Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.
研究概览
简要总结
To evaluate the effect of two repeated intraglandular injections with ASCs, relative to placebo, in improving unstimulated whole salivary flow rate in radiation-induced xerostomia 8 months from baseline.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
- •WHO Performance status 0-1
- •Presence of xerostomia daily
- •UWS of 0.05 mL/min to 0.5 ml/min
- •Age above 18
- •Informed consent
排除标准
- •Any active cancer in the previous 0,5 year (not including the head and neck cancer and basocellular carcinomas)
- •Xerogenic medications at inclusion
- •Penicillin or streptomycin allergy assessed by health personnel
- •Any other previous or active disease of the salivary glands (e.g. Sjögren’s Disease, sialolothiasis)
- •Previous submandibular surgery or biopsy
- •Pregnancy or planned pregnancy until 4 months after second treatment
- •Breastfeeding
- •Smoking within the last 6 months
- •Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)
结局指标
主要结局
The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.
The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.
次要结局
未报告次要终点
研究者
Joachim Hansen
Scientific
Rigshospitalet