Self-help cognitive behavioural therapy for hot flushes and night sweats during androgen deprivation therapy for prostate cancer: the MANCAN2 randomized controlled trial.

BACKGROUND

Androgen deprivation therapy (ADT) causes hot flushes and night sweats (HFNS) and is associated with sleep disturbance, anxiety, low mood and cognitive impairment. We tested self-help cognitive behavioural therapy (CBT), when guided by prostate cancer nurse specialist teams, for mitigation of the long-term impact of HFNS, and associated symptoms.

METHODS

Prostate cancer patients receiving ADT, with a HFNS Problem Rating Scale ≥2, were randomised (1:1) to treatment as usual (TAU) or CBT + TAU, stratified by centre and treatment intent. CBT was a 4-week self-help intervention with pre- and post-intervention group workshops guided by trained prostate cancer nurse specialists.

PRIMARY ENDPOINT: 6-month HFNS Problem Rating Scale. Secondary endpoints included HFNS frequency, ADT compliance and rating scales for HFNS beliefs and behaviours, quality of life, anxiety, depression and sleep.

RESULTS

162 patients were randomised. 6 month mean HFNS Problem Rating Scale score was not significantly different between the TAU and CBT + TAU groups (mean 4.08 vs 4.04, 95% confidence interval (CI) for difference: -0.89, 0.80; p = 0.97), although was improved at 6 weeks (mean 4.47 vs 3.79, 95% CI: -1.26, -0.09; p = 0.03), when depression, anxiety scores and ADT compliance also favoured CBT + TAU.

CONCLUSIONS

The addition of CBT in prostate cancer patients receiving ADT improved short-term HFNS severity, in addition to improved anxiety and depression scores, but these were not maintained at 6 months.

CLINICAL TRIAL REGISTRATION: ISRCTN58720120.