A randomised trial of the cool pad pillow topper versus standard care for sleep disturbance and hot flushes in women on endocrine therapy for breast cancer

Marshall-Mckenna, R. , Morrison, A., Stirling, L., Hutchison, C., Rice, A.M., Hewitt, C., Paul, L., Rodger, M., MacPherson, I. and McCartney, E. (2016) A randomised trial of the cool pad pillow topper versus standard care for sleep disturbance and hot flushes in women on endocrine therapy for breast cancer. Supportive Care in Cancer, 24(4), pp. 1821-1829. (doi: 10.1007/s00520-015-2967-3) (PMID:26446702)

Abstract

Purpose: Quality of life in women receiving adjuvant endocrine therapy for breast cancer (BC) may be impaired by hot flushes and night sweats. The cool pad pillow topper (CPPT) is a commercial product, promoted to improve quality of sleep disrupted by hot flushes. This study aimed to identify if the CPPT reduces severity of sleep disturbance by minimising effects of hot flushes. Methods: This randomised phase II trial, recruited women with BC, on adjuvant endocrine therapy, experiencing hot flushes and insomnia. Participants were randomised (stratified by baseline sleep efficiency score (SES) and menopausal status) to the intervention arm (CPPT + standard care) or control arm (standard care). Participants completed Hospital Anxiety and Depression Scale and Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires and fortnightly sleep/hot flush diaries (where responses were averaged over 2-week periods). The primary endpoint was change in average SES from −2 to 0 weeks to 2 to 4 weeks. Results: Seventy-four pre- (68.9 %) and post-menopausal (31.1 %) women were recruited. Median age was 49.5 years. Endocrine therapies included tamoxifen (93.2 %). Median SES at weeks 2 to 4 improved in both arms but the increase on the intervention arm was almost twice that on the control arm (p = 0.024). There were significantly greater reductions in hot flushes and HADS depression in the intervention arm (p = 0.09 and p = 0.036, respectively). There were no significant differences in FACT-B or HADS anxiety. Conclusion: This study supports the use of the CPPT as an aid to reduce sleep disturbance and the frequency/severity of hot flushes.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McCartney, Miss Elaine and Morrison, Dr Audrey and Marshall-Mckenna, Dr Rebecca and Rice, Prof Ann Marie and MacPherson, Professor Iain and Hutchison, Dr Catherine and Paul, Dr Lorna and Rodger, Ms Michaela
• Authors: Marshall-Mckenna, R., Morrison, A., Stirling, L., Hutchison, C., Rice, A.M., Hewitt, C., Paul, L., Rodger, M., MacPherson, I., and McCartney, E.
• Subjects: R Medicine > R Medicine (General); R Medicine > RT Nursing
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Nursing and Health Care
• Journal Name: Supportive Care in Cancer
• Publisher: Springer Berlin Heidelberg
• ISSN: 0941-4355
• ISSN (Online): 1433-7339
• Published Online: 08 October 2015