A randomized, placebo-controlled trial of melatonin on breast cancer survivors: impact on sleep, mood, and hot flashes

Abstract

Purpose To examine the effects of melatonin supplementation on sleep, mood, and hot flashes in postmenopausal breast cancer survivors. Methods In a randomized, double-blind, placebo-controlled study, 95 postmenopausal women with a prior history of stage 0-III breast cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 3 mg oral melatonin (n=48) or placebo daily (n=47) for 4 months. Sleep, mood, and hot flashes were assessed at baseline and four months via self-administered questionnaire using the Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiologic Studies – Depression (CES-D), and the North Central Cancer Treatment Group (NCCTG) hot flash diary, respectively. Results Eighty-six women (91%) completed the study and provided pre and post questionnaires. At baseline, 52% of participants reported poor sleep in the month prior to enrollment. Compared to subjects on placebo, subjects randomized to melatonin experienced significantly greater improvements in subjective sleep quality as measured by the PSQI, including domains on sleep quality, daytime dysfunction and total score. For example, the mean change in PSQI score was −0.1 in the placebo group compared to −1.9 in the melatonin group (p<0.001). There were no significant differences in measures of depression or hot flashes. Conclusions Sleep disturbances are common among breast cancer survivors, even after completion of active cancer treatment. This is the first randomized placebo-controlled study among breast cancer survivors to demonstrate that melatonin was associated with an improvement in subjective sleep quality, without any significant adverse effects.

Sleep Quality in Women with Breast Cancer: An Integrative Review

“…tance of longitudinal studies because analyzing the patient in 2 or more stages of treatment and documenting the difference in quality of sleep, may be helpful to nurses in managing their patients care. Nine articles reported randomized clinical trials [8,10,[16][17][18][19][20][21]] and 3 were a secondary analysis [4,[22][23].…”

“…Because the sleep disturbances are common among breast cancer survivors, even after completion of active cancer treatment [10].…”

Melatonin-Induced Oncostasis, Mechanisms and Clinical Relevance

“…In another study, 95 postmenopausal women with a prior history of stage 0-III breast cancer and who had completed active cancer treatment, 3 mg of melatonin or placebo was used for 4 months. Subjects receiving melatonin experienced significantly greater improvements in subjective sleep quality but there were no significant differences in measures of depression or hot flashes, presumably because of the low amounts of melatonin used [171] ( Table 2). …”

“…However, they generally remained underdiagnosed and poorly treated [170][171][172][173]. In a cross-sectional survey study on nearly 1,000 cancer patients to examine the prevalence of sleep problems, sleep disturbance was most prevalent among the lung and breast cancer patients.…”

Variação longitudinal da qualidade do sono em mulheres com câncer de mama

“…(6) Depression and mood swings may present throughout treatment or even after its conclusion. (7,8) Depressive symptoms are predictors of subjective sleep quality in women with breast cancer before, during and after radiation therapy. (9) Other authors have found that women with early-stage breast cancer when compared with a control group including women without breast cancer, showed a worsening in sleep quality, higher depressive symptoms, more fatigue, and lesser quality of life, one year after chemotherapy.…”