The postoperative pain management of stereotactic radiosurgery in patients with brain metastases from lung cancer
| ISRCTN | ISRCTN68431074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68431074 |
- Submission date
- 12/02/2025
- Registration date
- 07/03/2025
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The mechanism of postoperative pain after stereotactic radiosurgery (SRS) for lung cancer brain metastases is complex and involves a variety of factors and pathways, including direct compression of the tumour to stimulate the nerves, bone metastasis of the lesion, secretion of tumour factors to induce pain, and other parts of the patient will also suffer from pain due to psychological and mental factors. This study aims to investigate the clinical effect of the combination of morphine sulfate sustained-release tablets and Banxia Baizhu Tianma Decoction in the postoperative pain management of SRS in patients with brain metastases from lung cancer.
Who can participate?
Patients with brain metastases from lung cancer.
What does the study involve?
Participants were randomly grouped. The control group was treated with morphine sulfate sustained-release tablets for analgesia after SRS, and the research group was treated with morphine sulfate sustained-release tablets and Banxia Baizhu Tianma Decoction after SRS.
What are the possible benefits and risks of participating?
The results of this study will demonstrate the clinical effect of the combination of morphine sulfate sustained-release tablets and Banxia Baizhu Tianma Decoction in the postoperative pain management of SRS in patients with brain metastases from lung cancer.
Where is the study run from?
Hebei Provincial Traditional Chinese Medicine Hospital (China)
When is the study starting and how long is it expected to run for?
January 2021 to July 2024
Who is funding the study?
Hebei Provincial Traditional Chinese Medicine Hospital (China)
Who is the main contact?
Li Yang, yangli_hbzyy@163.com
Contact information
Public, Scientific, Principal Investigator
No. 389 of Zhongshan East Road
Shijiazhuang
050000
China
| Phone | +86 (0)311-69095581 |
|---|---|
| yangli_hbzyy@163.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Clinical effects of the combination of morphine sulphate sustained-release tablets and Banxia Baizhu Tianma Decoction in the postoperative pain management of stereotactic radiosurgery in patients with brain metastases from lung cancer |
| Study objectives | To investigate the clinical effect of the combination of morphine sulfate sustained-release tablets and Banxia Baizhu Tianma Decoction in the postoperative pain management of stereotactic radiosurgery (SRS) in patients with brain metastases from lung cancer. |
| Ethics approval(s) |
Approved 20/05/2024, Hebei Provincial Traditional Chinese Medicine Hospital (No. 389 of Zhongshan East Road, Shijiazhuang, 050000, China; +86 (0)311-69095316; hbzylczyx@163.com), ref: Not applicable |
| Health condition(s) or problem(s) studied | Postoperative pain management of SRS in patients with brain metastases from lung cancer |
| Intervention | A total of 269 patients with brain metastasis of lung cancer admitted to the hospital from January 2021 to July 2024 were selected as the study subjects by convenience sampling method. They were randomly grouped according to the numerical sampling method. The control group (134 cases) was treated with morphine sulfate sustained-release tablets for analgesia after SRS, and the research group (135 cases) was treated with morphine sulfate sustained-release tablets and Banxia Baizhu Tianma Decoction after SRS. Both groups of patients used conventional interventions for intermediate and advanced cancer, such as dietary interventions, exercise regulation, lifestyle correction and so on. On this basis, patients in the control group used morphine sulfate sustained-release tablets (Menti [China] Pharmaceutical Co Ltd, specification: 30 mg/tablet, State Pharmaceutical Licence H10980062) for analgesic intervention, and the applied dosage was 1 tablet/times, 2 times/day. Patients in the research group were combined with Banxia Baizhu Tianma Decoction for analgesic treatment on the basis of the control group. Banxia Baizhu Tianma Decoction: 12 g of Pinellia ternata, 10 g of Gastrodia elata blume, 12 g of Poria cocos, 8 g of Red tangerine peel, 12 g of Largehead Atractylodes Rh, 6 g of Liquorice root, 2 slices of Ginger, and 3 jujubes. 1 dose per day, 400 mL of water decoction, 1 time in the morning and 1 time in the evening. Both groups of patients were treated for 2 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine sulfate sustained-release tablets; Banxia Baizhu Tianma Decoction |
| Primary outcome measure | The following primary outcome measures were assessed at 2 weeks after the intervention: 1. The analgesic effect after intervention was divided into complete relief (CR, patients‘ pain was completely relieved after medication), partial relief (PR, patients’ pain was relieved after intervention and normal sleep was not affected), minor relief (MR, pain was improved after analgesia but it was not obvious, and patients' life and sleep were affected), and no relief (NR, analgesia was ineffective); the total effective rate = (CR+PR)/total number of cases × 100%. 2. The incidence of adverse reactions in the process of analgesia between the two groups of patients, mainly including constipation, nausea and vomiting, drowsiness, urine retention and so on 3. Quality of life assessed using the Quality of Life Scale for Oncology Patients |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2021 |
| Completion date | 31/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 269 |
| Total final enrolment | 269 |
| Key inclusion criteria | 1. Diagnosed with brain metastasis of lung cancer with clear pathological results and a score of ≥4 on the Pain Level Assessment Scale 2. Clear consciousness to cooperate with the assessment of pain level and quality of life 3. No allergy to the study drugs |
| Key exclusion criteria | 1. Allergic to the study drug 2. Drug addicts 3. Alcohol addicts 4. Respiratory depression 5. Psychiatric history |
| Date of first enrolment | 01/01/2021 |
| Date of final enrolment | 31/07/2024 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Hospital/treatment centre
No. 389 of Zhongshan East Road
Shijiazhuang
050000
China
| Phone | +86 (0)311-69095502 |
|---|---|
| hbzylczyx@163.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 analysed during the current study will be available upon request - further details to be added at a later date |
Editorial Notes
13/02/2025: Study's existence confirmed by Hebei Provincial Traditional Chinese Medicine Hospital.
