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
Secondary identifying numbers	N0013145883

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

Clinical Oncology
Ground Floor, Lambeth Wing
St Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 4205
Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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.
Secondary outcome measures	Sustained effect passed 4 months as a secondary end-point.
Overall study start date	01/09/2002
Completion date	01/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	50 subjects
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

England
United Kingdom

Study participating centre

Clinical Oncology

London
SE1 7EH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK) Own Account

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

27/02/2020: No publications found. All search options exhausted.