The Efficacy and Safety of a Compound Glutamine Capsule in the Primary Prevention of Chemotherapy-induced Mucositis
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.