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临床试验/NCT01707641
NCT01707641Unknown4 期

A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.

S. Andrea Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
140
试验地点
2
主要终点
incidence of grade III/IV mucositis

研究概览

简要总结

Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. The main endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of grade III and IV mucositis as well as increase the percentage of patients who will complete the radio-chemotherapy treatment.

详细描述

Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology patients. It is not only painful, but also can limit adequate nutritional intake and decrease the willingness of patients to continue the treatment. Furthermore, extensive mucositis may require additional nutritional supplementation, and narcotic analgesic increasing the cost of the therapy. Quality of life is impaired in patients who develop severe mucositis.

Clinically, it begins with asymptomatic redness and erythema and ultimately passing through different stages to large acutely painful contiguous pseudomembranous lesions with associated dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal, soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the epithelial cells exposes the underlying connective tissue with its associated innervations causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further exacerbate the mucositis as well as lead to systemic infections.

Treatment and prevention of therapy related mucositis is essential; unfortunately, the efficacy and safety of most of the regimen used have not been clearly established. Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as mouthwash. Oral or parenteral narcotics are also used for pain relief.

There is a clear need for new therapeutic options for oral mucositis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male and female patients > 18 years of age
  • Karnofsky Performance Status >70%
  • pathological and histological diagnosis that confirms head and neck tumour
  • patients eligible for radical radiotherapy and/or chemotherapy
  • expected survival time > 6 months
  • normal bone marrow function (neutrophil count >1500/cmm, platelet count > 100.000/CMM)
  • serum creatine < 1.8mg/dl
  • total bilirubin <2mg/dl
  • GOT, GPT within 3 times the normal limit
  • willingness to perform conventional 3D radiotherapy or intensive modulated radiation therapy with concurrent chemotherapy
  • signed informed consent form

排除标准

  • Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
  • Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
  • Major surgery of the oral cavity within the last 4 weeks
  • Patients previoucly treated with radiotherapy of head and neck
  • Antifungal or antiviral therapy for oral pathological conditions in the last
  • Other serious concomitant disease
  • History of insulin-dependent Diabetes Mellituss
  • History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
  • Patients with body weigh >35 kg
  • Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
  • Patients with Hepatitis B / C
  • Patients with symptomatic untreated dental infection
  • Patients with oral mucositis grade NCICTC 3 or 4
  • Histological and pathological diagnosis unavailable
  • Patients with signs and symptoms of systemic infection
  • Patient's refusal to sign the informed consent

结局指标

主要结局

incidence of grade III/IV mucositis

时间窗: 2 months

Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)

次要结局

  • percentage of patients able to complete the chemo-radiotherapy treatment(2 months)

研究者

发起方
S. Andrea Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vitaliana De Sanctis

M.D. University Researcher

S. Andrea Hospital

研究点 (2)

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