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 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 trial start date
01/09/2002
Overall trial end date
01/09/2003
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list