An investigation into the use of relaxation therapy as an intervention for hot flushes in women who have had breast cancer

ISRCTN ISRCTN15126436
DOI https://doi.org/10.1186/ISRCTN15126436
Secondary identifying numbers N/A
Submission date
15/10/2002
Registration date
15/10/2002
Last edited
08/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof JL Corner
Scientific

Centre for Cancer & Palliative Care Studies
ICR Centre for Cancer & Palliative Care Studies
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymRELAX
Study objectivesTo test whether relaxation can reduce the incidence and severity of menpausal hot flushes in women with breast cancer.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionWomen are randomised to:
1. Control arm: no further treatment
2. Treatment arm: relaxation method
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2000
Completion date01/01/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/2000
Date of final enrolment01/01/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Cancer & Palliative Care Studies
London
SW3 6JJ
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2008 Yes No