Cancer-Related Insomnia
Conditions
Interventions
Traditional Chinese Medicine (TCM) Group:Taking sedative-hypnotic medication combined with the Modified Baihe Dihuang Decoction
Traditional Chinese Medicine Combined with Press Needle Group:Taking sedative-hypnotic medication combined with the Modified Baihe Dihuang Decoction and press needles
Control Group:The control group will continue the original anti-tumor treatment regimen and maintain the treatment (supportive and symptomatic treatment) as well as the sedative-hypnotic medications t
Sponsors
Yue Yang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and = 80 years; male or female. 2. Patients with a pathologically confirmed diagnosis of a malignant tumor. 3. Meet the diagnostic criteria for insomnia (or "bu mei" in TCM) according to both Western medicine and Traditional Chinese Medicine, and meet the diagnostic criteria for Yin-deficiency syndrome. 4. A cumulative score > 7 on the Pittsburgh Sleep Quality Index (PSQI). 5. Have been taking sedative-hypnotic medications (including benzodiazepines, non-benzodiazepines, antidepressants, or hormone replacement therapy) for at least one month prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, lactating, or planning to become pregnant in the near future. 2. Patients with severe diseases of the heart, liver, kidneys, or hematopoietic system, or with a history of poorly controlled psychiatric disorders. 3. Patients with intracranial tumors, cognitive impairments, or those unable to cooperate with the investigation. 4. Patients currently participating in or having participated in another clinical drug trial within the past month. 5. Patients who had sleep disorders prior to their confirmed diagnosis of a malignant tumor. 6. Patients with a history of substance abuse or drug dependence. 7. Patients who have experienced severe psychological trauma recently, such as the death of a family member or close friend.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index; | — |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol Five-Dimensional Five-Level;Hamilton Anxiety Scale;Hamilton Depression Scale;Insomnia Severity Index;Sleep apnea monitoring data / Data from sleep respiratory monitoring; | — |
Countries
China
Contacts
Public ContactYabin Gong Chengxiu Zhong
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed