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

Phase 2

Completed

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12612000662864
• Lead Sponsor: Waikato District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade 2 or greater acute radiation-related skin toxicity, assessed clinically using the modified RTOG acute skin toxicity scoring scale.[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ]

Secondary Outcome Measures

Name	Time	Method
Time to onset of grade 2 or greater acute skin toxicity, assessed clinically (visually) using the modified RTOG acute radiation skin toxicity scale.[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ];The proportion of patients requiring additional topical treatment, assessed clinically[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ];Compliance with the trial medication, assessed clinically[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ];Statin-related toxicities, assessed by patient questionnaire[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ];Subjective radiation-related toxicities, assessed by patient questionnaire[Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation. ]