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The Efficacy and Safety of a Compound Glutamine Capsule in the Primary Prevention of Chemotherapy-induced Mucositis

NCT ID: NCT05092113

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mucositis Chemotherapeutic Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

a compound glutamine capsule/a compound glutamine capsule simulated placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

a compound glutamine capsule/a compound glutamine capsule simulated placebo

Intervention Type DRUG

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.

Interventions

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a compound glutamine capsule/a compound glutamine capsule simulated placebo

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meng Qiu

OTHER

Sponsor Role lead

Responsible Party

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Meng Qiu

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Meng Qiu

Sichuan, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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meng qiu

Role: primary

[email protected]
18980601776

Other Identifiers

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2021-615

Identifier Type: -

Identifier Source: org_study_id