Active clinical trials for "Radiodermatitis"

The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients

Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients. The investigators would like to know also the efficacy of the device on quality of life and pain.

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..

A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care.

Breast neoplasm is the second most common type in the world. Radiation therapy is a key component in the treatment of breast cancer. Acute skin reaction is one of the most common side effects of radiation therapy. Several studies were performed for prophylaxis of this adverse event, however, until this moment there is no consensus for clinical practice . Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an agent capable of repairing damage to DNA or agents that promote cell proliferation . The low power laser promotes tissue repair ( reduces inflammatory phase and induces collagen synthesis ) . Its use in the treatment of adverse events of cancer treatment is well established in two situations : in the prophylaxis and treatment of mucositis and in the treatment of lymphedema . The purpose of this study is to use the low power laser in patients with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis.

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD). Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.

The standard treatment for early-stage breast cancer is breast-conserving surgery followed by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates with a good cosmesis and provides an effective alternative to mastectomy. However, in most women receiving radiotherapy radiation dermatitis occur to some degree. Radiation dermatitis generally manifests within a few weeks after the start of radiation therapy. Its onset varies depending on the radiation dose intensity and the normal tissue sensitivity of individuals. As the cumulative dose of radiation increases the transient erythema occurring during the first weeks of radiotherapy may evolve into the more persistent erythema and to dry or even moist desquamation that reflects the damage to the basal cell layer and the sweat and sebaceous glands. There is currently no evidence that prophylactic treatments, beyond keeping the irradiated area clean and dry, are effective in reducing the incidence or severity of radiation dermatitis (Bolderston et al. 2006). However, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide, hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In physiological conditions, the production of free radicals (Monte & Sacerdote 1994) and the action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological or caused by agents such as radiation therapy, an excess production of free radicals is observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is increased in breast cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during radiotherapy could be used to prevent the effects of free radicals and thus might protect the patient's skin from radiation-induced skin reactions. TREATMENT PLAN All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201, the other area is treated with placebo in a double-blind fashion. Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively) (see schedule of assessments, section 5.1). Study treatment is stopped if radiation dermatitis of ≥ grade 2 occurs in one or both treated areas for ≥ 3 days AND a difference in the severity of radiation dermatitis of ≥ 1 grade is seen between the two treated areas. From that point in time the patient only receives the treatment that appeared to be beneficial and this treatment is applied to the whole irradiated region until completion of the 25th, respectively 28th, fraction. Treatment stops earlier in case of progressive disease or unacceptable toxicity or intolerability.

This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

In patients undergoing adjuvant radiotherapy for breast cancer, radiation-induced skin toxicities are a common occurrence and adversely impact patients' quality of life (QOL). In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Recently, a phase III randomized trial by Herst et al. (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. Mepitel film has not been widely adopted in North America. To validate the efficacy of the film and guide the development of a larger multi-centre phase II study, a pilot study testing the efficacy of the film is proposed. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. The investigators hypothesize that the severity and incidence rates of skin reactions for patients using Mepitel film will be lower when compared to real world data from our centre, and that cosmetic outcomes will be improved with the film.