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
Intervention: Kanglaite; chemotherapy
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Kanglaite injection + Radiotherapy ± Chemotherapy
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: head and neck; tumor; radiotherapy; mucositis; toxicity; Kanglaite injection

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-80 years old, expected survival period ≥ 12 months

          2. Karnofsky score ≥80 points

          3. Pathological confirmed head and neck malignant tumors (oral, oropharynx, hypopharynx,
             throat, nasopharynx, nasal paranasal sinus or other), radical radiotherapy (±
             chemotherapy) or postoperative radiotherapy (± chemotherapy), radiotherapy dose 60
             -70Gy

          4. with or without induction chemotherapy (induced chemotherapy ≤ 3 cycles);

          5. Meet the following laboratory diagnostic indicators:

             Hemoglobin ≥120g / L, white blood cells 4.0-10.0 × 109 / L, neutrophils 2.0-7.5 × 109
             / L, platelets 100-300 × 109 / L; creatinine ≤ normal upper limit (UNL); ALT and AST ≤
             2.5 × UNL, alkaline phosphatase (ALP) ≤ 5 × UNL, total bilirubin (Tbil) ≤ UNL

          6. Sign informed consent.

        Exclusion Criteria:

          1. Distant metastases

          2. Allergy to Kanglaite

          3. Head and neck had previously received radiation therapy

          4. Pregnancy or lactation patients

          5. Targeted drug therapy during radiotherapy

          6. Radio-chemotherapy uses cytotoxic drugs other than platinum

          7. Currently active infections, or combined with rheumatic immune diseases, long-term
             chronic infection, acute infection, inflammatory state; hematopoietic dysfunction of
             the blood system diseases; severe cardiopulmonary disease

          8. Mental history, can not cooperate with the treatment

          9. Researchers believe unsuitable to participate in this trial.