Tumor
Conditions
Interventions
Experimental group A:Intestinal probiotic preparations
Experimental group B:Maltodextrin
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Participants must be pathologically diagnosed with malignant solid tumors (excluding hematologic malignancies), and the clinical stage of the tumor should be between stage IIIB and IV. (2) They should have undergone at least one cycle of chemotherapy, with an expectation of receiving two or more additional cycles of chemotherapy in the future (chemotherapy cycles based on a 21-day period). (3) Patients with a subjective fatigue level screening score of =4 on the fatigue level screening questionnaire. (4) Normal cognitive function, capable of independently completing the questionnaires involved in the study. (5) Hematological, liver, kidney function, and vital organ function parameters should meet the requirements for chemotherapy. (6) No significant swallowing impairment, able to orally take the investigational product smoothly. (7) Informed and willing to participate in this clinical trial, with a signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with other specific causes leading to fatigue, such as hypothyroidism, insomnia, uncontrolled pain, moderate to severe anemia, severe malnutrition, cachexia, etc. (2) Allergy to the ingredients in this product formula, such as Lycium barbarum, ginseng, probiotics, etc. (3) Currently taking prescription stimulants or other medications/supplements clearly indicated for anti-fatigue purposes. (4) Patients with symptomatic intracranial metastases. (5) Concurrent mental disorders (anxiety, bipolar disorder, obsessive-compulsive disorder, schizophrenia), acute or chronic progressive, or unstable neurological conditions (dementia, delirium, or epilepsy); presence of cognitive impairment. (6) Concurrent other diseases requiring treatment with glucocorticoids (excluding chemotherapy pre-treatment). (7) Poor compliance, patients expected to deviate from the study plan. (8) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life;fatigue; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal side effects;Number and composition of gut microbiota;nutritional status;immunity; | — |
Countries
China
Contacts
Public ContactSun Yu
West China Hospital, Sichuan University
Outcome results
None listed