A Phase 4 interventional study of Lemborexant 5 mg and Placebo in Postoperative Sleep Disturbance and Breast Cancer Surgery, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Treatment
Breast cancer is one of the most common malignancies among women worldwide, and surgery remains its primary treatment modality. Perioperative sleep disturbance, anxiety, depression, and acute postoperative pain are common complications in breast cancer patients. Among these, sleep disturbance is the most common and can exacerbate negative emotions and postoperative pain, delay postoperative recovery, and severely impair patients' psychological well-being and rehabilitation quality. Traditional benzodiazepine sedative-hypnotics are of limited use in the perioperative setting because of drawbacks such as drug dependence and withdrawal reactions. As a novel dual orexin receptor antagonist, lemborexant regulates sleep-wake balance, is non-addictive, and exhibits a superior safety profile. However, studies on its perioperative application in breast cancer patients remain scarce, and robust clinical evidence supporting its use is lacking. This prospective, randomized, double-blind, placebo-controlled clinical trial was designed primarily to investigate the efficacy of lemborexant in improving perioperative sleep quality in breast cancer patients, and secondarily to observe its effects on anxiety, depression, and acute postoperative pain, as well as to evaluate its safety profile. The findings of this study are expected to provide a safe and effective novel intervention strategy for the standardized perioperative management of sleep, mood, and pain in breast cancer patients, and to generate reliable evidence for optimizing enhanced recovery after surgery (ERAS) programs.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 106 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the intervention group
Drug: Lemborexant 5 mg
the control group
Drug: Placebo
The intervention group will take Lemborexant tablets three times during the perioperative period
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period
Richards-Campbell Sleep Questionnaire (RCSQ) total score
RCSQ comprises five core items evaluating distinct sleep domains: sleep depth, sleep latency, frequency of awakenings, ability to return to sleep, and overall sleep quality. Each item is scored on a 0-100 scale. The total score is calculated as the mean of the five core item scores, yielding a range from 0 to 100. A higher total score indicates better perceived sleep quality. Specifically, a score of 0 represents the worst possible sleep, while a score of 100 represents the best possible sleep.
Time frame: The first postoperative night (assessed at 8:00 on the morning of postoperative day 1)
Area under the curve (AUC) of the RCSQ total score
Area under the curve (AUC) of the RCSQ total score, calculated using the linear trapezoidal rule from RCSQ total scores obtained for the night before surgery, postoperative night 1 and postoperative night 2.
Time frame: Night before surgery, postoperative night 1 and postoperative night 2 (assessed at 08:00 on the morning of the day of surgery, postoperative day 1, and postoperative day 2)
Athens Insomnia Scale (AIS) total score
Insomnia severity will be assessed using the Athens Insomnia Scale (AIS-8), an 8-item self-report questionnaire based on ICD-10 insomnia criteria. Each item is scored on a 0-3 scale, yielding a total score of 0-24. Higher scores indicate more severe insomnia. The scale assesses sleep difficulty over the past week.
Time frame: Postoperative day 5 or discharge
Objective sleep quality
Objective sleep parameters recorded by sleep wristband, including total sleep time (TST, min) and wake after sleep onset (WASO, min), monitored during the night before surgery, postoperative night 1 and postoperative night 2.
Time frame: Night before surgery, postoperative night 1 and postoperative night 2 (20:00 to 08:00 next day)
Postoperative pain Numeric Rating Scale (NRS) score
Postoperative resting pain and pain with movement were measured using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at 24 and 48 hours postoperatively.
Time frame: 24 and 48 hours postoperatively
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), including anxiety subscale (HADS-A) and depression subscale (HADS-D). Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms.
Time frame: Baseline (before surgery) and postoperative day 2
Quality of Recovery-15 (QoR-15) total score
QoR-15 is a 15-item patient-reported outcome measure of postoperative recovery, covering pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score of 0-150, with higher scores indicating better recovery.
Time frame: Postoperative day 2
Overall medication satisfaction score
Overall medication satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Time frame: Postoperative day 2
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) total score
The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in the PSQI total score from baseline to postoperative day 30.
Time frame: Baseline and postoperative day 30
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), including anxiety subscale (HADS-A) and depression subscale (HADS-D). Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms.
Time frame: Baseline and postoperative day 30
Pain Numeric Rating Scale (NRS) score
Resting pain and pain with movement were measured using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at 24 and 48 hours postoperatively.
Time frame: Postoperative day 30
DN4-interview score
The DN4-interview consists of 7 interview items, with a total score ranging from 0 to 7. Higher scores indicate more prominent neuropathic pain features.
Time frame: Postoperative day 30
Safety and Adverse Events
Safety will be assessed by the frequency and nature of adverse events (AEs) and serious adverse events (SAEs) potentially related to the study medication. Adverse events, including but not limited to somnolence, abnormal dreams, headache, fatigue, sleep paralysis, dizziness, falls, nocturnal hypoxemia, oversedation and respiratory compromise, will be identified via daily clinical assessment and medical record review.
Time frame: From the first dose of study medication until hospital discharge or up to 7 days after the first dose, whichever occurs first.
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 110 non-industry phase 4 interventional studies under Breast Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 64. This study's planned 8 months is below that.
Counting every sponsor, half of 130 studies reached it within 42 months; a quarter within 20 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lemborexant