Last updated: October 11, 2021
Sponsor: Meng Qiu
Overall Status: Active - Recruiting
Phase
3
Condition
Mucositis
Treatment
N/AClinical Study ID
NCT04988971
2021615
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age: 18-75 years old; Sex: Male or female;
- Pathologically confirmed gastric adenocarcinoma or colorectal adenocarcinoma;
- Patients who had received standard chemotherapy containing platinum or irinotecandeveloped grade 1-3 (NCI-CTCAE, version4.0) diarrhea in the previous cycle andrecovered to grade 0 after symptomatic treatment;
- Patients are planned to receive the same chemotherapy regimen and dose as the previouscycle;
- A baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Adequate haematopoietic function of bone marrow: neutrophils≥1.5x109 / L,platelets≥75x109 / L; normal liver and kidney function: TBIL≤ 1 upper limit of normal (ULN); ALT and AST ≤2.5 ULN; creatinine≤1.5 ULN;
- Estimated life expectancy ≥ 3 months;
- Be willing and able to provide written informed consent for the trial.
Exclusion
Exclusion Criteria:
- (Patient-Generated Subjective Global Assessment, PG-SGA)>9 or severe malnutrition (weight loss > 10% or serum albumin < 30 g/L or body mass index < 18.5 kg/m2);
- Patients with severe heart, lung and brain diseases; chronic hepatitis infection,liver cirrhosis, chronic nephritis, kidney dysfunction, etc;
- Patients with infection-related fever;
- Patients who are known to be allergic or intolerant to any of the ingredients used inthe study;
- Patients with long-term chronic diarrhea, abdominal pain, constipation or otherdigestive tract diseases; patients with gastrointestinal symptoms before chemotherapy (≥grade 2 NCI-CTCAE, version 4.0);
- Synchronously receive other treatments that may cause diarrhea, such as radiotherapy;
- Patients who take drugs for microecological regulation of digestive tract such asCombined Bifidobacterium, ChangTai oral liquid, etc;
- Patients take traditional Chinese medicine or antibiotics;
- Unable to understand and sign the informed consent form;
- participants in other clinical trials.
Study Design
Total Participants: 90
Study Start date:
June 30, 2021
Estimated Completion Date:
December 31, 2022
Connect with a study center
Meng Qiu
Sichuan,
ChinaActive - Recruiting
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