A randomised trial of the use of hypnosis to affect menopausal vasomotor symptoms in women with early stage breast cancer, using a waiting list control
| ISRCTN | ISRCTN33947463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33947463 |
| Protocol serial number | N0013145883 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK) Own Account |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 27/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Gillian McCall
Scientific
Scientific
Clinical Oncology
Ground Floor, Lambeth Wing
St Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 4205 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial of the use of hypnosis to affect menopausal vasomotor symptoms in women with early stage breast cancer, using a waiting list control |
| Study objectives | Is hypnosis an effective treatment for vasomotor symptoms of the menopause in women with early stage breast cancer? |
| Ethics approval(s) | Added 23/03/10: approved by St Thomas Hospital LREC. |
| Health condition(s) or problem(s) studied | Cancer: Breast |
| Intervention | Randomised trial with waiting list control: patients complaining of vasomotor symptoms of hot flushes/ night sweats have 3 sessions of hypnosis over 3 weeks. Control arm: similar treatment but delayed for 3 weeks. Both groups to keep diaries of vasomotor events and complete QOL questionnaires at strategic points through a 16-week period. On-going follow-up where possible. |
| Intervention type | Other |
| Primary outcome measure(s) |
Reduction in frequency or intensity of flushing compared with waiting list control. Treatment effects and improvements will be maintained for over 3 months for the combined group. |
| Key secondary outcome measure(s) |
Sustained effect passed 4 months as a secondary end-point. |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 50 |
| Key inclusion criteria | Women who suffer from vasomotor symptoms of menopause who fit the criteria for the national HRT & Breast Cancer Trial and who are randomised to non-hormonal intervention; or women who fit the criteria who are not in the HRT Trial at all. Inclusion criteria: 1. Have had proven stage I/II breast cancer with no clinical evidence of recurrence (ER status where available will be documented but not used as an inclusion or exclusion criteria). 2. Have either: been amenorrhoeic for 36 months (including women who have had radiation or chemical induced ovarian suppression) irrespective of menopausal status at time of diagnosis or have had a surgical bilateral oophorectomy and are therefore eligible at any time after surgery. 3. Are experiencing vasomotor symptoms (i.e. hot flushes or night sweats) with or without vaginal dryness. 4. Have signed the informed consent form, including willingness to co-operate in assigned treatment and follow up. All women who do not fall into the categories detailed in the ineligibility section below, will be eligible irrespective of current/previous treatment for breast cancer. |
| Key exclusion criteria | 1. Are currently taking HRT, or have received oral or transdermal HRT within the last three months, or have received an HRT implant within the last 5 years 2. Are currently receiving chemotherapy, due to a theoretical increase in risk of venous thromboembolic disease (Pritchard et al 1996) 3. Are receiving GnRHa eg Zoladex, with less than 2 years treatment remaining. The amenorrhoeic state induced by Zoladex is completely reversible. Therefore, patients with less than 2 years treatment remaining would not eligible for the full 2 year term of the intended HRT treatment 4. Are pregnant or have: 5. DCIS or LCIS alone 6. Recurrent breast cancer 7. Concomitant or previous other malignancy except non-melanoma skin cancer or in situ cancer of the cervix. 8. Undiagnosed post-menopausal bleeding 9. Severe, active liver disease with abnormal liver function tests 10. A history of alcohol, drug or chemical abuse 11. A history of DVT/PE or retinal vein thrombosis - patients with abnormal fibrinolysis or coagulation must be excluded. Patients with either thrombophlebitis or superficial phlebitis alone can be included 12. Acute, intermittent porphyria |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Oncology
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/02/2020: No publications found. All search options exhausted.
