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Does the use of simvastatin reduce side effects in patients receiving radiation for breast cancer?

Randomised, controlled phase II trial of simvastatin as prophylaxis against radiation–induced skin toxicity in breast cancer patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000662864
Enrollment
81
Registered
2012-06-20
Start date
2013-01-14
Completion date
2014-07-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Simvastatin 40 mg daily orally during period of radiation treatment and for 3 weeks afterwards. The duration of radiation may vary between patients.

Sponsors

Waikato District Health Board
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026