constipate
Conditions
Interventions
experimental group:Oral lubiprostone soft capsule, 24 µg/capsule, 1 capsule/time, once a day, take orally with food and water, swallow the capsule whole, do not split or chew
control group:Blank control
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Male or female, aged >= 18 years; 3. Expected survival >= 12 weeks; 4. Relatively regular bowel habits before enrollment, with frequency = 50%; (2) Hemoglobin >= 9 g/dL; (3) Absolute neutrophil count (ANC) >= 1.5 × 10?/L; (4) Platelets >= 100 × 10?/L; (5) For patients without liver metastases, serum total bilirubin <= 1.5 × upper limit of normal (ULN); for those with liver metastases, serum total bilirubin <= 3 × ULN; (6) For patients without liver metastases, ALT and AST <= 2.5 × ULN; for those with liver metastases, ALT and AST <= 5 × ULN; (7) Serum creatinine <= 1.5 × ULN; 6. For female subjects: they must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and for 6 months after the end of the study treatment. A serum or urine pregnancy test within 7 days before study enrollment must be negative, and they must not be breastfeeding. Male subjects should agree to use at least one medically acceptable contraceptive method (e.g., condoms, abstinence) during the study treatment period and for 6 months after the end of the study treatment; 7. Willing and able to comply with the trial and follow-up procedures; 8. Independent inclusion criteria for the two cohorts: - Cohort 1: Diagnosed with non-digestive system solid tumors, including but not limited to lung cancer, breast cancer, urothelial carcinoma, etc., who have not received prior systemic anti-tumor therapy (including neoadjuvant, adjuvant, or first-line therapy for advanced disease), and are scheduled to receive a chemotherapy regimen containing cisplatin or carboplatin; - Cohort 2: Diagnosed with digestive system solid tumors, including but not limited to gastric cancer, colorectal cancer, etc., who have not received prior systemic anti-tumor therapy (including neoadjuvant, adjuvant, or first-line therapy for advanced disease), and are scheduled to receive a chemotherapy regimen containing oxaliplatin.
Exclusion criteria
Exclusion criteria: Anyone meeting any of the following criteria cannot be enrolled in this study: 1. Known allergy to lubiprostone or any of its components; 2. Suspected or confirmed presence of any of the following diseases: active inflammatory bowel disease or diverticulitis, mechanical intestinal obstruction, perforation, toxic megacolon, or intestinal foreign body; 3. Spontaneous bowel frequency >1 time/day with stool consistency meeting Bristol Stool Scale score 6–7, or habitual diarrhea; 4. Major surgery within 4 weeks before the start of study drug administration that has not fully recovered; 5. The planned chemotherapy regimen includes irinotecan or ADC (antibody-drug conjugates); 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with interpretation of results, including active or progressive (severe) infection, uncontrolled diabetes mellitus, cardiovascular or cerebrovascular diseases (New York Heart Association class III or IV heart failure, second-degree or higher atrioventricular block, acute myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within the past 6 months [excluding lacunar infarction]), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and history of symptomatic bronchospasm), deep vein thrombosis, or pulmonary embolism; 7. Central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects who have previously received treatment for brain metastases may be considered for participation in this study provided that the condition has been stable for at least 3 months, no disease progression has been confirmed by imaging within 4 weeks before the first dose of study drug, all neurologic symptoms have returned to baseline, there is no evidence of new or enlarging brain metastases, and radiation, surgery, or steroid therapy has been discontinued for at least 28 days before the first dose of study treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability; 8. Pregnant or breastfeeding women; 9. Any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory finding that, in the investigator’s judgment, reasonably suggests that the patient has a condition or state that makes the patient unsuitable for use of the study drug, or that may affect the interpretation of study results, or places the patient at high risk; 10. Estimated poor compliance with the clinical study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of constipation during chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| First bowel movement time after chemotherapy;Brusto stool score;chronic constipation severity score;Constipation patient quality of life score; | — |
Countries
China
Contacts
Public ContactBa Yi
Peking Union Medical College Hospital
Outcome results
None listed