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 |
| Protocol serial number | N/A |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- 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
Scientific
Centre for Cancer & Palliative Care Studies
ICR Centre for Cancer & Palliative Care Studies
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | RELAX |
| Study objectives | To 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) studied | Breast cancer |
| Intervention | Women are randomised to: 1. Control arm: no further treatment 2. Treatment arm: relaxation method |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2000 |
| Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Cancer & Palliative Care Studies
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2008 | Yes | No |
