Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
About 89%-100% patients with head and neck malignant tumors have radiation mucositis during
their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid
hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used
after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its
trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has
anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the
quality of life of patients and mitigate the condition of the cachexia. In china, two studies
evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce
radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation
mucositis of the head and neck malignant tumor is still lack of strong clinical trial
evidence. This is a phase II, single center, one arm study with subject to evaluate the acute
radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of
head and neck cancer.
Phase:
Phase 2
Details
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University