Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study
Condition: Head and Neck Cancer; Radiotherapy
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      3-4 grade radiation mucositis account for 34%-56% in all head and neck patients treated by
      radiotherapy and >50% in patients treated by radiotherapy concurrent with chemotherapy. 3-4
      grade radiation mucositis have obvious symptoms, presenting with fusion ulcers, ulcers
      bleeding or obvious pain need analgesic drugs. At this time, the patients can not eat or can
      only intake fluid diet, which led to weight loss, malnutrition, quality of life declined and
      a series of problems.

      Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite can reduce
      radiotherapy mucositis of nasopharyngeal cancer had been found initially in Chinese.
      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 evaluation the acute radiation mucositis, nutritional
      status, and quality of life on the course of radiotherapy of head and neck malignant tumors.

      Kanglaite 200ml is injected intravenous from the first day to the last day of radiotherapy.
      Chemotherapy with cisplatin or nedaplatin (both 80-100mg/m2, 21 day per cycle, 1-3 cycles) is
      used or not concurrent with radiotherapy. There is no order of Kanglaite injection and
      radiotherapy. Granulocyte colony stimulating factor and antibiotics have no prophylactic use,
      but can be used after the decline of white blood cells. Mucositis, nutritional status, and
      quality of life are evaluated before radiotherapy, every week of radiotherapy, 4 weeks after
      radiotherapy. Mucositis is verified by physical examination. Nutritional status is evaluated
      by patient-generated subjective global assessment (PG-SGA) scale. Quality of life is
      evaluated by EORTC QLQ-C30 and QLQ-H&N35 questionnaire.

      This is a one arm study, sample size calculation based on the incidence of 3-4 degree
      mucositis. The incidence of 3-4 degree mucositis is about >50% according to literatures of
      head and neck squamous cell carcinoma intensity modulated radiation therapy concurrent with
      chemotherapy. So we assume that Kanglaite can reduce 3-4 degree mucositis from 50% to 30%.
      The sample size required 44 cases according to the superiority test, bilateral Class I error
      α = 0.05, class II error β = 0.2. Total 49 cases are need, assuming the off rate of 10%.
    

Intervention name(s): Kanglaite; chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Kanglaite injection; Concurrent chemotherapy
Intervention model: Single Group Assignment
Intervention model description: Kanglaite injection + Radiotherapy ± Chemotherapy
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: head and neck; tumor; radiotherapy; mucositis; toxicity; Kanglaite injection