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ISRCTN
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ISRCTN72553848
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ClinicalTrials.gov identifier
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Public title
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Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy
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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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RMH1991
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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 study
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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 N0-1 M0)
2. Past history of radiotherapy to the breast
3. A minimum of 24 months post radiotherapy
4. No evidence of cancer recurrence
5. Palpable breast induration due to previous radiotherapy
6. Ability to attend The Royal Marsden Hospital, Sutton for assessments
7. 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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01/01/2001
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Anticipated end date
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10/10/2002
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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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IH636 grape seed proanthocyanidin extract (100 mg) or placebo TDS 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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Royal Marsden Hospital (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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Royal Marsden Hospital (UK)
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Address
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Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Date applied
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15/10/2002
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Last edited
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29/05/2008
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Date ISRCTN assigned
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15/10/2002
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