At a glance
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Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
In Brief
A Phase 2 clinical trial evaluating Kanglaite and chemotherapy for Head and Neck Cancer and Radiotherapy. Completed, enrolled 53 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Kanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy.
Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.