Cancer patients on opioid therapy have manageable pain but experience persistent constipation.
Conditions
Interventions
Sponsors
Changzhou NO.2 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)malignant tumors based on histopathological or cytological confirmation; 2)Patients aged 18 to 80 years, with clear consciousness, regardless of gender, admitted as inpatients or outpatients; 3) Patients experiencing cancer-related pain requiring opioid therapy; 4)Patients have received opioid treatment for at least 2 weeks prior to obtaining informed consent, with a stable opioid dose and NRS =3 months; 9) ECOG performance status <=2; 10)Patients are able to understand, voluntarily sign the informed consent form, and comply with study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with non-cancer pain or pain of unknown origin; 2) Patients unable to swallow capsules orally; 3) Patients with severe intestinal mucosal damage or significant gastrointestinal disorders, including but not limited to: gastrointestinal obstruction, irritable bowel syndrome, inflammatory bowel disease, active diverticulitis, hypothyroidism, hypopituitarism, pelvic disorders causing constipation such as uterine or rectal prolapse; 4) Patients with concurrent infections requiring antibiotic therapy; 5) Patients with severe hepatic or renal insufficiency (creatinine >= 2 times the upper limit of normal, ALT/AST >= 2.5 times the upper limit of normal, liver metastasis or hepatocellular carcinoma patients >= 5 times the upper limit of normal, or Child C liver function), or severe cardiopulmonary insufficiency; 6) Patients with cognitive impairment; 7) Pregnant or breastfeeding patients; 8) Patients who have not had a bowel movement for 7 consecutive days to reduce the risk of bowel perforation; 9) Cancer patients whose OIC is relieved by laxatives; 10) Other diseases and conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of constipation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life;Nutritional status;Serum metabolomics;Changes in microbiota;cancer pain; | — |
Countries
China
Contacts
Public ContactHua Jiang
Changzhou NO.2 People's Hospital
Outcome results
None listed