Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
RELAX
Study hypothesis
To test whether relaxation can reduce the incidence and severity of menpausal hot flushes in women with breast cancer.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
Women are randomised to:
1. Control arm: no further treatment
2. Treatment arm: relaxation method
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2000
Overall trial end date
01/01/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/2000
Recruitment end date
01/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Cancer & Palliative Care Studies
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18359433
Publication citations
-
Results
Fenlon DR, Corner JL, Haviland JS, A randomized controlled trial of relaxation training to reduce hot flashes in women with primary breast cancer., J Pain Symptom Manage, 2008, 35, 4, 397-405, doi: 10.1016/j.jpainsymman.2007.05.014.