ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000662864

Ethics application status

Approved

Date submitted

19/06/2012

Date registered

20/06/2012

Date last updated

20/05/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1131-9673

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Non-intervention control (patients receiving radiation but no study medication). The duration of radiation may vary between patients.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of grade 2 or greater acute radiation-related skin toxicity, assessed clinically using the modified RTOG acute skin toxicity scoring scale.

Timepoint [1]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Secondary outcome [1]

Time to onset of grade 2 or greater acute skin toxicity, assessed clinically (visually) using the modified RTOG acute radiation skin toxicity scale.

Timepoint [1]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Secondary outcome [2]

The proportion of patients requiring additional topical treatment, assessed clinically

Timepoint [2]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Secondary outcome [3]

Compliance with the trial medication, assessed clinically

Timepoint [3]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Secondary outcome [4]

Statin-related toxicities, assessed by patient questionnaire

Timepoint [4]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Secondary outcome [5]

Subjective radiation-related toxicities, assessed by patient questionnaire

Timepoint [5]

Weekly during radiation treatment and at 2 weeks and 6-12 weeks after completion of radiation.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

No

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligible, consented patients will be registered including details of three stratification factors for randomisation: surgery (breast conserving surgery vs mastectomy), planned use of boost or not, and fraction size (2.0 Gy or less vs >2.0 Gy). The completed request for randomisation will be given to the hospital pharmacy who will allocate patients to treatment based on the stratification group they fall into, in a double-blinded fashion, using numbered opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random allocation of patients in a 1:1 ratio within the strata will be undertaken via a computerised method.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2012

Actual

14/01/2013

Date of last participant enrolment

Anticipated

Actual

21/07/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

130

Accrual to date

Final

81

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Waikato Medical Research Foundation

Address [1]

Waikato Hospital
Pembroke Street
Hamilton 3240

Country [1]

New Zealand

Funding source category [2]

Hospital

Name [2]

Waikato District Health Board

Address [2]

Pembroke Street
Hamilton 3240

Country [2]

New Zealand

Primary sponsor type

Hospital

Name

Waikato District Health Board

Address

Pembroke Street
Hamilton 3240

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

C/o Ministry of Health
PO Box 1031
Hamilton 3240

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/06/2012

Approval date [1]

22/08/2012

Ethics approval number [1]

NTY/12/06/046

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Shibu Joseph

Address

Regional Cancer Centre Waikato Hospital Pembroke Street Hamilton 3240

Country

New Zealand

Phone

+64 7 839 8899

Fax

+64 7 839 8778

Email

shibu.joseph@waikatodhb.health.

Contact person for public queries

Name

Dr Shibu Joseph

Address

Regional Cancer Centre
Waikato Hospital
Pembroke Street
Hamilton 3240

Country

New Zealand

Phone

+64 7 839 8899

Fax

+64 7 839 8778

Email

shibu.joseph@waikatodhb.health.nz

Contact person for scientific queries

Name

Dr Michael Jameson

Address

Regional Cancer Centre
Waikato Hospital
Pembroke Street
Hamilton 3240

Country

New Zealand

Phone

+64 7 839 8899

Fax

+64 7 839 8778

Email

michael.jameson@waikatodhb.health.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.