NCT04988971

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Meng Qiu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucositis
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
DRUG	a compound glutamine capsule	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.
DRUG	a compound glutamine capsule simulated placebo	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.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-07-01
• Completion: 2022-12-31
• First posted: 2021-08-04
• Last updated: 2021-10-15

Locations

1 site across 1 country: China