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Official title Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
ClinicalTrials.gov ID: NCT07477522
What this study is testing
- What it's testing
- Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, \>90 % being solid cancers.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- (1) Sign a written informed consent form before any study - related procedures are carried out.
- (2) Males or females, aged 18 - 80 years old. (3) Diagnosed with solid tumors by pathological tissue biopsy. (4) According to the RECIST v1.1...
- (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1.
- (6) NRS - 2002 (Nutritional Risk Screening 2002) score \< 3. (7) BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual...
- (8) Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.
You likely can't join if
- (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.
- (2) Patients with central nervous system or meningeal metastases. (3) Patients with clinically symptomatic moderate or severe ascites (that is, those...
- (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.
- (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction...
- (6) Patients known to be allergic to the active ingredients or excipients of the study drug.
- (7) Patients with poorly controlled diabetes. (8) Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic...
See the full eligibility criteria
Who can join
- (1) Sign a written informed consent form before any study - related procedures are carried out.
- (2) Males or females, aged 18 - 80 years old. (3) Diagnosed with solid tumors by pathological tissue biopsy. (4) According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is...
- (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1.
- (6) NRS - 2002 (Nutritional Risk Screening 2002) score \< 3. (7) BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation).
- (8) Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.
- (9) Sufficient organ function, and the people need to meet the following laboratory indicators: In the absence of granulocyte - colony - stimulating factor use in the past 14 days, the absolute neutrophil count ≥...
- Platelets ≥ 75×10⁹/L. In the absence of blood transfusion or erythropoietin use in the past 7 days, hemoglobin ≥ 8 g/dL.
- Serum albumin ≥ 3.0 g/dL. Total bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. In case of liver metastasis, ALT and/or AST ≤ 5×ULN, and...
- Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft - Gault formula) or serum creatinine ≤ 1.5×ULN.
- International Normalized Ratio (INR) ≤ 1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN.
- Urine protein \< 2+ (if urine protein ≥ 2+, a 24 - hour urine protein quantification can be performed, and people with a 24 - hour urine protein quantification \< 2.0 g can be enrolled).
- (10) Women of child - bearing potential must agree to avoid sexual intercourse (heterosexual intercourse) or use a reliable and effective contraceptive method from the signing of the informed consent form until at least...
- (11) If there is a risk of pregnancy, all people (regardless of male or female) need to use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period until 120 days after the...
What rules you out
- (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.
- (2) Patients with central nervous system or meningeal metastases. (3) Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start...
- (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.
- (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal...
- (6) Patients known to be allergic to the active ingredients or excipients of the study drug.
- (7) Patients with poorly controlled diabetes. (8) Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg under routine antihypertensive treatment)...
- (9) Patients with severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before...
- (10) Pregnant or lactating women. (11) Other situations considered by the investigator as inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.