Investigating the effectiveness of esketamine in reducing depression for breast cancer patients after surgery
| ISRCTN | ISRCTN12578022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12578022 |
- Submission date
- 20/08/2024
- Registration date
- 25/08/2024
- Last edited
- 22/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is one of the most common cancers among women worldwide, and while treatments can be effective, they often come with significant side effects. One of the most challenging side effects is depression, which can greatly affect patients' quality of life. Traditional antidepressants, though helpful, often take a long time to work and may cause unwanted side effects. To address this, researchers are exploring new treatment options. Esketamine, a medication that has recently shown promise, can improve mood quickly, making it a potentially valuable option for treating depression after breast cancer surgery. This study aims to investigate how effective Esketamine is in treating depression in breast cancer patients after surgery.
Who can participate?
Women who have undergone breast cancer surgery (specifically, a modified radical mastectomy) at the Cancer Hospital, Chinese Academy of Medical Sciences. The participants must have been treated at this hospital between July 2020 and March 2023.
What does the study involve?
Participants in the study will first have their depression levels assessed using a standard scale (Hamilton Depression Scale, HAMD-17) before their surgery. They will then be randomly assigned to one of two groups: one group will receive an injection of Esketamine, and the other group will receive a placebo (a substance with no active medication). Six months after surgery, the participants' depression levels will be reassessed through follow-ups conducted via the WeChat app.
What are the possible benefits and risks of participating?
The potential benefit for participants is the possibility of experiencing faster relief from depression if they receive Esketamine. However, as with any medication, there are risks of side effects, and the effectiveness of Esketamine specifically for this purpose is still being studied. Participants in the placebo group may not experience the same benefits, but their involvement is crucial to understanding whether Esketamine is genuinely effective.
Where is the study run from?
The study is being conducted at the First Affiliated Hospital of the University of South China, with follow-ups performed remotely using WeChat.
When is the study starting and how long is it expected to run for?
March 2020 to October 2023.
Who is funding the study?
The study is funded by several organizations, including the Natural Science Foundation of Hunan Province, the Wu Jieping Medical Foundation Clinical Research Special Fund, the NewRay Oncology Supportive Care Research Project, and the China Postdoctoral Science Foundation (China)
Who is the main contact?
Dr Haifan Xu, 3287917718@qq.com
2571514621@qq.com
Contact information
Public
4-2-1205,languiyuan,chuanshan road
Hengyang
421001
China
 ORCID ID |
0009-0001-2437-4555 |
|---|---|
| Phone | +86 15932910750 |
| 3287917718@qq.com |
Scientific, Principal Investigator
4-2-1205,languiyuan,chuanshan road
Hengyang
421001
China
| Phone | +86 15932910750 |
|---|---|
| 2571514621@qq.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Internet/virtual |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized, double-blind, controlled trial to evaluate the effect of esketamine on postoperative depressive symptoms in breast cancer patients undergoing modified radical mastectomy (Esketamine in Breast Cancer-Depression Randomized Trial) |
| Study acronym | EBC-DRT |
| Study objectives | Esketamine can effectively reduce postoperative depressive symptoms in breast cancer patients undergoing modified radical mastectomy, with significant differences compared to the placebo group. |
| Ethics approval(s) |
Approved 25/12/2019, Ethics Committee of The First Affiliated Hospital of University of South China (69 Chuanshan Road, Shigu District, Hengyang, 421001, China; +44 734-8279018; nhfyllwyh@163.com), ref: No. 2020LL0304001 |
| Health condition(s) or problem(s) studied | Breast cancer with postoperative depressive symptoms |
| Intervention | This randomized, double-blind, controlled trial enrolled 108 breast cancer patients who underwent modified radical mastectomy between July 2020 and March 2023. All patients were assessed with the Hamilton Depression Scale (HAMD-17) prior to surgery. The trial collected patient demographics, including age, weight, height, and pathology type. The pathology type of all patients was confirmed by the hospital's pathology department to ensure data accuracy. A detailed treatment history of each patient, including type of surgery, chemotherapy, and radiotherapy, was meticulously recorded to ensure data completeness. The treatment history of all patients was provided by the treating physicians and subsequently cross-checked by study team members. Patients were consecutively recruited during the study period and randomly assigned to groups based on whether they received esketamine treatment. Esketamine injection (purchased from Jiangsu Hengrui Pharmaceutical Co., Ltd, Product No. KH080601) was administered to the experimental group (Group E), while the control group (Group C) received a placebo . Additionally, patients were diagnosed using imaging and histological methods. The HAMD-17 scores for all patients were reassessed at 6 months postoperatively through WeChat-based follow-up. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Esketamine |
| Primary outcome measure | Hamilton Depression Scale (HAMD-17) scores at baseline and 6 months postoperatively |
| Secondary outcome measures | 1. HAMD-17 score changes at baseline (pre-surgery) and 6 months post-surgery 2. Patient demographic data (age, weight, height, pathology type)measured by review of patient medical records at the time of enrollment |
| Overall study start date | 01/03/2020 |
| Completion date | 01/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 123 |
| Total final enrolment | 108 |
| Key inclusion criteria | 1. HAMD-17 score between 8 and 24 (mild to severe depressive symptoms) 2. Age range between 18 and 65 years 3. American Society of Anesthesiologists (ASA) physical status classification of I-II 4. Confirmed diagnosis of breast cancer and planned unilateral radical mastectomy for breast cancer |
| Key exclusion criteria | 1. HAMD-17 score of greater than 24 or less than 7 2. Other psychiatric disorders (e.g., schizophrenia and bipolar disorder) 3. History of psychiatric disorders prior to the study 4. Patients who have used psychotropic medications or have other serious systemic illnesses (including serious heart, kidney, or liver disease) 5. Contraindication or allergy to the use of esketamine 6. Planned surgery other than radical mastectomy alone (e.g., reconstruction) |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Hengyang
421001
China
Sponsor information
Hospital/treatment centre
69 Chuanshan Road, Shigu District, Hengyang City, Hunan Province
Hengyang
421001
China
| Phone | +86 734-8578566 |
|---|---|
| nhdxfsdy11@163.com | |
| Website | https://www.nhfyyy.com |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 12/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysedduring the current study will be available uponrequest from (Haifan Xu;3287917718@qq.com) |
Editorial Notes
21/08/2024: Trial's existence confirmed by Ethics Committee of The First Affiliated Hospital of University of South China.
