malignant tumor
Conditions
Interventions
Intestinal microecological preparation group:The usage of the intestinal microecological preparation JK-5G once a day, with 1 bag (2.5 grams) each time, combined with standard analgesic treatment.
Control group:Placebo +Standard analgesic treatment
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with histological or cytologically confirmed malignancy; 2. Age: 18-70 years old, both male and female; 3. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-3; 4. The general situation is acceptable; 5. Complete relevant clinical data; 6. Presence of cancer-related pain, i.e., numeric rating scale (NRS) score recorded in the first 24 hours>=4; 7. Diagnosis of cancer pain in opioid-tolerant patients, including refractory cancer pain; Opioid tolerance is defined as: Received opioid therapy for one week or more and meets any of the following: (1) >=25mcg/h fentanyl patch; mcg mcg: 1mcg=0.001mg; (2) > = 60 mg morphine per day; (3) Oral administration of >=30 mg of oxycodone orally daily; (4) Oral >=8mg hydromorphone daily; (5) Use of another opioid at the same analgesic dose as described above; The equivalent converted dose of commonly used opioids is: oral morphine tablets 60 mg = oxycodone tablets 30~40 mg = morphine injection 20 mg = hydromorphone injection 3 mg = sufentanil injection 20 µg; 8. Patients can eat orally normally; 9. With the consent of the person and signed the informed consent form, willing and able to comply with the planned visits, research treatment, laboratory tests and other trial procedures.
Exclusion criteria
Exclusion criteria: 1. Those who cannot eat orally normally; 2. Patients with poor general conditions, such as ECOG score > 4; 3. Patients with gastrointestinal perforation, acute pancreatitis, acute intestinal obstruction, acute cerebral infarction, acute fever, acute and chronic infectious diseases, and those who use antibiotics within 72 hours; Those who use traditional Chinese medicine within 72 hours; 4. Patients with liver and kidney insufficiency and congenital heart disease; 5. Pregnant and lactating women; 6. Patients with opioid allergy; 7. Known mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse; 8. According to the investigator's judgment, the subject has other factors that may lead to the forced termination of this study, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-throughput sequencing of fecal intestinal microbiota;Quality of Life (QLQ-C30); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Metabolomics;The incidence rate of adverse reactions caused by analgesic drugs;blood inflammatory cytokines;lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactChen Mengting
Chongqing University Cancer Hospital
Outcome results
None listed