Mucositis Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02252926 -
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
|
Phase 2 | |
| Completed |
NCT01155609 -
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
|
N/A | |
| Completed |
NCT00357942 -
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
|
Phase 4 | |
| Completed |
NCT00360685 -
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
|
N/A | |
| Completed |
NCT04586491 -
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
|
N/A | |
| Withdrawn |
NCT02589860 -
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
|
||
| Not yet recruiting |
NCT02506231 -
The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome
|
Phase 2/Phase 3 | |
| Completed |
NCT02639377 -
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
|
Phase 2 | |
| Completed |
NCT02605382 -
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis
|
Phase 2 | |
| Terminated |
NCT02575313 -
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00956254 -
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
|
Phase 3 | |
| Completed |
NCT00584597 -
A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
|
Phase 1 | |
| Enrolling by invitation |
NCT05590117 -
Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer
|
Early Phase 1 | |
| Completed |
NCT05635929 -
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.
|
N/A | |
| Completed |
NCT05181943 -
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
|
N/A | |
| Completed |
NCT03713567 -
Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis
|
N/A | |
| Completed |
NCT02671812 -
Outcome After Dental Implant Treatment
|
||
| Terminated |
NCT02273752 -
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
|
Phase 2 | |
| Recruiting |
NCT01707641 -
Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
|
Phase 4 | |
| Completed |
NCT01015183 -
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
|
Phase 2/Phase 3 |