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ISRCTN
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ISRCTN15126436
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ClinicalTrials.gov identifier
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Public title
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An investigation into the use of relaxation therapy as an intervention for hot flushes in women who have had breast cancer
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Scientific title
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Acronym
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RELAX
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Serial number at source
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N/A
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Study hypothesis
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To test whether relaxation can reduce the incidence and severity of menpausal hot flushes in women with breast cancer.
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Lay summary
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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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Randomised controlled 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 cancer
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Participants - inclusion criteria
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Patients should:
1. Meet the national HRT study entry criteria
2. Women diagnosed with stage I/II breast cancer with no evidence of recurrence
3. Be postmenopausal (amenorrhoea for >6 months or surgical or radiation ovarian ablation)
4. Be experiencing menopausal hot flushes
5. Able to attend hospital for extra visits
6. Able to complete written records in English
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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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01/12/2000
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Anticipated end date
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01/01/2001
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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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Women are randomised to:
1. Control arm: no further treatment
2. Treatment arm: relaxation method
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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 (CRUK) (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18359433
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Contact name
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Prof
JL
Corner
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Address
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Centre for Cancer & Palliative Care Studies
ICR Centre for Cancer & Palliative Care Studies
Fulham Road
Chelsea
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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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)207 317 5186
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Fax
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+44 (0)207 487 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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15/10/2002
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Last edited
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21/12/2011
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Date ISRCTN assigned
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15/10/2002
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