Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/08/2012
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

Mrs Gillian McCall

ORCID ID

Contact details

Clinical Oncology
Ground Floor
Lambeth Wing
St Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 4205

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013145883

Study information

Scientific title

Acronym

Study hypothesis

Is hypnosis an effective treatment for vasomotor symptoms of the menopause in women with early stage breast cancer?

Ethics approval

Added 23/03/10: approved by St Thomas’ Hospital LREC.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2002

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

50 subjects

Participant 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

Recruitment start date

01/09/2002

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Oncology
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes