of LED board) and control (placebo board). The degree of radiodermatitis, pain, edema and/or lymphedema, paresthesia, functionality, quality of life, skin conditions and related independent variables, such as the characteristics of the patient, the tumor and the oncological treatment performed will be evaluated. Thus, the hypothesis of the study is the prevention of radiodermatitis, which is a complication of radiotherapy treatment using photobiomodulation with LED board as a means of intervention.
This study was a single-center prospective phase I clinical study to evaluate the effectiveness and safety of BH4 in the treatment of radiation-induced skin injury during vulvar cancer radiotherapy.
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.
Radiation-induced dermatitis is the most common complication of radiotherapy for cancer treatment. However, there is no satisfactory management to deal with the problem. Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin diseases but lack of evidence to support efficacy. The aim of this trial is to evaluate the effectiveness of Ru-Yi-Jin-Huang Powder for radiation-induced dermatitis.
The aim is to quantify the efficiency of the Safetac product Mepitel® Film on the prevention of radiodermatitis for cancer patients treated with external beam radiation therapy near the inguinal fold(s). Previous studies have looked into the differences in skin reactions for Mepitel® Film versus hydro-active colloid gel in breast cancer [1, 2] and head and neck cancer [3]. In breast cancer, the prevalence of radiation induced dermatitis has strongly decreased due to of modern radiotherapy techniques and fractionation. In the groin, however, this is not the case, and radiation dermatitis remains an important problem. To the best of our knowledge, no previous study has looked into the efficiency of a prophylactic Mepitel® Film protocol in the inguinal fold. The goal of this study is to evaluate whether the Mepitel® Film offers a lower degree of radiation-induced dermatitis compared to hydro-active colloid gel and thereby challenging the gold standard. References: 1. Herst, P., Bennett, N., Sutherland, A., Peszynski, R., Paterson, D. and Jasperse, M. (2014). Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiotherapy and Oncology, 110(1), pp.137-143. 2. Møller, P., Olling, K., Berg, M., Habæk, I., Haislund, B., Iversen, A., Ewertz, M., Lorenzen, E. and Brink, C. (2018). Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - A Danish intra-patient randomized multicentre study. Technical Innovations & Patient Support in Radiation Oncology, 7, pp.20-25. 3. Wooding, H., Yan, J., Yuan, L., Chyou, T., Gao, S., Ward, I. and Herst, P. (2018). The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. The British Journal of Radiology, 91(1081), p.20170298.
Fenofibrate is a specific ligand for PPARα, which has been used for the treatment of hypercholesterolemia, hypertriglyceridemia, diabetes and cardiovascular diseases for long time. Fenofibrate reduces low-density lipoprotein (LDL), very low density lipoprotein (VLDL) and triglyceride levels, while increases high-density lipoprotein (HDL) levels. PPARα has also shown antioxidant and anti-inflammatory properties. Fenofibrate confers cytoprotective effect against myocardial ischemia-reperfusion (I/R) injury in rats by suppressing cell apoptosis and ameliorates age-related renal injury through the activation of AMPK and SIRT1 signaling. However, the safety and effectiveness of fenofibrate on the progression of radiation-induced skin injury remain unknown. The purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.
Clinical significance and current evidence: Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment. Current literature does not conclusively support the use of one agent over another for prevention of radiation dermatitis. The choice of agents used in clinical practice is highly variable, with aqueous agents being one of the commonest. Specific Aims: The aim of this study is to evaluate if the investigational product (StrataXRT), a silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma. Trial Design: The study will be conducted using a prospective, double-blind randomized control trial in 2 institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and the primary endpoint is reached when grade 2 or higher dermatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary objectives will be evaluation of the time to onset of dermatitis, the time to complete recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be done at baseline, weekly during treatment, 1 week post treatment and unless the skin has resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end of follow-up. The safety end-point is reached when grade 4 dermatitis occurs. Hypothesis and statistics: The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients in total. The study duration is estimated to be 2 years.
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, radiation dermatitis is still common. It has an impact on pain and quality of life, and if severe, may lead to interruption of the radiation schedule for the patient. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2 radiation dermatitis is developed, trolamine is not allowed to use any more. Medical Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment of radiation dermatitis. It could be used during the course of radiotherapy, even when grade ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients with NPC, compared with trolamine.