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ISRCTN
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ISRCTN45257322
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ClinicalTrials.gov identifier
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Public title
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Double-blind, placebo controlled randomised trial of alpha-tocopherol and oxpentifylline in patients with radiation fibrosis
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Scientific title
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Acronym
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N/A
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Serial number at source
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SP2313/0201
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Double-blind, placebo controlled randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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1. Past history of early breast cancer (T1-3 N0 M0)
2. No axillary surgery or lower axillary sampling only
3. Radiotherapy to the breast/chest wall plus axilla and or stem cell factor (SCF)
4. A minimum of 5 years post-radiotherapy
5. No evidence of cancer recurrence
6. Disabilities due to previous radiotherapy
7. Ability to attend RMT Sutton for assessments
8. Written informed consent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1996
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Anticipated end date
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31/12/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. DL-Alpha Tocopheryl Acetate 500 mg (or placebo) po BD for 6 months
2. Oxpentifylline 400 mg (or placebo) po BD for 6 months
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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22/05/2008
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Date ISRCTN assigned
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01/07/2001
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