- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092113
The Efficacy and Safety of a Compound Glutamine Capsule in the Primary Prevention of Chemotherapy-induced Mucositis
October 11, 2021 updated by: Meng Qiu
The Efficacy and Safety of a Compound Glutamine Capsule in the Primmary Prevention of Chemotherapy-induced Mucositis in Patients With Gastrointestinal Tumors: a Prospective, Randomized, Controlled, Double-blind, Phase III Clinical Study
Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on.
These adverse reactions seriously affect the patients' quality of life and the efficacy of chemotherapy.
Glutamine is a conditionally essential amino acid in the human body.
Previous studies have shown that oral glutamine can help to keep the integrity of mucosal epithelium during chemotherapy and reduce the gastrointestinal side effects caused by chemotherapy.
The addition of glutamine to parenteral nutrition can better maintain nitrogen balance and reduce the incidence of infection-related complications.
A compound glutamine capsule, composed of L-glutamine and the traditional Chinese herbal formula Si-Jun-Zi-Tang which composed of ginseng, Atractylodes macrocephala, Poria cocos and licorice, has been widely used in China for 23 years to treat many types of gastrointestinal diseases, including gastrointestinal reactions induced by radiotherapy and chemotherapy, ulcerative colitis, irritable bowel syndrome.
However, so far, only a small sample of clinical trials have explored the role of glutamine in chemical mucositis, and there is a lack of prospective randomized controlled clinical trials to further verify its value in the prevention and treatment of chemical mucositis.
The purpose of this study is to observe the efficacy and safety between a compound glutamine capsule and placebo in the prevention of chemotherapy-induced mucositis in patients with gastric cancer and colorectal cancer in a prospective, randomized, double-blind clinical trial.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sichuan, China
- Recruiting
- Meng Qiu
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Contact:
- meng qiu
- Phone Number: 18980601776
- Email: qiumeng@wchscu.cn
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18-75 years old; Sex: Male or female
- Pathologically confirmed gastric adenocarcinoma or colorectal adenocarcinoma.
- Patients are ready to receive chemotherapy regimens containing platinum or irinotecan (targeted therapy could be used at the same time). Patients have not received any anti-cancer treatment before.
- patients are planned to receive the same chemotherapy regimen at least 2 cycles
- 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.
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 in the study;
- Patients with long-term chronic diarrhea, abdominal pain, constipation or other digestive 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 as Combined 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
a compound glutamine capsule was taken orally in the first cycle of chemotherapy, and a compound glutamine capsule simulated placebo was taken in the second cycle of chemotherapy.
All patients take drugs orally on the first day of each cycle of chemotherapy, 3 tablets 3 times a day, and the course of the treatment was 3 weeks.
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A compound glutamine capsule/a compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
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Experimental: Group B
in the first cycle of chemotherapy, a compound glutamine capsule simulated placebo was given ,and in the second cycle, a compound glutamine capsule was taken at the same time of chemotherapy.
All patients take orally from the first day of chemotherapy, 3 times a day after meals, 3 tablets each time, and the course of treatment was 3 weeks.
|
A compound glutamine capsule/a compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1
Time Frame: up to 3 weeks
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Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
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up to 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1
Time Frame: up to 3 weeks
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Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1 (including oral mucositis, nausea, vomiting, abdominal pain, stomachache, and other types, according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
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up to 3 weeks
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Overall incidence of grade 3/4 gastrointestinal adverse events
Time Frame: up to 3 weeks
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Overall incidence of grade 3/4 gastrointestinal adverse events according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
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up to 3 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of scores of Quality of Life Questionare-Core 30 of the European Organization for Research and Treatment of Cancer of patients between interventional group and control group before and after this cycle of chemotherapy
Time Frame: an average of 3 weeks
|
Changes of scores of Quality of Life Questionare-Core 30 of the European Organization for Research and Treatment of Cancer of patients between interventional group and control group before and after this cycle of chemotherapy
|
an average of 3 weeks
|
Changes of fecal flora and enteritis-associated inflammatory factors
Time Frame: an average of 3 weeks
|
find the differences in the composition structure of the microbial community in the feces sample by 16SrDNA amplification techniques.Detect changes of calprotectin in patients in feces.
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an average of 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
September 12, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (Actual)
October 25, 2021
Study Record Updates
Last Update Posted (Actual)
October 25, 2021
Last Update Submitted That Met QC Criteria
October 11, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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