Opioid-Induced Constipation (OIC)
Conditions
Interventions
Experimental group:Lactulose Oral Solution
Control group:Liuwei Nengxiao capsule
Sponsors
Chengdu Integrated TCM&Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all the following inclusion criteria: 1. Diagnosed with malignant tumor via histopathological, cytopathological, or imaging examinations; 2. Confirmed to have moderate to severe cancer pain (NRS score 4-10) before analgesic treatment and receiving opioid-based analgesia; 3. Meeting the diagnostic criteria for OIC (opioid-induced constipation) in the 2016 fourth edition of Rome IV Functional Gastrointestinal Disorders: Disorders of Gut-Brain Interaction; 4. Aged >=18 years, regardless of gender; 5. Expected survival period >3 months; 6. Karnofsky Performance Status (KPS) >=60 points; 7. Not having used other constipation-inducing medications (including antihistamines, 5-HT3 receptor antagonists, anticholinergic drugs, antidepressants, anticonvulsants, etc.) or Chinese/western laxatives within 2 days before treatment; 8. Not having undergone chemotherapy within 14 days prior to enrollment and having no planned chemotherapy during the treatment period; 9. Voluntarily participating in the clinical trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following exclusion criteria: 1. Intolerance to opioid analgesics (opioid intolerance is defined as the inability to take opioids regularly for at least 7 days, or a daily total dose that cannot reach: oral morphine 60 mg/day, fentanyl transdermal patch 25 µg/h, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or equivalent doses of other opioids); 2. Patients with constipation caused by organic diseases of the colon or rectum, or acute intestinal obstruction; 3. Patients allergic to the study drug or its components; 4. Pregnant or lactating women, or females with childbearing plans during the study period; 5. Patients with severe mental disorders or a history of alcohol and drug abuse; 6. Patients with severe dysfunction of the heart, liver, kidneys, hematopoietic system, etc. (heart: symptoms related to reduced cardiac ejection fraction; liver: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >3 times the upper limit of normal; kidneys: creatinine >3 times the upper limit of normal; hematopoietic system: hemoglobin <8.0 g/dL requiring blood transfusion, or white blood cells <1.0×10^9/L, or platelets <50.0×10^9/L) or severe infections; 7. Factors affecting intestinal transit function, such as intestinal paralysis, intestinal foreign bodies, intestinal inflammation, intussusception, etc.; 8. Patients participating in other clinical trials during the same period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous bowel movement (SBM) response rate ;The time from the first medication to the first CSBM;The incidence of SBM and CSBM within 4, 8, 12, and 24 hours after the first medication administration;Bowel Function Index(BFI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the frequency of weekly SBM ;Changes in the frequency of weekly CSBM ;Changes in the frequency of weekly effortless SBM ;The time from the first medication to the first SBM;Bristol stool form scale(BSFS);Quality of Life;The recurrence of constipation and the time of the first recurrence;The total cost of constipation treatment during the treatment period;The cost of medications for the treatment of constipation during the treatment period; | — |
Countries
China
Contacts
Public ContactDuan Ping
Chengdu Integrated TCM&Western Medicine Hospital
Outcome results
None listed