title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  This study supports the use of the CPPT as an aid to reduce sleep disturbance and the frequency/severity of hot flushes.
authors.affiliation: Nursing & Health Care School, University of Glasgow, 59 Oakfield Avenue, Glasgow, G12 8LL, UK. Rebecca.Marshall-McKenna@ggc.scot.nhs.uk.
authors.forename: R
authors.initials: R
authors.lastname: Marshall-McKenna
authors.affiliation: The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: A
authors.initials: A
authors.lastname: Morrison
authors.affiliation: The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: L
authors.initials: L
authors.lastname: Stirling
authors.affiliation: The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hutchison
authors.affiliation: Nursing & Health Care School, University of Glasgow, 59 Oakfield Avenue, Glasgow, G12 8LL, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Rice
authors.affiliation: The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: Nursing & Health Care School, University of Glasgow, 59 Oakfield Avenue, Glasgow, G12 8LL, UK.
authors.forename: L
authors.initials: L
authors.lastname: Paul
authors.affiliation: CRUK CTU Glasgow, Institute of Cancer Sciences, The Beatson West of Scotland Cancer Centre, University of Glasgow, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: M
authors.initials: M
authors.lastname: Rodger
authors.affiliation: The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: I R
authors.initials: IR
authors.lastname: Macpherson
authors.affiliation: CRUK CTU Glasgow, Institute of Cancer Sciences, The Beatson West of Scotland Cancer Centre, University of Glasgow, 1053 Great Western Road, Glasgow, G12 0YN, UK.
authors.forename: E
authors.initials: E
authors.lastname: McCartney
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects; D001007:Anxiety; D001512:Bedding and Linens; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000523:psychology; D017679:Cryotherapy / Q000295:instrumentation* / Q000379:methods; D003863:Depression; D005260:Female; D019584:Hot Flashes / Q000139:chemically induced / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced / Q000523:psychology / Q000628:therapy*; D011795:Surveys and Questionnaires; D013546:Sweating; D013629:Tamoxifen / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen
keywords: Breast cancer; Cooling pad pillow topper; Endocrine therapy; Hot flushes; Self-management; Sleep disturbance