Using low doses of esketamine to improve sleep quality after breast cancer surgery
Effect of Subanesthetic Dose of Esketamine on Sleep Quality in Patients With Breast Cancer After Chemotherapy
This study is testing whether low doses of esketamine can help improve sleep quality for people recovering from breast cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06773143 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of subanesthetic doses of esketamine on sleep quality in patients undergoing modified radical mastectomy for breast cancer. A total of 184 participants will be enrolled, and their sleep quality will be assessed using various scales before and after surgery. The study aims to understand how esketamine can mitigate postoperative sleep disturbances, which are common in patients undergoing surgery after neoadjuvant chemotherapy. Blood samples will also be collected to analyze potential biomarkers related to sleep and inflammation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with a diagnosis of breast cancer who are receiving neoadjuvant chemotherapy.
Not a fit: Patients with a BMI over 30, cognitive dysfunction, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and recovery outcomes for breast cancer patients undergoing surgery.
How similar studies have performed: While the use of esketamine for sleep disturbances is a novel approach, similar studies have shown promising results in managing postoperative pain and anxiety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with breast cancer by pathology and immunohistochemistry 2. Patients receiving neoadjuvant chemotherapy 3. Age 18 to 65 years old; d) ; 4. ASA grade Ⅰ - Ⅲ 5. BMI 18 to 30 kg/m2 Exclusion Criteria: * 1: Patients refuse to participate in the study 2: BMI \> 30 kg/m2 3: Recent history of drug abuse 4: Allergy to or contraindications to esketamine 5: Cognitive dysfunction or inability to communicate 6: Severe dysfunction of important organs such as liver and kidney function
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: wenwen zhang, Dr
- Email: 1395626955@qq.com
- Phone: +8615366110306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.