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

Not Applicable

Completed

• Conditions: Breast; Cancer: Breast; Cancer

• Registration Number: ISRCTN33947463
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2003-09-01
• Study Start: 2006-09-29
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

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.

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified