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Radiodermatitis clinical trials

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NCT ID: NCT01597921 Terminated - Breast Cancer Clinical Trials

A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Start date: May 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

NCT ID: NCT01544504 Withdrawn - Radiodermatitis Clinical Trials

Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy. The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.

NCT ID: NCT01513278 Completed - Clinical trials for Radiation Induced Dermatitis

Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT01481818 Enrolling by invitation - Clinical trials for Epigallocatechin Gallate

Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Radiodermatitis and radiation mucositis were the most frequent side-effect during the course of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen species formed upon radiation therapy play a central role in initiating and driving the detrimental signaling events, antioxidant supplementation is thought to provide a photoprotective effect against radiation. Green tea extract has been shown to have antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety and efficiency of green tea extract in the treatment of radio dermatitis and radiation mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer patients receiving radiotherapy or concurrent chemoradiotherapy .

NCT ID: NCT01408407 Terminated - Rectal Neoplasms Clinical Trials

Alkagin Paste in the Prevention of Radiation Dermatitis

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.

NCT ID: NCT01367990 Terminated - Alopecia Clinical Trials

Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT). The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.

NCT ID: NCT01263366 Terminated - Radiodermatitis Clinical Trials

Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Start date: January 2011
Phase: Phase 1
Study type: Interventional

This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy. The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.

NCT ID: NCT01246973 Completed - Clinical trials for Radiation-induced Dermatitis

Oral Curcumin for Radiation Dermatitis

Start date: February 2011
Phase: Phase 2/Phase 3
Study type: Interventional

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..

NCT ID: NCT01228565 Completed - Clinical trials for Head and Neck Carcinoma

Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

GORTEC 2009-01
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.

NCT ID: NCT01042938 Completed - Breast Cancer Clinical Trials

Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients

Start date: January 2008
Phase: Phase 2
Study type: Interventional

Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.