ISRCTN33947463已完成未知

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

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 个研究点目标入组 50 人开始时间: 2006年9月29日最近更新: 2020年3月16日

适应症

试验速览

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•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.

•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
•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

发起方

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