Opioid-related constipation in cancer pain patients
Conditions
Interventions
Test group:Drug therapy
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years (including boundary values) gender unrestricted; 2. Histologically or cytologically tumor with pain requiring opioid treatment taking opioids for at least 1 month and developing constipation symptoms after taking opioids confirmed as opioid-induced constipationOIC); 3. Received stable opioid treatment (opioid dose within 100% to 200%) in the 14 days prior toing; 4. Met the clinical symptom criteria for functional constipation in "Rome ?" within 1 week before the screening period; 5. The's physical condition meets the Eastern Cooperative Oncology Group (ECOG) score =2 with an expected survival period of =3 months and the tumor does directly affect gastrointestinal function with the tumor condition being relatively stable during the study period without rapid progression of the disease; 6. Fully understands the trial process to participate and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with an allergic constitution or known or suspected allergies to the trial drug or its components; 2. Those who have previously constipation due to the use of chemotherapy or antiemetic drugs; 3. Participants with habitual constipation or constipation that may be caused by other diseases as cancer that directly affects gastrointestinal function inflammatory bowel disease megacolon enteritis intestinal obstruction anorectal lesions parathyroid disease or other abdominal lesions (e.g. ascites) that compress the intestines; 4. Those with other serious systemic diseases that may affect the trial evaluation such as cardiovascular respiratory renal hematological endocrine neurological and psychiatric conditions; 5. Individuals with "alarm signals" such as moderate to anemia (hemoglobin concentration 3×UL or in the presence of liver metastases ALT AST >5×ULN or Cr >1.5×ULN; 7. Sus or confirmed history of alcohol or drug abuse; 8. Pregnant or lactating women or those planning to become pregnant; 9. Those who have participated in drug clinical trials within one month prior to enrollment; 10. Other individuals deemed unsuitable for the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Assessment of Constipation Symptom (PAC-SYM);Evaluation of the number of times for CSBM SBM and BM; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea and vomiting NRS score;Time of SBM, CSBM within 48 hours after starting medication;Patient Assessment of Constipation-Quality of Life (PAC-QOL);Cancer Patient Quality of Life Questionnaire (EORTC QLQ-C15-PAL);Pain intensity NRS score;Weekly stool characteristics Bristol stool form scale score; | — |
Countries
china
Contacts
Public Contacthuijie li
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed