RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
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赞助商
Abnoba Gmbh
临床试验: NCT01401075
BioSeek: nct01401075
关键词
抽象
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
日期
| 最后验证: | 06/30/2011 |
| 首次提交: | 07/21/2011 |
| 提交的预估入学人数: | 07/21/2011 |
| 首次发布: | 07/24/2011 |
| 上次提交的更新: | 11/05/2012 |
| 最近更新发布: | 11/06/2012 |
| 实际学习开始日期: | 02/28/2006 |
| 预计主要完成日期: | 03/31/2008 |
| 预计完成日期: | 03/31/2008 |
状况或疾病
Gastric Cancer
干预/治疗
Drug: doxifluridine + mistletoe extract
Drug: doxifluridine
相
相 4
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: doxifluridine oral chemotherapy with the 5-FU prodrug doxifluridine | |
| Experimental: doxifluridine + mistletoe extract oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection | Drug: doxifluridine + mistletoe extract subcutaneous injections thrice weekly with 1 ml in 4 increasing doses |
资格标准
| 有资格学习的年龄 | 19 Years 至 19 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - postoperative UICC stage Ib/II gastric carcinoma - indication for oral chemotherapy with doxifluridine - ECOG performance status 0 or 1 - normal liver and kidney function Exclusion Criteria: - inability to answer the QoL scales - concomitant therapy with steroids or biological response modifiers - individual hypersensitivity to mistletoe preparations - pregnancy or lactating - participation in another clinical trial |
结果
主要结果指标
1. Quality of Life [24 weeks]
EORTC Quality of Life Questionnaires:
QLQ-C30
QLQ-STO22
次要成果指标
1. Immunomodulation [24 weeks]
cytokine levels (TNF-alpha and interleukin-2)
lymphocyte subsets (CD 16+/CD56+ and CD 19+)
2. Safety and tolerability [24 weeks]
differential blood count
liver functions tests
adverse events
