Back to resultsThe Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis
Primary Purpose
Mucositis, Chemotherapeutic Toxicity
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
a compound glutamine capsule
a compound glutamine capsule simulated placebo
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis
Eligibility Criteria
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 irinotecan developed grade 1-3 (NCI-CTCAE, version4.0) diarrhea in the previous cycle and recovered to grade 0 after symptomatic treatment;
- Patients are planned to receive the same chemotherapy regimen and dose as the previous cycle;
- 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 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.
Sites / Locations
- Meng QiuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group C
Group D
Arm Description
during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsules, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsule simulated placebo, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
Outcomes
Primary Outcome Measures
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
Secondary Outcome Measures
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1
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)
Overall incidence of grade 3/4 gastrointestinal adverse events
Overall incidence of grade 3/4 gastrointestinal adverse events according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04988971
Brief Title
The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis
Official Title
The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis in Patients With Gastrointestinal Tumors: a Prospective, Randomized, Controlled, Double-blind, Phase III Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meng Qiu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Chemotherapeutic Toxicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Experimental
Arm Description
during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsules, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsule simulated placebo, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
Intervention Type
Drug
Intervention Name(s)
a compound glutamine capsule
Intervention Description
A compound glutamine capsule 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.
Intervention Type
Drug
Intervention Name(s)
a compound glutamine capsule simulated placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1
Description
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
Time Frame
At the end of Cycle 1(each cycle is 14/21 days)
Secondary Outcome Measure Information:
Title
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1
Description
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)
Time Frame
At the end of Cycle 1(each cycle is 14/21 days)
Title
Overall incidence of grade 3/4 gastrointestinal adverse events
Description
Overall incidence of grade 3/4 gastrointestinal adverse events according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
Time Frame
At the end of Cycle 1(each cycle is 14/21 days)
Other Pre-specified Outcome Measures:
Title
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
Description
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
Title
Changes of fecal flora and enteritis-associated inflammatory factors
Description
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.
Time Frame
an average of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 irinotecan developed grade 1-3 (NCI-CTCAE, version4.0) diarrhea in the previous cycle and recovered to grade 0 after symptomatic treatment;
Patients are planned to receive the same chemotherapy regimen and dose as the previous cycle;
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
meng qiu, Doctor
Phone
18980601776
Email
qiumeng@wchscu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
meng qiu, Doctor
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Meng Qiu
City
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
meng qiu
Phone
18980601776
Email
qiumeng@wchscu.cn
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis
We'll reach out to this number within 24 hrs