Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
08/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof JL Corner

ORCID ID

Contact details

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

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 measures

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

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

http://www.cancer.org.uk

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

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18359433

Publication citations

  1. 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.

Additional files

Editorial Notes