None listed
Conditions
Brief summary
Skin injury is a common side effect of breast-cancer radiation therapy. Radiation-induced skin toxicity is a common clinical problem that affects approximately 95% of women receiving breast radiation. Skin reactions range from redness to extensive superficial ulcers. Severe skin reactions can be painful, and may result in treatment interruptions or dose reduction, with reduced effectiveness of treatment. Over the years, there have been many trials looking at the various skin care products that are currently in use, but to date none of these have been proven to prevent radiation-induced toxicity. Recently laboratory studies have reported that use of statins (a group of cholesterol-lowering drugs) can reduce radiation-induced inflammatory reactions. They might also reduce the risk of breast cancer recurrence. We are performing this study to see if statins (in this case simvastatin) can reduce the inflammation from radiation in breast cancer patients. We will give 65 patients simvastatin 40mg daily during radiation treatment and for 3 weeks afterwards; 65 patients will get placebo (a dummy pill). A doctor will assess the skin inflammation each week during treatment and several weeks after finishing radiation and patients will also rate any symptoms and side effects.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Patients with resected invasive cancer or carcinoma in-situ of the breast treated with either breast-conserving surgery or mastectomy who are planned to receive adjuvant radiation therapy. Radiation fields may include the breast, chest wall, supraclavicular and/or axillary regions. Acceptable dose fractionation schedules include 50Gy in 25 fractions, 45Gy in 20 fractions, 42.5Gy in 16 fractions or 40Gy in 15 fractions, with or without a boost. Patients may be taking adjuvant hormonal therapy and/or trastuzumab for breast cancer Patients may have received prior adjuvant chemotherapy Patients have given written informed consent
Exclusion criteria
Patients receiving other hypofractionated radiation schedules Patients requiring the use of skin bolus with their radiotherapy Patients with pre-existing ulceration, infection or skin rashes within the radiation treatment field Known contra-indication to statins including hypersensitivity, active liver disease or unexplained persistent elevation of transaminases, concomitant administration of potent CYP3A4 inhibitors Concurrent chemotherapy Patients currently on statins or taken within the last 6 weeks Current pregnancy or breast-feeding